U.S. patent application number 10/122711 was filed with the patent office on 2003-02-13 for methods and systems for managing informed consent processes.
Invention is credited to Califano, Andrea, Floratos, Aristidis, Holden, Arthur, Wang, David, Young, Peter.
Application Number | 20030033168 10/122711 |
Document ID | / |
Family ID | 23087640 |
Filed Date | 2003-02-13 |
United States Patent
Application |
20030033168 |
Kind Code |
A1 |
Califano, Andrea ; et
al. |
February 13, 2003 |
Methods and systems for managing informed consent processes
Abstract
The systems and methods provide a dynamic process for obtaining
and managing informed consent documentation. In general, the
dynamic informed consent process (DICP) makes use of an
intermediary organization, e.g., a trusted intermediary, which: (a)
provides ICFs which have been dynamically generated for a specified
trial or medical procedure and based on particular state or federal
requirements, if any; and (b) archives copies of signed ICFs. In
certain preferred embodiments, there may also be a procedure to
provide training materials, such as audio or video presentations,
to be viewed by prospective participants. In certain preferred
embodiments, the process also includes contacting subjects who have
signed ICFs in the event that there is a change of circumstance
which the subject may deem material to whether s/he would continue
to consent, or whether the participant needs to provide a different
type of consent to participate in particular event or trial.
Inventors: |
Califano, Andrea; (New York,
NY) ; Floratos, Aristidis; (Astoria, NY) ;
Wang, David; (Killdeere, IL) ; Young, Peter;
(New York, NY) ; Holden, Arthur; (Winnetka,
IL) |
Correspondence
Address: |
ROPES & GRAY
ONE INTERNATIONAL PLACE
BOSTON
MA
02110-2624
US
|
Family ID: |
23087640 |
Appl. No.: |
10/122711 |
Filed: |
April 15, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60283809 |
Apr 13, 2001 |
|
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Current U.S.
Class: |
705/3 |
Current CPC
Class: |
G16H 10/40 20180101;
G16H 10/60 20180101; G16B 50/30 20190201; G16B 50/00 20190201; G16H
40/20 20180101; G16H 10/20 20180101; G16B 50/40 20190201 |
Class at
Publication: |
705/3 |
International
Class: |
G06F 017/60 |
Claims
1. A process for obtaining informed consent from a human subject
for an action, comprising having the human subject store data
representative of medical and genetic information into a data
memory, having the human subject indicate a grant of informed
consent to be associated with the stored data, allowing querying
the stored data to determine the grant of informed consent
associated with the stored data, allowing the determination whether
the provided grant of consent is sufficient for the action and
includes a grant of consent to re-contact the human subject, and
allowing, in response to the determined grant of consent, to
contact the human subject to request the human subject to change
the associated grant of informed consent.
2. A process according to claim 1, further comprising having a
trusted third party control access to the stored medical and
biological data.
3. A process according to claim 1, wherein allowing the contacting
of the human subject includes having a trusted third party to
contact the human subjects.
4. A process according to claim 1 or 2, further including
encrypting the medical and genetic data stored in the data
memory.
5. A process according to claim 1, wherein allowing a human subject
to store medical and biological record data includes allowing the
human subject to store portions of the medical and biological
record data as clear text and portions in an encrypted format.
6. A process according to claim 4, wherein allowing queries of the
stored data includes allowing queries on encrypted medical and
genetic data.
7. A process according to claim 1, further including storing with
the medical and biological contact data for recontacting the human
subject.
8. A process according to claim 7, wherein the address is of the
type selected from the group consisting of an e-mail address, a
post address, patient code assigned to the human subject, an
address for the human subject's physician, and identity information
for the human subject patient.
9. A process according to claim 1, wherein contacting the human
subject to request the human subject to change the associated grant
of informed consent includes contacting the human subject by a
method selected from the group consisting of e-mail, mail, putting
a notice on a bulletin board, contacting the human subject's
physician, telephone, and using a portal the human subject is
authorized to access.
10. A process according to claim 1, further including providing a
form representative of the required grant of consent.
11. A process according to claim 1, wherein a plurality of human
subjects have stored data within the data memory, further
comprising determining which of the human subjects identified by
the query require a different grant of consent, and contacting the
identified human subjects with a request to change the granted
level of consent.
12. A process according to claim 11, wherein contacting the
identified human subjects includes delivering a form for changing
the granted level of consent.
13. A process according to claim 1, further including allowing a
human subject to change the consent data stored in the data
memory.
14. A process according to claim 13, wherein changing the consent
data includes any one of expanding the granted level of access,
reducing the granted level of access, and eliminating access.
15. A process according to claim 1, further comprising posting for
review by the human subject a notice identifying new actions that
the human subject may want to be part of.
16. A system for managing access to medical record and genetic
information of an individual to allow a biomedical professional to
find participants for a study, comprising a database having storage
for medical record data of an individual and having storage for
consent data representative of a limited grant of informed consent
provided by the individual for the data, a query tool that allows a
researcher to query the medical record data to identify an
individual of interest to the study and that returns to the
biomedical professional the consent data associated with medical
record and biological data that matches the query, a re-contact
mechanism for allowing the biomedical professional to indicate a
required grant of consent for the study and to contact the
individual and request the individual to alter the provided grant
of informed consent to comply with the required grant of informed
consent, and a consent mechanism for allowing the individual to
participate in the study by granting a new consent.
17. A system according to claim 14, having storage for medical
record and biological data representative of previously collected
biological samples, medical and genetic data.
18. A system according to claim 14, having a network web server for
providing access over a data network.
19. A system according to claim 14, further including an encryption
mechanism for encrypting the medical record data.
20. A system according to claim 17, wherein the query mechanism
includes means for performing a query on encrypted data.
21. A system according to claim 14, wherein the contact means
includes an e-mail process, a bulletin board process, and a process
for delivering information in an electronic data folder.
22. A system according to claim 14, including enrollment means for
receiving communications from individuals and determining, as a
function of the granted level of consent, whether to enroll the
individual in an action or study.
23. A system according to claim 14 further comprising a query
process having a process for sorting data records in a database as
a function of consent data stored in the database and associated
with data records stored therein
24. A computer readable medium having stored thereon instructions
for implementing a process for obtaining informed consent from a
human subject for an action, comprising having the human subject
store data representative of medical and genetic information into a
data memory, having the human subject indicate a grant of informed
consent to be associated with the stored data, allowing querying
the stored data to determine the grant of informed consent
associated with the stored data, allowing the determination whether
the provided grant of consent is sufficient for the action and
includes a grant of consent to re-contact the human subject, and
allowing, in response to the determined grant of consent, to
contact the human subject to request the human subject to change
the associated grant of informed consent.
Description
RELATED APPLICATIONS
[0001] This application relates to U.S. Provisional Application
U.S. Ser. No. 60/283,809 entitled "METHODS AND SYSTEMS FOR MANAGING
INFORMED CONSENT PROCESS" and filed Apr. 13, 2001, and to U.S.
application Ser. No. 09/939,200, Filed: Aug. 24, 2001, titled
METHOD FOR INDEXING AND STORING GENETIC DATA; both applications
naming Andrea Califano as a common inventor; the entire contents of
both applications being herein incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] Sequencing of the human genome will generate an avalanche of
genetic information to be linked with information about microbial,
chemical, and physical exposures; nutrition, metabolism, lifestyle
behaviors, and medications. Advances in DNA sequencing technology
and in the understanding of the human genome are ushering in a new
era of genomic medicine, one with dramatic potential to not only
benefit society through research involving human subjects, but also
to cause economic or psychosocial harms to clinical subjects and
their families. While in some cases such information may be
beneficial to research subjects and their families, there is also
potential for misinterpretation or misuse.
[0003] In today's medical environment, a health practitioner or
clinical trial sponsor would (or at least should) never consider
performing a medical procedure, such as a surgical or diagnostic
procedure, on a patient, or putting that individual in a clinical
trial, without first obtaining informed consent. This is not only
important from a risk management perspective, but is basic to the
proper practice of medicine.
[0004] Special concerns have arisen about the process of informed
consent, particularly when the risks and benefits of research
participation may not be fully known. Concerns have also arisen
about how best to prevent the preliminary or premature release of
research results and to protect the privacy of individuals who
choose to participate in genetics research. Current guidance and
protections need to be enhanced to deal with the special
considerations related to genetics research.
[0005] The information most often provided in obtaining consent to
participate in clinical trial includes the research procedure; the
purposes, risks, and anticipated benefits; alternative procedures
(where therapy is involved); and a statement offering the
opportunity to ask questions and to withdraw from the research at
any time. Federal regulations (45CFR46 and 10CFR745) require the
disclosure of a number of issues in any informed consent document.
They include such issues as potential benefits of the research,
potential risks to the donor, control and ownership of donated
material, long-term retention of donated material for future use,
and the procedures that will be followed. In addition, there are
several other disclosures that are of special importance for donors
of DNA for large-scale sequencing. These include:
[0006] The meaning of privacy and confidentiality of information in
the context of large-scale DNA sequencing, and how these issues
will be addressed;
[0007] The lack of opportunity for the donor to later withdraw the
libraries made from his/her DNA or his/her DNA sequence information
from public use;
[0008] The absence of opportunity for information of clinical
relevance, e.g., information regarding susceptibility to disease,
etc., to be provided to the donor or her/his family;
[0009] The possibility of unforeseen risks; and
[0010] The possible extension of risk to family members of the
donor or to any group or community of interest (e.g., gender, race,
ethnicity) to which a donor might belong.
