| IUPUI
HRPP Receives Qualified Accreditation Requiring Revisions to IRB Policies,
Procedures, and Forms
What Does
That Mean to Me?
As part of our
self-assessment process, it was necessary to revise some of our policies
and procedures in order to improve and raise the bar for our HRPP.
These revisions affected many documents, including the IUPUI/Clarian
Standard Operating Procedures (SOPs), IRB application forms, and the
IRB instruction packet. As part of our pledge to AAHRPP, we agreed
to implement these revisions by the end of the summer. As such, we
would like to outline those revisions and explain the implementation
process. Revised forms and SOPs are now posted on the Research Compliance
Administration (RCA) Web site at:
http://www.iupui.edu/~respoly/human-sop/human-sop-index.htm.
Change
in Unanticipated Problems Involving Risks to Subjects or Others and
Noncompliance Policies and Procedures
In order to ensure
consistency in policies and procedures related to unanticipated problems,
adverse events, protocol deviations, noncompliance, and the associated
reporting requirements, the following three SOPs were eliminated:
(1) Handling Serious and/or Continuing Noncompliance with Human Subjects
Regulations; (2) Handling Unanticipated Problems Involving Risks to
Subjects and Protocol Deviations and Violations; and (3) Reporting
Adverse Events to the IRB and the following two SOPs have been developed:
Unanticipated Problems Involving Risks to Subjects or
Others and Noncompliance (v 06/05) and Reporting
(v 02/15/05). You will notice that we no longer have
separate adverse event and protocol deviation reporting policies;
rather, those events are now considered subsets of the unanticipated
problems involving risks to subjects or others policy. These two new
SOPs are now open for public comment and can be viewed at: http://www.iupui.edu/~respoly/human-sop/human-sop-index.htm.
Following the public comment period and after appropriate revisions
have been made, they will be considered approved and become effective
immediately, at which time the three previously approved SOPs will
be removed from the Web site and no longer effective.
NOTE REGARDING
THE ONLINE ADVERSE EVENT REPORTING SYSTEM: Because of the
changes in the unanticipated problems and noncompliance SOP, the online
adverse event system will become obsolete. Following the public comment
period and after appropriate revisions have been made to these two
SOPs, they will be considered approved and become effective immediately
at which time the online adverse event reporting system will be taken
down and no longer used. However, adverse events already submitted
through that system will be processed as usual.
Change
in Application Processes
Another big change
is the addition of two (2) application processes. Prior to going through
our self-assessment, the institution defined and included in its human
subjects research submission process all student projects and research
NOT with human subjects, but subject to HIPAA regulations. Because
these activities do not actually represent research with human subjects,
they do not technically fall under the IRB’s authority. However,
the institution has given authority to the IRB to review these non-human
subjects research activities. Thus, the different activities have
been clearly defined and separate application processes were developed
for each. For example, although some student projects don’t
meet the definition of human subjects research, the IRB must still
review such a project if it involves a vulnerable population (e.g.
children, prisoners, cognitively impaired) and may place them at increased
risk. These projects are submitted to the IRB using the Non-Research
Student Projects Application Form (v 02/05). Likewise, for
research using data derived from a limited data set, involving only
de-identified data created from PHI from a HIPAA covered entity, involving
one or more deceased individuals only, or research involving coded
private information of biological specimens, the Research
Not Subject to the FDA or Common Rule Definitions of Human Subjects
Research (v 05/05) is to be completed and submitted to the
IRB (certain exceptions may apply). Activities that do represent human
subjects research will continue to be submitted on the usual (although
revised) human subjects application forms. To aid in understanding
which submission process to follow, a checklist has been developed
to guide you to the appropriate submission paperwork (Checklist
for Determining Whether an Activity Requires Review by the IUPUI/Clarian
IRB (v 06/05)).
Changes
to Existing Standard Operating Procedures (SOPs)
Many of the other
SOPs have also been revised and those revisions are delineated below.
