Major Revisions:
v 06/05 to v 10/05
1. Added URL for submission
forms (p.2, 1st paragraph under “Instructions and Forms for
completing IRB Submissions”)
2. Added 2006 IRB meeting deadline dates (p.6)
3. Removed the requirement of a
mentor letter for new investigators in the Department of Medicine for exempt
research (p.7, submission requirements under “Exempt from Full Review”)
4. Clarification that final IRB
approval cannot be granted until appropriate documentation from the radiation
safety committee is received, if applicable (p.12, under “Radiation and/or
Radioactivity”)
5. Clarification that approval
from Midtown Mental Health Clinic is required before final IRB approval can be
granted (p.12, under “Midtown Mental Health Clinic”)
6. Clarification that, if
appropriate, SRC approval must be included with your IRB submission material
(p.13, under “Scientific Review Committee”)
7. Clarification that all new
PIs in the Department of Medicine who are submitting to the IRB for the first
time must identify a mentor and submit a letter from that individual
demonstrating their support (Appendix A, p.2)
IUPUI AND CLARIAN
INSTITUTIONAL REVIEW BOARDS
Revised 10/05
Table of Contents
Section I: Introduction….............................................................................................. 1
Specific
IUPUI/Clarian SOPs................................................................................... 1
Section II: Protocol Review Process........................................................................ 1
Instructions
and Forms for Completing IRB Submissions............................................ 2
Deadlines................................................................................................................ 2
IRB
Reviews.......................................................................................................... 2
Submission
of the Same Research Protocol by a Different Investigator........................ 2
Just-In-Time
Review for NIH Proposals Involving Human Subjects Research…........... 3
Human
Subjects Protection Test Requirement........................................................... 3
Withdrawal
of Human Subjects Research Application from the Review Process........... 3
Section III:.. Collaborations, Multicenter
Studies, Offsite Research and Non-Affiliated
Investigators................................................................................................ 3
When is a Federalwide Assurance (FWA) needed?..................................................... 3
Relying on Another Institution’s IRB Approval.......................................................... 4
Performance
sites that are considered “engaged” in research but need a letter of
cooperation instead of an FWA................................................................................. 4
Examples of
being “engaged” in research for multicenter studies where the IUPUI/Clarian
site is not directly conducting the trial.................................................. 4
When IUPUI
faculty are collaborating with Purdue University.................................... 4
When Purdue
pharmacy faculty wish to conduct research at an IUPUI facility............. 5
When both IUB
and IUPUI campuses and/or faculty are involved in research.............. 5
Performance
sites that are not considered “engaged” in research but need a letter of cooperation............................................................................................................. 5
When IU is just
one site in a multicenter study, but not the lead site............................. 5
Cooperating
Departments with the IUPUI/Clarian Systems......................................... 5
Non-Affiliated
Investigators...................................................................................... 5
Section IV:................................................. IRB
Deadlines and Description of IRBs 6
Section V: Submission Requirements......................................................................... 7
Non-Research
Student Projects................................................................................ 7
Research
not Subject to FDA or Common Rule Definitions of Human Subjects Research 7
Exempt
from Full Review........................................................................................ 7
Expedited
Review.................................................................................................... 8
Full
Board Review................................................................................................... 8
§
IRB-01 –
Behavioral/Social Sciences................................................................... 8
§
IRB-02, IRB-04, IRB-05
– IUPUI Biomedical..................................................... 9
§
IRB-03 – Methodist
Biomedical.......................................................................... 9
§
IRB Submission
Documents............................................................................. 10
§
IRB Actions.................................................................................................... 11
Section VI:............................................................................ Additional
Information 12
Other
Reviews...................................................................................................... 12
§
Infectious
Agents, Hazardous Materials or Other Chemicals................................ 12
§
Radiation and/or
Radioactivity.......................................................................... 12
§
General Clinical
Research Center (GCRC)......................................................... 12
§
Midtown Mental
Health Clinic.......................................................................... 12
§
Veterans Affairs
(VA)...................................................................................... 12
§
Wishard Hospital
and Clinics............................................................................ 12
§
Scientific Review
Committee............................................................................ 13
APPENDIX A: Principal
Investigator and Faculty Sponsor Eligibility at IUPUI/Clarian
APPENDIX B: Indiana
University Protocol Review Procedures for Human Subjects
APPENDIX C: Checklist
for Determining Whether an Activity Requires Review by the IUPUI/Clarian IRB
Section
I: Introduction
The purpose of this packet is
to give access to and guidance on how to complete the forms for submission to
the IUPUI/Clarian IRBs. All policies and
procedures are contained within the IUPUI/Clarian Standard Operating Procedures
(SOPs) located at: http://www.iupui.edu/~respoly/human-sop/human-sop-index.htm. IRB policies are no longer provided within
this document.