[0011] Comprehension, the manner and context in which information
is received, is also another important issue in dealing with
informed consent. Many of the standard informed consent forms
currently used have often fatal practical limitations and they may
be inconsistently applied. Typically the forms are modified for
each specific medical, dental or psychiatric procedure. While this
is efficient, it rarely takes into account the impacts of the
differing information to be conveyed, the differing manners in
which it must be delivered (if read), and the differing attitudes
of the patient. Each of these naturally affect the dependability of
the form. In addition, as each doctor tries to alter a general form
for a specific procedure, personal biases can detract from the real
goal of the process. Even if each of these limitations were
recognized, until the present invention, it simply would not have
been practical to tailor a document not only doctor to doctor, but
also from day to day, and from patient mood to patient mood. This
latter aspect--that a given patient might have different needs from
day to day or hour to hour--has been an aspect that, until the
present invention, those skilled in the art could not readily
address. Those skilled in the art, the doctors and lawyers, simply
believed it was not possible to accommodate the needs of the
patient to this degree. While the need for controlled consistency
in this area has been openly sought by consumer protection groups,
medical groups, and malpractice insurance carriers, until the
present invention it was not deemed practical to attempt to utilize
a technique which could be varied to suit each specific
occasion.
[0012] Systems and methods that address these issues and develop
guidelines and frameworks for ensuring the safe and appropriate use
of genetic information are crucial to the success of large use of
genetic information are described below.
SUMMARY OF THE INVENTION
[0013] The systems and methods described herein include, inter
alai, systems that allow a person to control the use of their
medical and biological data on a continuous, selective and dynamic
manner. Specifically, the systems described herein include systems
that allow a person to store or have stored into a database their
medical and biological data. Along with the medical and biological
data, the person stores a grant of consent that indicates the types
of activities and uses to which the person agrees or consents. The
database links the stored data with the granted consent. As it can
be difficult for a person to understand what kind of consent should
be granted, in one embodiment, the system helps the person
determine what grant of consent to provide. To this end, the system
can guide the person through a process that helps the person
complete a consent form that indicates the different allowed uses
for the data. In a preferred embodiment, each grant of consent
includes an indication as to whether the person is willing to be
re-contacted at a later to date, wherein the re-contact is
typically for the purpose of requesting the person to consent to a
new treatment or use of their medical, genetic, demographic or
biological data. The grant of consent may be stored in a database
along with and in association with the medical, genetic, and/or
biological data.
[0014] The systems further include a query mechanism that an
interested party, such as a researcher, medical professional or
some other person may use to query the stored data to identify
individuals of interest. In one example, a researcher conducting a
study to determine the efficacy of a particular treatment or
regime, searches through the data to identify individuals that may
have a medical condition, a medical history, a genetic marker or
some other condition or conditions of interest to the researcher.
The query, when completed, provides a list of human subjects that
meet the criteria. To protect privacy, the actual identities of the
human subjects may be kept secret. In one practice, each person
that has provided data receives a client code that may be employed
to distinguish that person from the others that have stored data in
the system. Optionally, the code may also be employed to re-contact
the person. However, the code by itself lacks information that may
be employed to identify the person.
[0015] As can be seen from the above, the systems and methods
described herein allow, among other things, a medical professional
to identify persons that may benefit from taking part in a research
study and to anonymously re-contact the identified persons with a
request that they consent to the required use of their medical and
biological data.
[0016] In particular, in one aspect the invention provides
processes for obtaining informed consent from a human subject for
an action or a procedure. The human subject may be any person that
can give consent for an action or procedure. Thus it can be the
participant themselves, as well as a guardian, parent, or court
appointed agency. The action that may be consented to can be any
action or procedure, such as for example a surgical procedure or a
research study. Further, consent may be provided to allow the
system of individuals The process for obtaining the informed
consent may include having the human subject stored data that is
representative of medical and genetic information into a data
memory and having the human subject indicate a grant of informed
consent to be associated with the stored data. The process may then
allow the querying of the stored data to determine the grant of
informed consent associated with that stored data, and the allow
the determination of whether the provided grant of consent is
sufficient for the action and includes a grant of consent to
recontact the human subject. The process may then allow, in
response to the determined grant of consent, the re-contacting of
the human subject to request the human subject to change the
associated grant of informed consent. Typically the request is that
the human subject change the associated grant of informed consent
to a grant of consent that is appropriate, or required, for an
action or procedure that is being proposed by the interested
party.
[0017] In further embodiments, the process may include having a
trusted third party control access to the stored medical and
genetic data. The trusted third party may also broker
correspondence between the interested parties and the human
subject, thus providing greater security that interested parties
will not determine the identity of the human subjects that have
provided data. Thus in certain practices, the processes allow for
contacting the human subjects by having a trusted third party
contact the human subjects.
[0018] To further provide for privacy and anonymity, the processes
may allow for encrypting the data, or portions of the data, that is
stored in the data memory. In this process, the human subject may
be allowed to store portions of the medical and genetic data as
clear text and other portions in an encrypted format. Optionally,
the human subjects may further be able to control which portions of
the stored data may be searched by an interested party and which
portions of the stored data are to remain private. In further
practices, the human subject may further designate controls over
what types of interested parties may look at certain portions of
the stored data. Thus, the human subject may allow certain types of
interested parties, such as academic researchers, to view all the
stored data while other types of interested parties, such as
pharmaceutical companies, may be provided more limited access to
the stored data. In either case however, data that is encrypted for
storage, in some embodiments, may be made available in clear text
format to the query mechanism to allow for searching on encrypted
data. Thus, in certain embodiments, the human subject encrypts data
stored within the data memory for the purpose of protecting that
data while it is stored. However, during queries run by interested
parties, the processes may allow the interested parties to search
on encrypted data, typically by decrypting the data during the data
query process, so that this data may be viewed by the interested
parties that the human subject has authorized to view that
data.
[0019] In a further practice, the process will allow storing
medical and biological data as well as contact data that may be
employed for recontacting the human subject. The contact data may
be an address, such as an email address, a post address, a patient
code assigned to the human subject, an address for the human
subject's physician and/or any type of identity information that
may be employed for identifying the human subject. The method for
contacting the human subject may vary according to the application
and may include, email, telephone, post mail, and, in a preferred
embodiment, by posting messages on a portal, typically a web-based
network portal, that the human subject is authorized to access.
[0020] In a typical practice, the processes described herein are
capable of handling data for a plurality of human subjects. Thus a
plurality of human subjects may store data within the data memory.
The data in the data memory may be made available to authorized
interested parties for the purposes of identifying human subjects
that may benefit from an action or procedure being carried out by
the interested party. Thus, interested parties may employ the
processes described herein for determining which of the human
subjects that have stored data within a data memory have data that
meets certain criteria set out in the query. The processes may
return the grant of consent that had been earlier provided by the
human subjects. The process allows for contacting the identified
human subjects with a request to change the granted level of
consent.
[0021] Optionally, the process may contact the identified human
subjects, thus providing the interested party with a platform for
identifying and contacting human subjects that may benefit from
participating in an action, procedure or study. When contacting the
human subjects that process may provide to the human subjects
information that is representative of the required grant of consent
that that human subjects will need to agree to in order to
participate in the action or procedure. The processes therefore
will allow the human subject to change consent stored in the data
memory. In the processes described herein the human subject may
change the consent stored in the data memory in response to a
request to change the consent, or, optionally, at their own
volition and unprompted. The human subject can change the consent
data in any manner that they choose, including expanding the
granted level of access and rights to the stored data, reducing the
granted level of access and rights, and eliminating altogether the
ability to access or use the data. Additionally, the user can
expand, restrict, or eliminate the types of parties that are
authorized to query the data that they have stored, or to recontact
them. For example, the human subject may restrict access to data to
only trusted intermediaries. Thus it will be understood to those of
ordinary skill in the art that the systems and methods described
herein provide a platform that offers the human subject a
substantial amount of flexibility in controlling how their data is
used and who can use it.
[0022] In a further aspect, the invention will be understood to
provide systems for managing access to medical record and genetic
information of an individual and to allow a researcher or clinician
or other biomedical professional to find participants for a study.
The systems may comprise a database that has storage for medical
record an biological data of an individual and that has storage for
consent data that is representative of a limited grant of informed
consent provided by the individual for the data. The database can
link the consent data with the stored medical record and biological
data. The systems further comprise a query tool that allows a
researcher to query the medical record data to identify an
individual of interest to the study and that returns to the
researcher the consent data that is associated with medical record
data that matches the query. The system further includes a contact
mechanism that can be a computer process, and that allows the
biomedical professional to indicate a required grant of consent for
the study and to contact the individual and request the individual
to grant the necessary informed consent. The system further
includes a response process that allows the individual to
participant in the study by granting the new consent and
associating the new consent with the data provided by the
individual.
[0023] Optionally, the systems may include data storage for
biological sample data, medical data and genetic data. Storage
systems for physical storage devices may be incorporated into the
systems as well. Thus, in some embodiments refrigeration storage
systems for storing samples, such as tissue samples, may be
integrated into the systems described herein. In one embodiment,
access to the sample storage systems may be controlled as well as
monitored by the systems described herein. To this end, these
systems may include access control devices that verify access
requests against a stored level of informed consent provided by the
human subject. The systems may further include a network web server
for providing access over a data network. In these embodiments, a
web server may be included to provide a portal that gives network
access to both researchers and individuals. The portal may a secure
website that requires a password and user name to log on to and
access. Thus the portal may provide a secure mechanism for allowing
authorized individuals to have easy access to the system for the
purpose of managing how their data is to be used. At the same time,
the web server may be employed as a portal to present information
to authorized user. Thus a biomedical professional may be
interested in conducting a study and, through querying the stored
data, may have identified a group of individuals that may benefit
from the study. The biomedical professionals may generate a
description of the study and the benefits that it may hold. At the
same time the biomedical professionals may create an appropriate
informed consent form. The biomedical professionals may deliver to
the system the description of the study and the required informed
consent form and the system may post the description and informed
consent form to each of the individuals identified by the
biomedical researcher. Thus in one embodiment, when an authorized
user logs on to the portal, they will be presented with a web page
that describes a study from which the database query indicates that
they may benefit. The web page may further include a link to the
required informed consent. At the discretion of the individual, the
individual may agree to join the study by granting the required
level of consent and having the required level of consent be
associated with their stored data. Optionally, the portal may
identify the targeted individuals that have granted the required
level of request and provide this information to the researcher. In
this way, the systems and methods described herein provide a facile
system for allowing a biomedical professional to enroll
participants into a study or procedure that they are
conducting.