Please refer to: http://www.iupui.edu/~respoly/human-sop/human-sop-index.htm
to view the SOPs.
- Auditing
of Research Involving Human Subjects (v 02/15/05) –
clarified that the HSR Auditor may identify unanticipated problems
involving risks to subjects or others (¶ 2 of Introduction),
that if audit findings indicate unanticipated problems involving
risks to subjects or others or noncompliance, they should be reported
to the IRB accordingly (5.4.1, 5.4.2), and that the HSR Auditor
may be sent on special assignment to investigate allegations or
reports of unanticipated problems involving risks to subjects or
others or noncompliance (5.4.4).
- Children
in Research (v 05/05) – clarified the definitions
of children (4.3), LAR (4.9), and persons authorized to consent
for incapable parties (children) (4.14), when an assent document
is required (5.2.1), and procedures for obtaining assent (5.2.4).
- Collection,
Storage and/or Use of Biological Specimens for Research (v 05/05)
– included the definition of Clarian Health Partners (Clarian)
(4.4) and expanded the definitions of a human subject (4.13), privacy
(4.19), and research (4.24).
- Conflict
of Interest Reporting to the IRB (v 04/05) – numerous
revisions made to bring together the IUPUI, IU and Clarian COI policies
(4.4, 4.5, 4.6, 4.7, 5.4).
- Data
Management (v 05/05) – clarified that the SOP does
not address the data management of the IRB (3.), that the VA claims
ownership of its patients’ data (5.1.1), and the state and
federal laws regarding public access to research data (5.9.4).
- Emergency
Use of and Planned Emergency Research with Investigational Agents
or Devices (v 02/15/05) – clarified that the investigator
should notify the IRB of intent to employ a one-time emergency use
(5.1.2), procedures for one-time emergency use (5.2.2, 5.2.2.1,
5.3.6), when a person given a test article on an emergency basis
is considered a research subject (5.3.2, 5.5.5), and that the IRB
will ensure all regulations are followed when a one-time time emergency
use is employed (5.5.4).
- Exempt
and Expedited New Study Approval Process (v 05/05) –
clarified the definition of children (4.1), the use of audio and
video taping for exempt studies (¶ following 5.1.3.2), types
of research that cannot be considered exempt (5.2.3, 5.2.4), the
requirements for acceptance of exempt studies (5.3.4, 5.3.5), the
use of consultants in the review of exempt and expedited research
(5.3.6, 5.5.1), and the authority of expedited IRB reviewers (5.5.1),
and included the checklist for determining whether an activity requires
review by the IUPUI/Clarian IRB.
- Human
Subject Identification, Selection, and Recruitment (v 02/15/05)
– revised the definition of recruitment (4.6) and clarified
what basic trial information is (5.5.2).
- Investigational
Device Accountability (v 06/05) – clarified additional
requirements for investigators using investigational devices (5.1),
slightly revised Appendix A.
- Investigational
Drug Accountability (v 06/05) – clarified additional
requirements for investigators not using Investigational Drug Services
for the use of investigational drugs (5.1.3), reporting requirements
for dosing changes (5.6.3.3), and the importance of maintaining
reports of unanticipated problems involving risks to subjects or
others and noncompliance (Appendix D).
- IRB
Operations and Study Approval Process (v 05/05) –
revised the definitions of suspension (4.16) and termination (4.17),
clarified the IRB’s authority (5.1.2), explained the coordination
of VA appointments to the IRB (5.1.6.3), and clarified requirements
for regularly reviewed research with vulnerable populations (5.1.8)
and VA research (5.1.9), allowable expedited review for studies
involving prisoners (5.1.10.2), requirements of new IRB members
(5.1.10.4), IRB member expectations prior to an IRB meeting (5.2.3),
voting requirements of alternate IRB members and consultants (5.3.1),
IRB member designation process (5.5), other committees used in conjunction
with the Methodist IRB (5.7, Appendix C), privacy (5.8.2.6.1) and
confidentiality (5.8.2.6.2), expedited and exempt review process
(5.8.8-5.8.11), special considerations for cognitively impaired
subjects (5.9.1.4), what other projects the IRB reviews besides
human subjects research (5.10.1), the IRB reviewer system (5.10.5),
the basis for determining continuing review intervals (5.10.8),
what is included in research activities that must cease when a research
study expires (5.10.10), and the possibility of providing information
about protocol changes to subjects (5.10.12), included a listing
of materials provided for reviewers for the various action items
(Appendix B) and the checklist for determining whether an activity
requires review by the IUPUI/Clarian IRB (Appendix D).