Specific IUPUI/Clarian Standard Operating
Procedures (SOPs) include:
1.
Auditing of Research Involving Human Subjects
2.
Children in Research
3.
Collection, Storage, and/or Use of Biological Specimens for
Research
4.
Conflict of Interest
5.
Data Management
6.
Emergency Use of and Planned Emergency Research with
Investigational Agents or Devices
7.
Exempt and Expedited New Study Approval Process
8.
Handling Humanitarian Use Devices
9.
Human Subject Identification, Selection, and Recruitment
10.
Investigational Device Accountability
11.
Investigational Drug Accountability
12.
IRB Operations and Study Approval Process
13.
Obtaining and Documenting Informed Consent
14.
Policies and Procedures for the IUPUI/Clarian SOPs
15.
Pregnant Women, Human Fetuses, Neonates, and Fetal Tissue
Transplantation in Research
16.
Prisoners in Research
17.
Reporting
18.
Research Personnel Qualifications and Training
Documentation
19.
Responsibilities of Principal Investigators
20.
Safety/Risk Assessment and Oversight Plan for Research
Involving Human Subjects
21.
Security of Research Data
22.
Student Projects
23.
Subject Confidentiality and Privacy
24.
Unanticipated Problems Involving Risks to Subjects or
Others and Noncompliance
The administrative support
services for the IUPUI/Clarian IRBs are provided by Research Compliance
Administration (RCA) and the Methodist IRB Office. If an investigator is uncertain about whether
research requires IRB review, the appropriate office should be contacted for
guidance.
Instructions and Forms for Completing IRB
Submissions
The person responsible for
overseeing a research project (principal investigator or PI) involving human
subjects must ensure appropriate IRB review and approval is obtained before
undertaking any project activities. In
the case of student projects, this individual is the faculty sponsor. Please refer to Appendix C to determine if
your project requires IRB review. The
submission and all related documents, e.g., amendments, continuing reviews,
etc., must be personally signed by the PI (or faculty sponsor), unless specific
exceptions apply. Instructions for completing
the required forms can be obtained in this instruction packet or from RCA or
the Methodist IRB office. Submission
forms can be obtained at: http://www.iupui.edu/%7Eresgrad/spon/download2.htm. Applications and any related documents are to
be forwarded to the appropriate office where they will be processed and
directed to the appropriate committee for review.
To facilitate approval of your
submission, it is necessary for all relevant information to be completed as
outlined in this instruction packet. If
required, the protocol must include a clear and concise explanation of the
proposed research. Particular attention should be paid to the informed consent
statement and authorization form, if they are required. The informed consent statement must be
written in simple, clear language (8th grade level), which is intelligible to
the average layman with no prior scientific knowledge, i.e., all technical and
medical terminology should be defined.
The Authorization for the Release of Health Information template must be
used when an authorization is required for a study. In addition, particular attention should be
paid to recruitment, as well as the measures used to safeguard health
information.
Deadlines
There are no deadline
requires requirements for submission to the IRB, EXCEPT for full review
research protocols. The deadlines for
submitting full review research protocols are indicated under Section IV of this instruction packet. These deadlines are strictly adhered to. Early submissions will increase opportunity
for discussion and resolution of issues in advance of the deadline. Incomplete or hand-written submissions will
not be accepted for review, and proposals submitted after the deadline will not
be reviewed until the following month.
Therefore, investigators may minimize the time it takes to receive final
approval by carefully preparing the submission so that it meets the guidelines
of the IRB on its first submission.
IRB Reviews
All activities requiring
review by the IRB (refer to Appendix C for information on what activities
require IRB review) must receive final written approval (or acceptance) from
the IUPUI/Clarian Institutional Review Board (IRB) or appropriate delegate prior
to initiation of the activity. For human
subjects research, applications should be submitted to the IRB that is best
able to assess the role of the subject in the proposed research and to
determine whether provisions have been made for protection of the subject's
rights and welfare. A listing of the
specific expertise on each IRB committee can be found under Section IV of this
instruction packet.
Generally, research that
involves risks principally of a medical or physical nature are to be submitted
to the biomedical (IRB-02, -03, -04, or –05) IRBs. Research involving risks that are principally
behavioral, psychological or social in nature are to be submitted to the
behavioral/social sciences (IRB-01) IRB.
Any subsequent materials submitted for review (e.g. amendments,
continuing reviews, etc.) will be reviewed by the IRB that initially reviewed
the research unless there is justification to do otherwise.
Submission of the Same Research by a
Different Investigator
The IRB will not routinely
accept for review research involving human subjects that is essentially the
same study submitted by different investigators. Investigators are urged to collaborate with
one another and submit one research application for IRB review. Questions or requests for exceptions
regarding this policy should be directed to the RCA or Methodist IRB
office. If for some reason the
investigators cannot collaborate and submit one research application for IRB
review, at the time each application is submitted for IRB review, a memo should
be included explaining why this collaboration cannot occur.