DESCRIPTION OF THE FIGURES
[0024] The foregoing and other objects and advantages of the
invention will be appreciated more fully from the following further
description thereof, with reference to the accompanying drawings
wherein;
[0025] FIG. 1 depicts a first embodiment of a system according to
the invention.
[0026] FIG. 2A depicts a process of compiling together
study-specific (i) ICFs, and (ii) genetic education.
[0027] FIG. 2B depicts a process of compiling together
study-specific (i) ICFs, and (ii) genetic education.
[0028] FIG. 3 depicts a process of enrolling participants in a
clinical study.
[0029] FIGS. 4A and 4B depicts a process whereby a study
participant may manage some portion of his or her Informed Consent
forms.
[0030] FIG. 5 depicts a process for sample handling and
collection.
[0031] FIG. 6 depicts a process for managing sample genotype
data.
[0032] FIG. 7 depicts a process for managing the entry of
phenotypic data for study participants.
[0033] FIG. 8 illustrates an exemplary embodiment of the subject
system for use in managing the informed consent processes of a
genetic trial.
[0034] FIG. 9 depicts a process for managing requests for on-line
and off-line educational materials.
[0035] FIG. 10 depicts a process for providing a participant with
an ICF for signature.
[0036] FIGS. 11A-C depict a process for a participant withdrawing
from a study.
[0037] FIG. 12 depicts a process for managing hard copies of
executed ICFs.
[0038] FIG. 13 depicts a process for controlling access to new
sample management protocols.
DESCRIPTION OF CERTAIN ILLUSTRATED EMBODIMENTS
[0039] Federal and international regulations demand that all
individuals participating in clinical procedures, clinical trials
or other medical studies sign a formal document, known as the
"Informed Consent Form" (ICF). These documents must be signed after
the individuals have received (by their physicians as well as by
other study-related education specialists) sufficient information
to have a reasonable understanding of the non-technical study
aspects (e.g., scope, risks, future use of results, future use of
the personal and medical information provided by the study
participant, etc.). The ICF is to provide a succinct description of
these aspects. After signed by an individual, an ICF constitutes
formal evidence of the willful and informed decision of the
individual to be part of the study. Typically, although optionally
before a study participant at a given site can sign an ICF, an
Institutional Review Board (IRB) or Ethics Review Board (ERB) at
that site is to approve the study protocol and the ICF.
[0040] Obtaining informed consent specifically for the purpose of
donating DNA for large-scale sequencing may raise some unique
concerns. Because anonymity typically cannot be guaranteed and
confidentiality protections are not absolute, the disclosure
process to potential donors should clearly specify what the process
of DNA donation involves, what may make it different from other
types of research, and what the implications are of one's DNA
sequence information being a public scientific resource.
[0041] The systems and methods described herein provide a dynamic
process for obtaining and managing informed consent documentation.
In general, although not in all embodiments and practices, the
dynamic informed consent process (DICP) makes use of an
intermediary organization, e.g., a trusted intermediary, which: (a)
provides ICFs which may have been dynamically generated for a
specified trial or medical procedure and based on relevant study,
state and federal requirements, if any; and (b) archives copies of
signed ICFs. In certain embodiments, the processes provide training
materials, such as written, audio or video presentations, to be
reviewed by prospective participants. In certain embodiments, the
process also includes contacting subjects who have signed ICFs in
the event that there is a change of circumstance which the subject
may deem material to whether s/he would continue to consent, or to
recontact participants with a proposal to join another study or to
continue with a study as it progresses to a later stage.
[0042] An often common complication to any of the above examples of
instances which are suitable for use of the subject process is
that, because of local regulatory differences among geographic
locales, ICFs are to be tailored to the study participant's
location (state, country) as well as potentially having to be
translated in the participant's native language. To this end, and
as described later, the subject systems and processes may be used
to generate ICFs which account for such local variations in
requirement.
[0043] Once created, the subject informed consent process may also
be used to manage ICFs for clinical trials. For instance, the
systems and processes may be used to deliver information and obtain
verification from a prospective participant that s/he understands
that the trial is a scientific experiment and there may be risks
and dangers to their health and privacy that s/he has been told
about the reasons for doing the trial, the identity of the drugs
which may be given, the number of visits and the kinds of lab tests
required. Additionally and optionally, as different and various
types of data may be stored, generated or employed as part of the
clinical trial or procedure, including the genotypic data,
demographic data, identity data, medical history data and other
types of biological data, the ICF is likely to speak to the
entities and purposes that are allowed to employ this data. Thus,
in certain embodiments, the systems and methods described herein
may be used to manage the ICFs for human subjects providing access
to genotypic or other individually identifiable phenotypic
information, which may be an outcome of, for example, a clinical
trial, a diagnostic test, or a healthcare database. Likewise, the
subject method can be used to manage the ICFs for subjects
providing tissue or cells samples for research or diagnostic
purposes or for use in a cellular product.
[0044] In many instances of clinical trials or genetic testing,
ICFs are study-specific and cannot be modified. In these cases, if
a new study, Study B, has to be designed to expand on a previous
genetic study, Study A (e.g., because new findings indicate that it
makes sense to pursue a different avenue), then a new protocol must
be generated and approved and a new ICF must be generated and
signed by all the study participants. Thus, Study A participants
are to be re-contacted to ask their permission to use the material
collected during Study A for the new Study B. In the case of the
subject invention re-contacting is possible, either directly or, in
some embodiments, through a trusted intermediary, as the systems
and methods described herein have a link between study
participants, their data and, in some cases, their identity. Thus,
re-contacting is possible using the systems and methods of the
invention.
[0045] In still other embodiments, the systems and methods
described herein make it possible to dynamically generate ICFs.
Thus, the subject systems and methods may be used by a healthcare
provider to advise patients of current alternatives, e.g., it
updates the ICF to include any developments in management and
treatment that would be beneficial or detrimental or that could
cause them to choose another course of action. The subject methods
and systems can also be part of a patient management method which
includes recontacting former patients when new developments occur.
The term "duty to recontact" refers to the possible ethical and/or
legal obligation of medical or genetic service providers to
recontact or attempt to recontact former patients about advances in
research that might be relevant to them. Patients' knowledge of
advances in the molecular genetic bases of their disorders may have
great impact on their lives, affecting their psychological well
being, reproductive options, employment decisions, and lifestyle
choices such as marriage; in addition, there is a consensus in the
medical genetics community that patients should have access to
information about such advances. Such recontact of patients may be
triggered in the systems and methods described herein upon the
occurrence of such situations as (1) those in which a diagnosis had
been suspected, but not made, and a new diagnostic test has been
developed; (2) those in which a more accurate diagnostic and/or
prognostic test, postnatal or prenatal, has been developed (e.g.,
from linkage to mutation detection); and (3) those in which new
information may alter the prognosis or recurrence-risk
estimates.
[0046] From the perspective of a biomedical professional the
systems and methods described herein provide tools that allow for
easily identifying human subjects that may be appropriate for a
study or action and for contacting these subject with the requests
for the required consent. The invention therefore can also be seen
as tools that make it easier for a biomedical professional to
organize a study or other action.
[0047] The invention, in its various embodiments, recognizes and
addresses these and other problems and overcomes many limitations
encountered by those skilled in the art by bringing together, and
bridging the gaps that have existed between the legal, medical,
consumer and training fields with respect to establishing dynamic,
certifiable informed consent.
[0048] Those skilled in the art will appreciate that the subject
processes and systems can, but need not, be carried out in a fully
or semi-automated manner, e.g., utilizing computer systems to
generate the ICFs, archive the executed ICFs, and prompt for
recontact of a subject when necessary. For ease of reading, the
following description of exemplary embodiments is directed to the
utilization of computerized systems for at least certain aspects of
the subject process.
[0049] II. Exemplary Embodiment
[0050] FIG. 1 depicts a first embodiment of the system according to
the invention. Specifically, FIG. 1 depicts a system 10 that allows
a plurality of human subjects to control, optionally dynamically,
the consent that they grant for the use and access of their
medical, genetic and biological data. Additionally, as well be
explained in more detail below, the system 10 depicted in FIG. 1
provides a platform that allows a biomedical professional to easily
enroll participants into a study or other action. The system 10
depicted in FIG. 1 will now be explained in the context of a system
that allows individuals to control dynamically the consent they
grant over their data during a process in which the individuals
decide whether to enroll within a study being offered by a
biomedical professional. However, although FIG. 1 is merely
representative of one embodiment of the invention, an embodiment
that integrates a plurality of components into a single system. It
will be apparent to those of skill in the art that a single
integrated system is not required and that the different components
of the system may be kept separate from each other and operate a
different locations with communication occurring over a data
network or through some other methods.
[0051] In the embodiment of FIG. 1, the system 10 contemplates a
single integrated system of the type that may be maintained and
operated by a trusted third party. A trusted third party could
include a company, government agency organization or other entity
or entities that are familiar with the different relevant
legislative frameworks that control and regulate the distribution
of medical data, identity data, genetic data, and other types of
controlled data. Typically, the trusted third party would be an
entity that is also familiar with the rules and regulations that
control and regulate the requesting and granting of informed
consent. However, it will be apparent to those of skill in the art
that the systems and methods described herein may be employed in
other contexts, including contexts wherein there is no trusted
third party and the entity that is carrying out the enrollment
process is the biomedical professional themselves, or an
organization supporting the biomedical professionals, such as a
pharmaceutical corporation, a hospital, or some other type of
entity. However, for the purpose of clarity the system 10 will now
be described within the context of an enrollment process that
employs a trusted third party for brokering the exchange of a
request for consent and the delivery of consent between biomedical
professionals and individuals that have stored their data in a data
repository.
[0052] More particularly, FIG. 1 depicts a system 10 that includes
a query process 12, a database 14, a recontact process 18, a portal
process 20, a consent process 22, an enrollment request 24, a list
of enrolled participants 28 and a query 30. In a typical
embodiment, the different processes and the database 14 may be
realized as a data processing system comprising a computer program
and a computer server on which that program is executing.