- Obtaining
and Documenting Informed Consent (v 06/05)
– clarified the definitions of assent (4.1), children (4.2),
clinical investigation (4.3), cognitively impaired (4.4), individuals
with delegated authority to consent on behalf of an incapable party
(4.6), legally authorized representative (4.12), and persons authorized
to consent for an incapable party (4.14), included additional examples
of source documents (4.16.), clarified requirements for person conducting
the consent process (5.7.2.1), VA-specific requirements regarding
informed consent (5.7.2.2, 5.11, last ¶ under 5.17.3, 5.19),
considerations and requirements regarding informed consent and cognitively
impaired subjects (5.17.3), and documentation, waiver, and waiver
of documentation requirements of informed consent (5.19, 5.19.1,
5.20.4, 5.20.5).
- Policies
and Procedures for the IUPUI/Clarian Standard Operating Procedures
(v 11/10/04) – revised process for the revision of
SOPs (Appendix A).
- Pregnant
Women, Human Fetuses, Neonates, and Fetal Material in Research (v
02/15/05)
– changed “tissue transplantation” to “material”
throughout the document.
- Prisoners
in Research (v 02/15/05)
– clarified requirements for request to access offender or
juvenile records for research purposes (5.3.2).
- Responsibilities
of Principal Investigators (v 04/05)
– clarified completion of sponsor-required documents (5.1.15),
requirements for investigators conducting research at the VA (5.1.17),
requirement to promptly report study completion (5.2.2) and unanticipated
problems involving risks to subjects or others and noncompliance
(5.2.4) to the IRB, and requirements for an investigator assuming
the role of sponsor in an IND- or IDE- study (5.4.3).
- Safety/Risk
Assessment and Oversight Plan for Research (v 04/05) –
revised the definition of the HSR Auditor (4.4), the flowchart for
when an IND is required (Appendix A), and the flowchart for significant
and non-significant risk medical device studies (Appendix B).
- Student
Projects (v 04/05) – entire SOP revised to clarify
the different types of student projects and their appropriate submission
requirements (see specifically section 5.7). The following definitions
were added: covered entity (4.1), limited data set (4.4), private
information (4.5), protected health information (4.6).
Changes
to Human Subjects Submission Forms
Because of the
changes necessary to the SOPs, it necessitated revisions to many of
the existing human subjects submission forms, including the exempt
and expedited research checklists, informed consent checklist and
template, the IRB instruction packet, and the summary safeguard statement.
Changes to these forms are delineated below. Please refer to http://www.iupui.edu/%7Eresgrad/spon/download2.htm
to view the revised forms.
- Exempt
Research Checklist (v 05/05) – clarified that research
activities can only be considered exempt if they are considered
minimal risk and the only involvement of human subjects falls within
one or more of the federally-specified exempt activities, that research
activities cannot be considered exempt if they involve prisoners
or a test article regulated by the FDA (certain exceptions apply),
included additional questions regarding the use of audio or video
recording and providing data points for research involving the collection
of existing data, specimens, etc., removed all of the HIPAA-specific
information since that information is now included in a separate
application process, included performance sites and additional questions
related to recruitment and protection of privacy, confidentiality,
and potential risks.
- Expedited
Research Checklist (v 02/05)
– removed all of the HIPAA-specific information since that
information is now included in a separate application process.
- Informed
Consent Statement Checklist (v 06/05)
– removed requirement for use of the Y-1 form for consenting
hospital or clinic patients, noted specific agencies that may inspect
subjects’ medical or research records (item 7.), revised the
cost, payment and injury statements and removed the VA-specific
verbiage since a VA-specific consent is now required to enroll VA
subjects (item 8.), clarified RCA as alternate contact when PI cannot
be reached and for problems, concerns, question, etc. (items 9.
and 10.), clarified when additional elements of information should
be included in the informed consent (items 14.-18.) and that stored
de-identified specimens need not state a specific type of future
research (item 20.).
- Informed
Consent Statement Template
– additional verbiage added to address the changes made in
the informed consent statement checklist.
- IRB
Instruction Packet (v 02/05)
– added information regarding new application processes (section
V) and studies to be conducted within Wishard Health Services (section
VI), revised the guidelines for eligibility for research protocol
submissions (appendix A), included the checklist for determining
whether an activity requires review by the IUPUI/Clarian IRB (appendix
C) and a list of the SOPs (section I), and removed all of the forms
from within the packet, although they are still accessible on the
RCA forms website at: http://www.iupui.edu/%7Eresgrad/spon/download2.htm.
- Reporting
Form for Reporting Events that Require Prompt Reporting to the IRB
(v 06/05) – this is a new reporting form that was
developed as part of the revised unanticipated problems policy and
procedures. Once the associated SOP has become effective, this form
will also become effective.
- Summary
Safeguard Statement (v 05/05) – major changes are
delineated below:
-
Section III: Subject Population
– additional questions must now be answered when you are
targeting any of the following subject populations: 1) children;
2) cognitively impaired; 3) pregnant women, human fetuses, or
fetal material; 4) prisoners; or 5) students.
- Section
VII: Protection Procedures – You are now required
to explain how you will protect the privacy interests of subjects
and how communication and information will be managed with other
sites when IUPUI/Clarian is the lead site in a multi-site study.
-
Section VIII: Data Safety Monitoring Plan
– For all full review studies, you are now required to
develop a data safety monitoring plan or identify where in the
protocol one exists. (Note: This is not necessarily the same
as a data safety monitoring board [DSMB]).
- Section
XIII: Informed Consent – Additional questions
have been added to solicit information about the informed consent
process for a given study, to support a modification to the
informed consent document, and to request an exception from
the informed consent requirements for studies involving planned
emergency use.
- Section
XX: Investigational Drugs/Devices – Additional
questions and requirements are now included in this section
to verify the IND or IDE number and to ensure understanding
of responsibilities when the investigator, IU or Clarian holds
the IND or IDE and when the investigator is not using the Investigational
Drug Pharmacy when an IND is involved or when an IDE is involved.
Implementation
Timelines
For Existing
Studies: You will be required to implement the new changes
and update paperwork (e.g. summary safeguard statement, informed consent)
at the time of your study’s continuing review beginning with
the continuing reviews due in September. A checklist of necessary
changes for existing studies will be supplied at the time your continuing
review is e-mailed. Using that checklist, you should make the appropriate
changes to the required study documents and submit them to the IRB
with your continuing review. It is not necessary to submit these accreditation-required
changes via an amendment. If the necessary changes are not made when
submitting your continuing review to the IRB, this may cause delay
to the approval of your continuing review.
For New
Studies/Projects: Polices, procedures and forms should be
used immediately (except those related to the unanticipated problems
and noncompliance policies and forms). However, if you have already
started to complete a human subjects application on the “old”
forms, you may continue to submit those forms through the August,
2005 IRB meetings. However, beginning with the September IRB meetings,
you are required to submit the new application forms posted on the
RCA Web site at: http://www.iupui.edu/%7Eresgrad/spon/download2.htm.
Please send any questions,
comments, or concerns to resrisk@iupui.edu.
|