Accordingly, each of the processes 12, 18, 20 and 22 depicted in
FIG. 1 may represent a single computer program that is running on a
computer server. Similarly, the depicted database 14 may represent
a database management system computer program and a non-volatile
storage device or other type of data memory capable of providing
long term storage of data. The query process 12 may be a SQL query
process of the type commonly employed for performing queries of
data stored within a database system.
[0053] More specifically, the depicted database 14 may be any
suitable database system, including the commercially available
Microsoft Access Database, and can be a local or distributed
database system. In this embodiment, where a trusted intermediary
is employed, the database 14 may be part of a genetic banking
system, such as the ENTRUST genetic banking system provided by
First Genetic Trust of Chicago Ill. Such a genetic banking system
can provide secure storage of a person's demographic, medical,
genetic, and biological data. As well as other information the
person chooses to store. As is described in the above referenced
U.S. application Ser. No. 09/939,200, Filed: Aug. 24, 2001, titled
METHOD FOR INDEXING AND STORING GENETIC DATA, the database 14 may
provide for secure storage of data such that patient identity
information is stored separately from patient medical data. As
described in the referenced application, each person storing data
in the database may be provided with a virtual private identity
(VPI) code that links the patient to their identity information.
This identity information may kept in a secure and encrypted
database. The VPI may also be used as a key into a second separate
database that contains inter alai, medical, genetic, biological and
sample data. Thus the VPI can act as a link between a person's
identity data and their medical data. By controlling the VPI so
that it can only be used by a entity authorized by the person
(typically by requiring the person to provide a private key to be
used with the VPI) the database 14 can allow access to the
patient's medical, genetic and biological data, without allowing
access to the patient's identity information.
[0054] Although the database systems described in the
above-identified reference may be employed with the system 10, it
will be understood that other database systems may be employed as
well. The design and development of suitable database systems are
described in McGovern et al., A Guide To Sybase and SQL Server,
Addison-Wesley (1993), the contents of which are incorporated by
reference. The database 14 can be supported by any suitable
persistent data memory, such as a hard disk drive, RAID system,
tape drive system, floppy diskette, or any other suitable system.
The system depicted in FIG. 1 includes a database device 14 that is
integrated with the system 10. However, it will be understood by
those of ordinary skill in the art that in other embodiments the
database device 14 can be separate from and even remotely located
from the system 10.
[0055] In either case, the system 10 includes within the database
14 a storage location for storing information that is
representative of the grant of consent provided by a person. This
grant of consent typically includes a grant of informed consent
that indicates the type of access and uses that may be made of the
person's information. Additionally, the consent data typically
includes a field to indicate whether the person has consented to
being re-contacted. Further and optionally, the grant of consent
may include data representative of restrictions put on the use of
the data by the person, where these restrictions or consents relate
to whether interested parties, such as researchers, clinicians,
pharmaceuticals companies, or others, can search their data or
contact the person. Similarly, the consent may include a
restriction on the manner in which a person may be re-contacted.
For example, the person may require all contacts to be made by a
trusted third party, and may require that the contact by sent by
e-mail to the person's physician. Thus, it can be seen that the
system 10 of the invention now provides the genetic baking system
with consent information that may be stored with the person's
medical, genetic and other data and that may indicate controls,
permissions and restrictions placed on the data by the user.
[0056] How the medical data and consent data get stored or
organized within the database 14 will depend upon the application
and any suitable technique may be employed. The organization of
data within the database system 14 will, typically, involve a set
of tables and fields that will organize the data into searchable
units. This table and field structure is described in the
above-cited McGovern reference.
[0057] With consent data now stored in the database 14, a query
process, such as the query process 14 may be provided that checks
with the consent data when performing searches for a bio-medical
professional--or an intermediary acting at the request of a
biomedical professional. The query process 12 can generate queries
that act on the tables and fields of the database 14 for the
purpose of being able to sort through data that is stored in the
database 14. The query process 12 also organizes data into search
results that will be returned as the response to the query 30.
Accordingly, an authorized biomedical professional that may have
logged onto the system 10 via a secure Internet session may submit
a query 30 to the query process 12, and the query process 12 can
analyze that query 30 and create an SQL compliant demand that may
be understood by the database 14. In a typical example, the query
30 submitted by the biomedical professional will be a request to
search through the data tables of database 14 to identify medical,
biological, genetic or phenotype data having certain
characteristics.
[0058] The query 30 may include other parameters as well including
demographic parameters and medical history parameters. In any case,
the query 30 submitted by the biomedical professional will be
processed by the query process 12. The query process 12 will
determine a set of SQL commands that may be used to identify the
set of data that satisfies the parameters outlined within the query
30. The depicted query process 12 will also review the consent data
associated with any information that meets the parameters of the
search query 30. To this end, in one embodiment, the query process
12 develops SQL commands that retrieve from the database 14 a set
of identifiers that represent individuals that have stored data
relevant to the query 30. The identifiers are often anonymous in
that they themselves lack identifying information--such as the VPIs
described above. The identifiers are returned for persons that have
stored data that meet the requirements of the query 30. The query
process 12 can then review the identified consent data and
determine which of the individuals have provided an associated
grant of consent with their data that indicates consent to be
re-contacted. The re-contact consent is often for the purpose of
receiving requests to change the grant of consent they earlier
provided. The query process 12 may then forward to the recontact
process 18 the list of individuals that meet the parameters set up
in the query 30 and that have agreed to be re-contacted.
[0059] As described above, the type of restrictions, permission and
access controls provided by the person within their consent data
may vary according to the application. Consequently, the query
process 12 may perform other operations. For example, in those
applications where people are allowed to restrict whether their
data or portions of their data can be searched, the query process
12 may perform an initial process that identifies which data
records or portions of data records stored in database 14 may be
processed. In other embodiments, where people are allowed to
restrict what types of entities can search their data, such as only
allowing trusted parties or bio-medical professionals associated
with research hospitals carrying out studies on a particular form
of cancer, the query process 12 may first do an initial sort of the
data records to identify data that is available for searching under
these parameters.
[0060] In an optional embodiment, the query process 12, or another
process, may also include an authorization process that requires a
biomedical professional to enter a user name and password into the
system. The user name and password can associate the biomedical
professional with the particular entity, or type of entity,
project, or type of research. In this embodiment, the query process
12 can employ information about the biomedical professional to
determine whether the biomedical professional has been granted the
right to search data within the database 14. In some embodiments,
the database 14 may be subdivided into different sections, with
certain sections of the database being available to biomedical
professionals of a particular type, such as academic researchers or
researchers conducting studies related to a particular type of
cancer. Thus in these embodiments, the query process 12 may limit
the application of query 30 to that data which has been authorized
to be searched by biomedical professionals of the identified
type.
[0061] In further optional embodiments, the query process 12 may
include a decryption process that can decrypt data that has been
stored in an encrypted format. For example, in one embodiment all
data stored in the database 14 is stored in an encrypted format.
The decryption process may employ a password based
encryption/decryption algorithm that can encrypt and decrypt stored
data as a function of a password employed by the database 14.
Processes for encrypting data can include simple XOR algorithms,
one-time pad based algorithms or more complex ciphers including any
of the algorithms or techniques described in Bruce Schneir, Applied
Crytpography (Addison-Wesley 1996), the contents of which is herein
incorporated by reference. Any of these processes may be carried
out by the query process 12, and other process shown in FIG. 1, to
allow these process to manipulate in clear text data that has been
stored in an encrypted format.
[0062] In either case, the depicted query process 12 can return a
list of individuals that have medical, genetic and other data that
meet the parameters of the query 30 and that have agreed to be
re-contacted. In one embodiment, the query process 12 provides the
search results to the bio-medical researcher. The search results in
one practice include the relevant medical data and the consent data
granted for the medical data. Depending upon the application, the
system 10 may default to a process that requires that each person
providing data be re-contacted with a request to execute a new
grant of consent. This is the process that is implemented by the
system 10 of FIG. 1. In an alternate practice, the system 10 may
allow the bio-medical professional, or some other entity to
determine which of the individuals are to be re-contacted. Other
practices may be employed depending upon the application at
hand.
[0063] In either case, the re-contact process will be invoked. In
the depicted embodiment, the re-contact process 18 responds to the
request of the query process 12 to recontact each of the identified
individuals. To this end, the recontact process 18 can obtain or
generate information that may be helpful to an individual that is
going to be recontacted with a request to change their granted
consent. In one embodiment, the recontact process 18 requests the
biomedical professional to provide a brief description of the
purpose of the study or other action being proposed. Additionally,
the recontact process 18, as will be described in greater detail
hereinafter, may require the biomedical professional to go through
an informed consent process that generates, by itself or as part of
a larger process, an appropriate and compliant informed consent
form that may be provided to the different individuals that are
going to be re-contacted. One process for generating such an
informed consent is shown in FIGS. 2A-7.
[0064] Once the recontact process 18 has the necessary information
to request the individuals to consider changing their grant of
consent, the process 18 can send a request to the portal process
20. In one embodiment, the portal process 20 includes an HTTP
compliant server process that provides a secure portal that allows
individuals storing data in database 14 to access an account
maintained used by the system 10. The portal process 20 notifies
the individuals of a request for them to consider joining a study,
procedure, or some other activity that requires the individual to
change the grant of informed consent.
[0065] In the depicted embodiment the portal process 20 accesses
the database 14 for each individual identified by the recontact
process 18. For each individual, the portal process 20 retrieves
from database 14 a patient code that may be employed for generating
an enrollment request page that will be served by the portal
process 20 to the respective individual when that individual next
logs onto the portal. Additionally, and optionally, the portal
process 20 may retrieve from the database 14 a contact data record
that provides some kind of addressing information so that the
portal process 20 may proactively notify the respective individuals
that there is a request for them to consider altering their grant
of informed consent. In one practice, the portal process 20
retrieves contact data that is representative of an email address.
The portal process 20 can then email to the individual a request
that they visit the secure portal site to view the information that
has been generated by the recontact process 18 and which will be
served by the portal process 20 once the individual accesses the
secure portal. Once the individual has accessed the portal, the
portal process 20 can present the enrollment request 24, which may
be a typical web page, to the individual. If the individual so
chooses, in this embodiment they may activate a link provided on
the enrollment request page that returns to the portal process 20
an indication that the individual has agreed to the change of
informed consent. To this end, the portal process 20 can activate a
consent process 22 that updates the granted informed consent
information stored for that individual within the database 14. The
processes for updating the informed consent data record can vary
and examples of such processes are depicted in FIGS. 9-13.
[0066] Thus, it will be understood that the portal process 20 can
also be understood as on example of a consent process that will be
employed by the system for allowing a person to change the grant of
consent provided with their data and stored in the database 14.
Other examples of consent processes are set out below with
reference to FIGS. 9-13.
[0067] In depicted embodiment, each time an individual changes
their consent within the database 14 the recontact process may be
notified. If the recontact process 18 determines that the
individual changing their consent is associated with the list
generated by query process 12, the recontact process 18 can
indicate that the individual has enrolled within the associated
study and, optionally after a set period of time, generate a web
page 28 of enrolled participants. The web page 28 may be served
over a secure connection to the associated biomedical
professional.
[0068] Accordingly, FIG. 1 depicts one exemplary system according
to the invention that allows individuals to agree to change the
grant of informed consent such that the individuals may participate
in a study or action that may be of benefit to them.
[0069] In the system 10, each time the biomedical professional
wants to re-contact a human subject, the biomedical professional
provides the system 10 with an informed consent form that the human
subject is to review and execute. The informed consent form (ICF)
may be manually prepared by the biomedical professional. However,
in certain alternative embodiments, the ICFs are created in an
automatic or a semi-automatic way. Typically, every action or study
has a number of predefined associated sites (in the case of
pharmacogenetic trials, the sites are the participating hospitals).
The system 10 can assemble and maintain a database of
regulation-compliant ICF templates for some or all possible sites.
When the protocol for the study has been finalized, the Manager of
the study requests the generation of appropriate ICFs for all
participating sites. As FIGS. 2A and 2B illustrate, this request
can start an automatic process which:
[0070] 1. Generates appropriate ICF templates for every
participating site (e.g., all such sites that have registered on
the DICP system during the process of setting up the study).
Appropriate sections of the templates can be automatically filled
by information extracted from corresponding sections of the study
protocol.
[0071] 2. Notifies the Protocol Manager of the study to fill in
those sections of the ICF templates which were not handled
automatically in the previous step.
[0072] 3. Forward the generated ICFs for internal review and then
for review, comments and IRB-approval to the appropriate contact
persons at the participating sites. The contact persons may get
back to the Protocol Manager with requests for modifications, made
by the IRB at the contact persons' sites.
[0073] Particularly, FIGS. 2A and 2B depict pictorially a process
for designing a study, such as the study of the efficacy of a
cancer drug, as well as a process for developing a protocol design
and study management. Thus, FIGS. 2A and 2B describe how a study
and protocol may be designed and managed and it will be understood
that the created study and protocol may be implemented by employing
the systems and methods described herein including the system 10
depicted in FIG. 1.
[0074] Turning to FIG. 2A, the major actors involved in study
design, power calculation, protocol design and management are
depicted. Specifically, FIG. 2A depicts a study design process 40
wherein a pharmaceutical trials manager 42, a clinical statistician
44, a pharmaceutical protocol manager 46, an internal review board
agent 48, and a hospital physician 50 come together and cooperate
to develop a study. As depicted in FIG. 2A, the pharmaceutical
trial manager 42 can help determine the type of lab information
that will need to be collected and databased for the study as well
as the different pharmacogenetic information that will have to be
collected and then stored as well. As shown in FIG. 40, the
pharmaceutical trial manager 42 can help develop the lab
information database 52 as well as the pharmacogenetic trial
database 54. In practice, legacy clinical trial databases may be
employed to help supplement or seed these databases. Information on
these databases can include trial information from past legacy
clinical trials and hospital contact information. Other information
may be stored in these databases 52 to 54 as well.
[0075] FIG. 2A further depicts the clinical statistician 44 may
contribute information to a type of bio-informatic database and may
help determine the type of information that needs to be stored in
this database 56. Additionally, the clinical statistician 44 may
help design the pharmacogenetic protocol database and master plan
tracking database 58 that will be employed during the study. As
further shown in FIG. 2A, the pharmaceutical protocol manager 46
may aid in the development of the pharmacogenetic protocol database
58 as well. The depicted hospital physician 50 may communicate with
the pharmaceutical trial manager 42 and may provide input to the
various databases including the pharmacogenetic database 54 and the
pharmacogenetic protocol database 58. Additionally, as shown in
FIG. 2A, the hospital physician 50 may participate in the protocol
approval process along with the internal review board agent 48. The
information collected during the study design can include
information regarding phenotype data management, sample collection
and management, genotyping management, genotype data storage and
management, as well as information about the dynamic informed
consent that will be necessary and information that may be employed
for dynamic informed consent creation. Thus the database can store
information about the required informed consent as well as
information that can help the system 10, optionally, dynamically
generate the informed consent that will be provided to human
subjects.
[0076] FIG. 2B depicts pictorially the kinds of information that
may, representatively, be employed during the dynamic informed
consent creation process. Specifically, FIG. 2B depicts a process
60 that shows different factors considered during the dynamic
informed consent creation process. These factors can include the
type of information normally provided by an informed consent form,
specific informed consent information for the clinical site as well
as protocol informed consent information for the clinical trial and
templates of informed consent forms that comply with state, local,
and federal guidelines and regulations. FIG. 2B further depicts
that optionally genetic education material may be provided as part
of the dynamic informed consent. Additionally, genetic education
material that is relevant to the clinical site as well as the
clinical trial protocol and different state, local, and federal
regulations may also be part of the process that dynamically
generates the informed consent form.
[0077] Optionally, other educational material may be assembled
together with the IC form. This can be a content-building process,
where both on-line and off-line educational material for a specific
study is compiled. Off-line educational material can include books,
videos, CDs etc. As in the compilation of the IC forms, there are
multi-language issues and educational templates that are specific
to individual locales and study. Further, each Human Subject may
include with their demographic data a preference of language
selection. This preference of language selection may be employed by
the ICF process to generate a form and select templates written in
the selected language. FIG. 9 depicts one process for providing
educational materials to the Human Subject. The language of the
educational materials may similarly be selected according to data
stored in association with the person receiving the educational
material.
[0078] As shown in FIG. 3B, the enrollment of an individual X in a
study can be performed by an authorized Person Y (usually a
Physician participating in the study). In particular, FIG. 3B
depicts a study participant enrollment process 70. In particular,
FIG. 3 depicts pictorially that a study participant may provide
demographic information and may complete the necessary informed
consent to register for the process. Optionally, a physician 74 may
look at the demographic information as well as various screening
criteria to determine whether the study participant should be
enrolled in the process. The screening criteria as well as the
trial registration process may be performed according to the study
design and protocol design and management guidelines 76 that were
developed during the process 40 depicted in FIG. 2A. FIG. 3 further
depicts that the informed consent 78 provided by the study
participant 72 may be, in some optional embodiments, provided
electronically by the study participant 72 employing a digital
signature to execute the dynamically generated informed consent
form. In the process 70 of FIG. 3 a virtual private index
identification code is provided to the study participant 72. This
code may be employed by the study participant to allow the study
participant to provide medical, biological, genetic or phenotypic
data to the study but do so using the VPI so that providing the
information is done anonymously. The VPI provided to the study
participant 72 may be employed by the study participant 72 to
monitor the study and the optionally receive information from the
physician 74 conducting the study. One technique for generating VPI
codes is described in the above referenced U.S. Patent Application
entitled METHOD FOR INDEXING AND STORING GENETIC DATA.
[0079] The exemplary enrollment process may involve the following
steps:
[0080] 1. Screening: the authorized Person Y performing the
enrollment should confirm that the potential Study Participant X
meets the requirements for being part of the study. To do so, Y may
log onto the DICP system and get access to that part of the
protocol of the study that defines the inclusion/exclusion
requirements that study participants are to meet.
[0081] 2. Registration/Certification: If X is not already in the
database, then Y may register X with DICP. This step involves, for
example, entering the personal information of X into the system,
and requesting credentials for X (such as user Id and password
or/and the creation of a digital certificate). The outcome of this
step is to make X a "registered person" in the DICP system.
[0082] 3. Account Creation/Update: If X has never before
participated in a DICP study, a new Login Account can be created;
otherwise, his or her existing Account is used. The Login Account
is updated with the addition of an entry for the study at hand.
This entry is automatically populated with links to on-line
educational material for the instant study, links to the on-line
informed consent documents, etc.
[0083] There are a number of occasions where it may be advantageous
to permit a Study Participant to manage at least a portion of his
of her informed consent process. FIGS. 4A illustrates certain
embodiments whereby the Study Participant participates in managing
at least a portion of the process involved in complying with
informed consent requirements for a study.
[0084] In general, before participation in a study begins, a Study
Participant must sign the appropriate ICF or ICFs for the study,
e.g., after receiving the appropriate study-specific
education/counseling. In the illustrated embodiments, at the time
of the Participant's enrollment, on-line educational material and
on-line ICFs are linked to the Participant's Account (as part of
the Account entry created for the study at hand). In such
embodiments, the subject system may include an educational material
system that allows an account holder (or an authorized user
typically a study participant or prospective participant) to gain
access to educational material both on-line as well as by physical
delivery of offline educational materials for any of the studies he
is participating in. The physical delivery can be, e.g., by mail or
may be outsourced to a third party vendor. In certain embodiments
Study Participants (or authorized Proxies) may also be able to
access on-line or off-line counseling through their account, such
as genetic counseling.
[0085] Accordingly, FIG. 5 depicts pictorially a process 100
wherein a study participant that is provided by an identity code,
in this case, a virtual private identity (VPI ) code, provides
biological, genetic, or some other sample data to the study. The
process 100 provides a sample collection and management protocol
process that allows samples to be collected, temporarily stored,
and shipped. The protocol further provides for sample receiving and
storage, sample processing, sample tracking, and DNA and protein
shipping. The different steps in the sample collection and
management can be carried out in accordance with the protocol. The
set up for these processes is set out by the protocol registration.
In the process 100 depicted in FIG. 5 the study participant may
give informed consent to the use of their sample data. However,
once the data has been sampled and stored and information about
that sample has been stored in the database 14, the data are, if
authorized, available to consider for use in subsequent studies.
Accordingly, the system 10 depicted in FIG. 1 provides a DICP
system that a biomedical professional may employ for contacting
enrolled participants and distributing to them new informed consent
forms that follow the guidelines and requirements set up for the
proposed study and provide the necessary level of consent or grant
of consent to conduct the study. Thus, in this example, samples
that were originally were provided by the study participant for one
particular sample of processing procedure may subsequently be of
interest to a biomedical professional for another study. In this
situation, the study participant 102 may be recontacted by the DICP
system 10 with a new informed consent form and a request that the
study participant 102 execute that form so that the storage sample
may be employed.
[0086] Whether the ICF is generated dynamically or not, the ICF is
delivered and signing of the ICF can be performed either on-line or
off-line. As FIG. 12 shows, in certain embodiments, the Participant
can print out a copy of the ICF, sign the document, and return the
signed document to the DICP system 10. In certain preferred
embodiments, an image of at least the signature page(s) is captured
and the audit trail for that Participant is updated. To facilitate
tracking of such documents, a bar code can be generated on the
documents at the time they are printed. Upon imaging the documents,
the bar code can than be used to link the image, or an OCR thereof,
with the Account Holder.
[0087] In certain instances, a study participant may decide to
withdraw from a study and request that all the samples taken from
him or her in the context of that study be destroyed and all
information connecting the Participant to the study erased from
DICP system 10. This function allows study participants enrolled in
a pharmacogenetic study, as an illustration, to withdraw from the
study and request the destruction of all the samples and data taken
from him or her in the context of this study. Because study
participants may withdraw at various points of a study, there are
different dependencies and actions that may occur. Also, the fact
that a user withdrawing from one study does not mean he or she is
withdrawing from all studies or withdrawing from the DICP system
10. FIGS. 11A, B and C show an exemplary mechanism by which the
system can achieve such a withdrawal.
[0088] After the study participant has indicated withdrawal from a
particular study, the system 10 operates as an ICF manager that may
confirm that the participant does indeed want to withdraw. Upon
confirmation, the ICF manager will initiate the steps of
withdrawal, which optionally includes destruction of the patient's
samples and information related to the specific study.
[0089] The system 10 has been described as part of an enrollment
process for identifying and enrolling human subjects into a study,
action or procedure. However, the system 10 may also be seen to
provide a system that dynamically creates and/or distributes ICF
forms for participants registered with the system 10. Such a
dynamic system, that can determine whether there is
authorization/consent provided to recontact the human subject and,
if authorized, recontact the human subject to get a new grant of
informed consent, may be employed in many other applications. For
example, FIG. 5 illustrates a sample collection and management
protocol. In certain embodiments, the subject DICP 10 system may
include a component which provides centralized management,
tracking, and auditing of samples obtained from Study Participants,
e.g., tissue or cells samples, nucleic acid sequences or the like,
and the protocols applied to them. In many instances, such samples
may be stored at remote, third-party sample labs. In such
instances, the subject DICP system 10 can be used to track
operations and events relative to each sample.
[0090] Thus will be seen from the above description that the
systems and methods described herein include systems that can
optionally dynamically generate an informed consent form that may
be employed by the system 10 to enroll a human subject as a
participant in a study, action, or other procedure. This process,
as described above and as depicted in FIG. 4B, may be realized as a
computer program operating on a computer server. As shown in FIG.
4B, the process may include a first step 90 wherein a protocol and
study are developed. As described above the development of the
protocol and study may be done according to conventional processes
that consider the information that needs to be collected before the
study, the type of patients that need to be enrolled in the study,
the types of protocol that need to be in place for managing
information, data, samples, and other elements of the study and
review procedures that are to be followed while conducting the
study, working with human subjects, and during later data
analysis.
[0091] As shown in FIG. 4B the process may then move to step 92
wherein the process 90 may create an informed consent form. In step
92 the process 90 may create a template that includes in the
template the kind of information that is to be provided to a
subject to satisfy informed consent requirements set out by the
clinical site, the clinical trial protocol, state, local and
federal regulations, and any other criteria that need to be
considered under the developed protocol and study. Optionally, the
template generated may be an XML form that may include identified
fields that contain information that is to be presented to the
human subject and fields that are to completed by the human
subject. Fields provided by the human subject may include fields
that indicate the type of informed consent being provided by the
human subject. For example, the informed consent form may be an XML
page that may include fields that may be included by the human
subject to indicate whether or not they are willing to be
recontacted, what type of researcher, clinician, or entity may
recontact them, whether their information and data stored within
the database 14 may be viewed, queried, or otherwise employed by
interested parties conducting different kinds of research. What
kinds of studies they are willing to be contacted about, for
example studies related to treatment of cancer, infertility, aids,
or some other kind of study.
[0092] After step 92 the process may proceed to optional step 94.
In optional step 94 the process may create educational materials
such as educational materials about genetic education, the disease
being treated, or some other relevant educational material. The
educational material selected may be chosen to comply with the
study protocol and design and to comply with educational
requirements set out by the clinical site, the clinical trial
protocol, or vary state, local or federal regulations. Other types
of educational material may also be provided as part of the
informed consent procedure.
[0093] After step 94 the process proceeds to step 96. Step 96 is an
optional process wherein language translations of the informed
consent forms may be generated. Thus informed consent forms may be
translated form Spanish to English, from English to Japanese, or
into some other language that may relevant to the pool of
perspective participants. The translation of the forms may occur in
part or in whole by automatic translation processes. Such automatic
translation processes are known in the art and any suitable
automatic translation process may be practice with the invention
described herein. In particular, automatic translation processes
may be employed for processing headings, titles, and instructions
that appear within the informed consent form. Optionally, the
content provided on the form may be translated by a human
translator and entered into the database separately.
[0094] When translations are created the process may proceed to
step 98 wherein the developed informed consent form is tested
against the protocols earlier designed and developed. This step may
be an interim step that forwards the generated form to a internal
review board or other relevant authority that reviews the form for
compliance with the protocols, regulations, and objectives earlier
set out. Once the form is approved the process may proceed to step
99 wherein the approved informed consent form is provided to the
system 10 depicted in FIG. 1 for subsequent delivery to the
appropriate human subjects.
[0095] In preferred embodiments, the system 10 is understood as a
DCIP system that can also provide support for all the steps that
comprise the life cycle of a sample. For instance, the DICP system
10 can be used to track sample acquisition. For instance, to take a
sample, an appropriate "sampling protocol" will often be followed.
The sampling protocol (e.g., which is part of the study protocol)
describes such steps and requirements as (i) how much sample needs
to be taken, (ii) how the sample taken needs to be aliquoted (e.g.,
how many sub-samples should be obtained from the master sample),
(iii) procedures for temporary storage of the sample, (iv)
procedures for shipping the sample to its final storage
destination, etc. When visiting a sampling facility, a Study
Participant uses DICP-issued credentials to instruct the sampling
facility of the sampling protocol that must be used for that
Participant.
[0096] To further illustrate, storing a sample may require
following the appropriate "sample storage protocol" which defines
sample pre-storage handling procedures and appropriate storage
conditions (the storage protocol is also part of the larger, study
protocol). This protocol is made available to the sample storage
facility. For tracking purposes, a sample can be bar-coded or
otherwise marked with a study-related Sample Id (SID) as well as
with a Sample Lab Id (SLID). SIDs are defined in the study protocol
and are the means of identifying samples for study purposes. SLIDs
are examples of a mechanism that the sample storage facility can
use for tracking inventory. In the illustrated example, the link
between SID and SLID must be made known to the DICP system 10, in
order to allow for appropriate sample tracking.
[0097] Samples can be retrieved for a number of reasons, e.g., in
order to be sent to a genotyping lab for further processing or in
order to be destroyed as the result of a Study Participant's
decision to withdraw from the study. In such cases, the procedure
to be followed for the retrieval is described as part of the study
protocol and should be made available to the sample storage
facility.
[0098] In certain embodiments, the DICP system 10 compiles and
maintains a database of "Sampling Labs" and "Sample Storage Labs".
Every entry in this database contains information about the
capabilities of that Lab, e.g., which sampling/storage protocols
that facility supports. See, for example, FIG. 13. The contents of
this database can allow the designer(s) of a study to make educated
selection of the sites that will participate in the study, based on
the availability of close-by Labs that can support the needs of the
study.
[0099] FIGS. 6 and 7 depict further processes that may benefit from
the systems and methods described herein. In particular, FIGS. 6
and 7 depict respectively a process 110 for genotyping management
and a process 120 for phenotype acquisition and management.
[0100] FIG. 6 illustrates an exemplary embodiment of a genotyping
management protocol for the subject DICP system 10. Genotyping of
samples will often take place in genotyping labs. Upon the
initiation of a genotyping request, the appropriate samples are
retrieved from their corresponding sample storage facility and
shipped to the genotyping lab. Upon receipt, the genotyping lab is
to proceed by following the "genotyping protocol" which is part of
the study protocol and defines the sequence of actions to be
performed. The genotyping lab gets access to the appropriate
genotyping protocol through the barcodes (or numeric ids) on the
received samples. The results of genotyping process are reported
back to the DICP system 10, after going through a "format
conversion" component, if necessary, that translates them to the
appropriate DICP-compliant data format. Similar to the Sampling Lab
case described above, the DICP system 10 can compile and maintain a
database of genotyping labs.
[0101] In certain embodiments, the subject DICP system 10 will
include a Phenotype Acquisition & Management protocol. As
illustrated in FIG. 7, such a sub-system allows the entry of
phenotypic data for the Study Participants. The type of data to
follow and report, are defined in the study protocol. The
collection of all that data can be considered the "study-specific
medical record" (SSMR) of the Study Participant. The DICP system 10
can provide a "Universal Medical Record Model" (UMRM), e.g., in
accordance with existing standards, which can describe various
phenotypic traits. For each trait, the UMRM can contain information
like (i) the trait name (e.g. "Blood Pressure"), (ii) the
associated value type (e.g., "numeric"), (iii) permissible ranges
(E.g., "Positive, less than 40"), etc. The SSMR can be defined (on
a study basis) as the appropriate subset of the UMRM.
[0102] Updating the SSMR of a Study Participant, is typically only
allowed to be done by authorized Persons (e.g. a physician) that
have appropriate Proxy rights on the Study Participant's
account.
[0103] FIG. 8 illustrates an exemplary embodiment of the subject
system for use in managing the informed consent processes of a
genetic trial and where there is a DICP supported phenotypic
database 146 and a DICP supported genotypic database 148. These
databases 146 and 148 may be generated according to the processes
described with reference to FIGS. 6 and 7. It will be apparent to
those of skill in the art that a DICP supported sample database may
also be provided, as well as databases containing other types of
data. Thus, in the embodiment of FIG. 8 it can be seen that
different components of a computer supported study or action may
include or use the DICP systems described herein. In this
embodiment, the informed consent 142 is linked, via the trusted
intermediary, with genotypic and/or phenotypic data derived for the
patient. In the process of obtaining the consent of the patient to
the use of such data, certain embodiments of the subject system 140
can be set up to obtain varying levels of consent from the patient,
e.g., which may effect to whom access is given and how a certain
portion of the patient's data may be used. For instance, the DCIP
system 140 can provide a controlled interface to the databases for
bioinformatics analysis. The bioinformatics tools 150 can be
provided as part of the DCIP system 140, or can be that of a third
party on whose behalf consent for such analysis has been obtained
from the patient. Such components/interfaces of the system 140 can
provide advanced tools and algorithms for analyzing and correlating
genotypic and phenotypic data.
[0104] The invention now being generally described, it will be more
readily understood by reference to the following examples which are
included merely for purposes of illustration of certain aspects and
embodiments of the present invention, and are not intended to limit
the invention.
EXAMPLE 1
Receiving and Signing of Informed Consent Form
[0105] A. Use Case Diagram
[0106] This use case allows the study participant to access the
Informed Consent Form (ICF) and Questionnaire online or by postal
mail.
[0107] Study participant receives the ICF and Questionnaire by mail
if desired. He must sign and mail the ICF and questionnaire back to
DICP. This can be done online by pressing "I Accept" button and
filling the questionnaire online. A notification for signing an ICF
for a particular study is posted in the message box of the Study
participant's page on the portal.
[0108] For the ICF to be valid, it has to returned and signed
before its expiration date.
[0109] While requesting ICF by postal mail, study participant can
specify if he wants to receive educational material along with
ICF.
[0110] Questionnaire is optional and part of the ICF. Filling the
questionnaire is not mandatory.
[0111] B. Basic Flow
1 Participant Action System Response 1. Potential Participant logs
2. System displays a pending request into the Study Participant for
signing the Informed Consent Form portal. along with the ICF
expiration date for the study he's participating in. 3. Participant
clicks on the 4. System displays a screen with three notification
message for options: signing ICF. a. Generate a printable ICF b.
Receive ICF by Mail c. Sign On-line When actor selects any of the
above options a barcode specific to the actor and study for which
he is signing ICF is generated by the system. This barcode along
with it's corresponding human readable number will appear on the
top of all the pages of ICF and questionnaire.
[0112] C. Generating a Printable ICF
2 Participant Action System Response Participant selects System
generates a read-only PDF "Generate Printable ICF" file of the ICF
and questionnaire which can be downloaded and printed. System also
displays message explaining downloading and configuration
instructions for Acrobat Reader for reading and printing PDF files.
System is notified that an ICF has been printed and ICF responding
workflow is invoked. Scavenger will check on all ICF's that have
not been received yet. The generated PDF file also has the return
address of DICP where the form needs to be submitted. Participant
displays the PDF file generated in the Step 2. Participant can
print the file or save it on his local system for later printing.
After signing the ICF he mails it to the DICP.
[0113] D. Receiving ICF/Educational Material by Mail
3 Participant Action System Response Participant selects System
retrieves the mailing address from "Receive ICF by Mail" the
actor's record and displays for option in the step 4. confirmation.
Participant has an option to edit the mailing address. This address
is not updated in his system record. System checks if this is first
time, Participant is given an option of receiving the educational
material along with ICF. Participant has a choice of System checks
for the validity of the saying, "Yes" to receiving address
specified by the Participant. If offline educational material.
incorrect, a corresponding error message is Presses the "Submit"
displayed with an option to update. button. Otherwise a request to
third party vendor for mailing the ICF form/Educational material
(if relevant) is triggered. Participant receives the
ICF/Questionnaire and Educational material by mail. Participant
fills in the questionnaire signs ICF and mails it back to DICP.
[0114] E. Signing ICF On-line
4 Participant Action System Response Participant selects "Sign
System displays the questionnaire, which On-line" needs to be
filled by the Participant. Questionnaire is optional component of
ICF. Participant optionally fills System displays the ICF form with
the "I in the questionnaire and Agree" and "I Don't Agree" buttons.
presses submit button. Participant presses the "I System displays
confirmation box and if Agree" button. actor accepts that an
acknowledgement page is displayed. The corresponding "Acceptance"
workflow is triggered. Participant presses the "I System displays
confirmation box and if Don't Agree" button. actor confirms to
disagree an appropriate message is displayed. The "Dissent"
workflow is triggered.
[0115] F. Alternate Flow: System Has Returned an Invalid Address
Message Against What the Actor Entered
5 Participant Action System Response System will generate a message
to the actor that the address they have entered does not match with
the address on file
[0116] G. Alternate Flow: Participant Requests Only ICF by Mail
6 Participant Action System Response Participant edits the address
System checks for the validity of the and presses the "Submit"
address specified by the actor. If incorrect, button. a
corresponding error message is displayed with an option to update.
Otherwise a request to third party vendor for mailing the ICF form
Participant receives the ICF/ Questionnaire by mail. Participant
fills in the questionnaire signs ICF and mails it back to DICP.
[0117] The processes described above pictorially can be engineered
as computer process running on a computer server. For example, FIG.
9 depicts one process 200 that may be representative of a computer
process running on a computer server and being capable of providing
educational material to a study participant or prospective study
participant. As shown in FIG. 9 the process 200 begins a step 202
wherein it proceeds to step 204 wherein the actor selects the study
and then selects the educational material that they wish to view or
have to view. In step 206 the system displays the materials to the
actor and in step 208 the actor selects additional desired
educational material. The request for material is reviewed in
decision block 210 wherein if the information is online the process
200 in steps 212 and 214 displays the online information to the
actor and the actor can review it and the process can end at step
216. Alternatively, if during decision block 210 it is determined
that the material is not online, the process 210 can proceed to
step 218 and 220. Wherein the offline material is available and can
be sent through the process beginning at step 222 or the message in
step 220 can be broadcast typically indicating that the information
is no longer available.
[0118] However, if in step 218 the materials are determined to be
offline and available the process 200 can proceed to decision block
222. In decision block 222 the process can determine whether or not
the study participant has already reviewed all the material that
they can receive offline, if yes, they can be told so in step 240.
Alternatively, if no, the actor may be provided with three options.
These three options are set out in decision blocks 225, 226 and
227. Typically, to maintain anonymity for the prospective study
participant the process can choose to mail the information to the
physician's address. Alternatively, the subject can choose to have
the information mailed to their own address in a file or can have
the information sent to an alternative address. In either case the
process in step 228 confirms that the mailing address is correct
and once that information is concerned the process proceeds to
steps 229, 230, 231 and 232 wherein the submission request is
reviewed, confirmed, recorded and noted for the purposes of
validating the conformed consent procedure. However, if the step
228 determines that the mailing address is incorrect then the
process provides several steps 234, 235 and 236, wherein the
prospective study participant can amend the mailing address.
[0119] FIG. 10 depicts a computer process 250 for having an
informed consent form be executed, or signed, by the human subject
and returned to the system. Specifically the process 250 begins
with the steps 252, 254, 256 and 258 wherein the process determines
that the participant needs to sign a informed consent form, allows
the participant to navigate to the informed consent form for the
selected study and allows the system to choose the informed consent
form based on the study and location that is relevant to the
participant. If the form is online then in step 260 the process
transfers the steps 262, 264 and 266 wherein the online form is
presented to the participant. In the depicted process the form is
provided with a "click wrap" agreement that allows the user to
execute the agreement by clicking a button "I agree". In
alternative practices different kinds of execution may be employed
such as digital signatures, biometric identity verifications and
authorizations and other similar types of processes.
[0120] Once the form is executed the process 250 can record the
updated grant of consent and the process may end at step 270. At
the decision block 260 however, it may be determined that the
informed consent form necessary is not online, in this case the
process can proceed to step 272 wherein the participant prints out
the ICF and the questionnaire and the system understand that the
form has been printed out and the patient in step 276 signs and
completes the ICF and the questionnaire and mails the ICF and
questionnaire back to the biomedical professional, a trusted third
party, or some other identity. In step 280 an offline process may
be employed for entering the form into the database 14 of the
system. As further shown in FIG. 10, the process may include a step
282 wherein there is a requested mailing. If this is the first time
that something has been mailed then it may be determined that the
documents may be mailed to the human subject. Alternatively, in
steps 290, 292 and 294 the participant may be prompt to receive a
mailing of educational materials. If they accept the educational
materials then again the process will capture the mailing address
and mail off the educational materials along with the informed
consent form and the questionnaire to the participant. In
alternative embodiments where educational material have to be
either sent and/or reviewed by the participant, there may be no
option step for the user to only receive the informed consent form
and the questionnaire and instead will have to receive the
educational materials as well.
[0121] FIGS. 11A, 11B and 11C depict processes for allowing a study
participant to withdraw from a study, an action, or a procedure. It
will be understood that the processes depicted in FIGS. 11A through
11C are representative of processes that the invention provides to
allow a user to change the grant of consent they have provided. In
the processes described hereinafter, the study participant chooses
to withdraw or eliminate their grant of consent. However, in other
processes the study participant may choose to expand, reduce, or
otherwise change the grant of the consent that they had provided.
Accordingly, it will be understood that the processes described
below are merely representative of the types of processes that may
be provided by the invention and variation to these example
processes will be apparent to those with ordinary skill in the
art.
[0122] Turning to FIG. 11A, a process 300 is depicted that begins
in a step 302 and proceeds to step 304. At step 304 the process 300
determines whether the user is logged in. If the user is logged in,
the process proceeds to step 306. At step 306, the system displays
a main study participant portal screen. The portal screen may be
understood to be a webpage provided by the system to the user for
the purpose of presenting the study participant with information
that is relevant to the managing of the participants talent. The
portal may be a web portal of the kind provided to allow for
authorized access to different services and information supported
by the portal. To this end, in one embodiment, the portal may be
realized as a secure web server capable of transferring HTTP
compliant data across a data network. The design and development of
such portals is known to those with skill in the art and any
suitable portal may be practiced with the present invention without
departing from the scope thereof.
[0123] As further shown in FIG. 11A, the study participant may
employ the portal in step 308 to navigate to the personal account
information maintained by that participant. The portal employed in
308 may be similar to the portal provided by portal process 20
depicted in FIG. 1. In step 310, the system displays the specific
studies that the participant has registered in. In the particular
practice depicted by FIG. 11A, the user is provided a virtual
private identity code that may be employed by the system has an
index key into a database that stores information associated with
that key and therefore that user. The virtual private identity key
may be kept secret by the user, thereby providing a level of
security to the database that stores information about that user.
In step 312, the user may select a pharmacogenetic study of
interest. The system then may display the selected pharmacogenetic
study information and link to the appropriate informed consent
form. In step 318, the user chooses to withdraw from a study. After
that, the process can proceed to step 320 wherein the system
displays action consequences and confirms the actions of the study
participants. If in step 322 the user verifies their request to
withdraw, then the process may proceed to process 350 depicted in
FIG. 11B. Alternatively, if the user chooses not to withdraw, then
the process may proceed from step 322 to step 314.
[0124] However, upon an indication of a request to withdraw, the
process 350 depicted in FIG. 11B may be invoked. In process 350 the
study participant is displayed, in step 352, contact information.
At decision block 354, the user can verify that contact information
and correct it if necessary. In step 356, the system can update an
audit trail. The audit trail will be representative of the actions
taken by the study participant through the portal site. In step
358, the system can assign an action id in a workflow system and in
step 360, the system can determine the appropriate manager of the
study and notify him of the withdrawal. In step 362, the system can
display a request that has been submitted (and other instructions
as well). After step 362, the process may proceed to process 390
depicted in FIG. 11C. Returning to decision block 354, if the user
wishes to update their contact information, the process at 354 may
proceed to step 364. The process in subsequent steps 368, 370 and
372 may choose to update and confirm their change of system address
information. In decision blocks 374 and 376, the process can
require a verification step to allow the address change to occur.
If verified, the address can be changed. If not, the system can
cancel the process. The saving of the information is depicted in
step 382 shown in FIG. 11B.
[0125] Turning to FIG. 11C, the process 390 is depicted as showing
step 392 where it is determined whether the user is logged in.
Between 392 and 398, the determination is made and the process 390
proceeds to 393. At 393, the system displays the main informed
consent form manager screen. The process 390 may then proceed to
step 394 wherein the system displays a pending informed consent
form. In step 395, the informed consent form manager can select
notification messages from a list and in step 396 the system can
display the withdrawal request and contact information provided
from study participant. At step 397, for each pending unsubscribed
action, the informed consent form manager contacts the study
participant vis a vis a telephone to verify the validity of the
action. If the action is invalid, the process at step 399 proceeds
to steps 400 and 402 wherein the ICF manager removes the
unsubscribed action and amends the audit trail. Alternatively, if
the action is not invalid, and therefore valid, the process
proceeds to steps 404, 406, 408 and 410 wherein the system
activates an unsubscribed process, that notifies all related
parties of the action, and there is a successful destruction of
data step 408. In step 410, the system generates notification to
the participant indicating that they have been withdrawn and that
their data has been destroyed.
[0126] FIG. 12 depicts a process that the systems and methods
described herein may employ for receiving a hard copy of the signed
informed consent form from a prospective study participant. In
particular, FIG. 12 depicts a process 420 that begins at step 422.
The process proceeds to step 424 wherein the person, in this case
the prospective study participant or study participant that is
interested in changing, including expanding or reducing the grant
of consent that they earlier provided, receives a document from
either the group running the study or from a trusted intermediary.
In step 426 the person can execute the document typically by
signing it and dating it and sends it back to the appropriate
authority. In the process 420 the appropriate authority may be the
trusted intermediary party or may be some other party such as the
clinical site where the study participant will give samples or
other information.
[0127] In step 428 the authorized entity receives the form and in
step 430 logs the form into the system 10. And in step 432
indicates that the form has been entered into the system. The
process 420 then proceeds to step 434 wherein a representative
reviews the documents for signature. At decision block 436 the
process determines whether the persons signature is accepted. If it
is accepted the process then checks in step 438 whether the witness
signature is accepted. The option of using a witness may be
available in some practices of the invention however it is not
always required. If the signatures are accepted the process
proceeds to step 440 wherein an authority scans the document image
into the document database based on a barcode provided with the
informed consent form. At step 442 the process determines whether
consent has been granted. This step can involve verifying other
kinds of criteria to consent such as has the form been completed
and returned within the appropriate time frame, has the form been
sent in duplicate, and other kinds of criteria. If the answer is
yes then the process 420 can proceed to step 444 wherein a
representative at the entity activates the document consent record
and reports questionnaire results if this are required. The process
then proceeds to step 446 wherein the system updates the audit
trail and workflow. If at the decision block 436 it is determined
that the persons signature is not accepted then the process may
proceed to steps 448 and 450 wherein a representative reviews the
remainder of the document for other errors and the representative
send the person a new document requesting their signature.
Optionally, the new form may be accompanied by a cover letter than
outlines the errors that arose in the original document.
[0128] Turning now to FIG. 13 a further process that may be
employed by the system depicted in FIG. 1 is depicted.
Specifically, FIG. 13 depicts a process 470 that controls the
access of new samples being managed according to the selected
protocol. The process 470 includes a step of entering the sample
management protocol into the system 10 and activating workflow. At
step 474 the sample lab manager may be notified that a new sample
management protocol has been put in their queue for review. The
sample lab manager, at step 476 may access the system 10 and be
sent the new sample management protocol into their queue via
workflow notification. The sample manager accesses their queue of
sample management protocols and in 479 the sample lab manager
selects the new sample management protocol to review from the list
provided. At step 450 the system displays a sample management
protocols and in step 452 the user reviews protocol for visibility
and translates the sample management protocol into their internal
system.
[0129] After step 452 the process may proceed to process 454
wherein the system prompts the user to confirm that the lab is able
to meet the requirements and confirm that the lab is not able to
complete the requirement or to identify the fact that they will
confirm this information later. At decision block 456 the user
validates that the lab can meet the requirements. In step 458 the
user inputs comments regarding their ascent and in steps 460-464
the system records that the sample lab can execute the requested
protocol sends a notice to the system, if such notice is dictated
by business rules and personnel then attend to offline activity.
Alternatively, if act decision block 456 the process determines
that the lab can not meet the certain requirements set out the
process proceeds to step 468 wherein the user validates that the
lab can not meet the requirement. If such validation occurs then
the process in steps 469-472 inputs comments regarding the descent
records that the sample can not execute the requested protocol and
the system sends a record to the appropriate personnel if such a
notice or record is dictated by business rules. Alternatively, if
at step 468 the user can not confirm that the requirements can not
be met the system proceeds to step 473 wherein they indicate that
at a later time the user will select to ascent or decline.
[0130] As discussed above, the dynamic informed consent process and
systems described herein may be realized as a software component or
components operating on a conventional data processing system such
as a Unix workstation. In that embodiment, the DCIP system may be
implemented as a C language computer program, or a computer program
written in any high level language including C++, Fortran, Java or
basic. Additionally, in an embodiment where microcontrollers or
DSPs are employed, the DCIP systems may be realized as a computer
program written in microcode or written in a high level language
and compiled down to microcode that can be executed on the platform
employed. The development of such systems follows from techniques
known to those of skill in the art, and such techniques are set
forth in Digital Signal Processing Applications with the TMS320
Family, Volumes I, II, and III, Texas Instruments (1990).
Additionally, general techniques for high level programming are
known, and set forth in, for example, Stephen G. Kochan,
Programming in C, Hayden Publishing (1983). It is noted that DSPs
are particularly suited for implementing mathematical functions,
including encryption functions. Developing code for DSP and
microcontroller systems follows from principles well known in the
art.
[0131] Additionally, although FIG. 1 graphically depicts the DCIP
systems 10 as an arrangement of interconnected functional block
elements, it will be apparent to one of ordinary skill in the art
that these elements can be realized as computer programs or
portions of computer programs that are capable of running on a data
processor platform to thereby configure the data processor as a
system according to the invention. Moreover, although FIG. 1
depicts the system 10 as an integrated unit, it will be apparent to
those of ordinary skill in the art that this is only one
embodiment, and that the invention can be embodied as a group of
computer programs that operate on different separate machines,
including machines located at different physical locations, such as
machines located at a clinical site and machines located at the
site of a trusted intermediary, with the different sites
communicating for example across a data network such as the
Internet.
[0132] Accordingly, the systems and methods described above are
merely representative of the different embodiments that may be
realized from the invention, and other systems and applications may
be realized, including for example systems for allowing attorneys
to identify member of a particular class that may have a common
cause of action, systems for organizing clinical trials,
post-marketing surveillance, and patient recruitment for genetic
and genomic research, as well as the delivery of molecular
diagnostics and therapeutics.
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