Just-In Time Review for NIH Proposals
Involving Human Subjects Research
The NIH Just-in-Time
procedures make it no longer necessary to obtain IRB approval within 60 days of
proposal submission. Investigators are
now required to obtain IRB approval when there is evidence that funding will be
received. Investigators should not
submit research applications to the IRB until there is evidence that the
proposal is in a fundable range. This
procedure should not be problematic since the priority score is assigned early
and allows adequate time to run the study through the IRB process. Additionally, this procedure allows the
investigator to make changes, as requested by the study section, before the
study is submitted to the IRB.
Human Subjects Protection Test
Requirement
It is a requirement that all
principal investigators and co-investigators listed on the summary safeguard
statement of an IUPUI/Clarian human subjects research application pass the
human subjects protection test before research can be initiated. The course and test can be found at: http://www.iupui.edu/%7Eresgrad/Human%20Subjects/human-menu.htm.
The
IRB recognizes that research applications in the process of review may be
withdrawn by the sponsor and/or the investigator. Any changes in the status of the research
need to be submitted in writing to RCA or the Methodist IRB Office.
While
most human subjects research studies at IUPUI/Clarian will take place in
IUPUI/Clarian facilities by IUPUI/Clarian investigators only, there are many
variables which may allow for collaborations with multiple sites or multiple
investigators. In those instances, other
requirements may apply. See below for
frequent scenarios affecting human subjects researchers on this campus.
When
is a Federalwide Assurance (FWA) needed?
An institution
becomes "engaged" in human subjects research when its employees or
agents1 (i) intervene or interact with living individuals for
research purposes; or (ii) obtain individually identifiable private
information for research purposes [45
CFR 46.102(d),(f)].
An institution is
automatically considered to be "engaged" in human subjects research
whenever it receives a direct HHS award to support such research. In such
cases, the awardee institution bears ultimate responsibility for protecting
human subjects under the award.
When IUPUI/Clarian
investigators are conducting research, the institution where the research will
be done is “engaged” meeting one of the two definitions above and federal
funding is involved, the institution that is “engaged” must have a Federalwide
Assurance (FWA) approved by the Office of Human Research Protections
(OHRP). This most often happens in
clinics or hospitals that are not affiliated with IUPUI/Clarian. The FWA requires that institutions engaged in
research comply with the federal human subjects research regulations. Those institutions holding an FWA designating
an IUPUI/Clarian IRB as their IRB of record are listed at: http://www.iupui.edu/%7Eresgrad/spon/fwa.htm. If the institution in which you are
conducting research is not on this list, please contact the RCA Office for
details on how to proceed and how to obtain an FWA.
1 Agents include all individuals performing
institutionally designated activities or exercising institutionally delegated
authority or responsibility.
Relying
on Another Institution’s IRB Approval:
An
IUPUI/Clarian IRB must be the IRB of record for any research being conducted on
behalf of IUPUI/Clarian, using IUPUI/Clarian facilities (see below exceptions)
or enrolling IUPUI students; however, there have been rare instances where the
IUPUI/Clarian IRBs have relied on the review of another institution’s IRB. There have also been cases where another
institution has relied on the IUPUI/Clarian IRB review. In each case, each IRB must have a Federalwide
Assurance (FWA). The IRBs must also
enter into an IRB authorization agreement.
See a sample IRB authorization agreement: http://www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf
and contact the RCA Office before proceeding.
Performance
sites that are considered “engaged” but need a letter of cooperation instead of
an FWA:
When
IUPUI/Clarian investigators are conducting research, the institution where the
research will be conducted is “engaged” meeting one of the two definitions
above and federal funding is not involved, the institution that is
engaged must submit a letter of cooperation to the IUPUI/Clarian IRB of record
reviewing the study. FWAs only need to
be obtained when federal funding is involved.
The
investigator should also be aware of any requirements of the institution where
the research will be conducted for separate IRB approval from that institution,
if necessary. If IRB approval is
required at the institution where the research is conducted, a copy of the IRB
approval from that institution should be submitted to the IUPUI/Clarian IRB in
lieu of a letter of cooperation.
Examples of
being “engaged” in research for multicenter studies where the IUPUI/Clarian
site is not directly conducting the trial:
An institution is
considered “engaged” when its employees or agents obtain, receive, or possess
private information that is individually identifiable (either directly or
indirectly through coding systems) for the purpose of maintaining
"statistical centers" for multi-site collaborative research. Where
institutional activities involve no interaction or intervention with subjects,
and the principal risk associated with institutional activities is limited to
the potential harm resulting from breach of confidentiality, the Institutional
Review Board (IRB) need not review each collaborative protocol. However, the
IRB should determine and document that the statistical center has sufficient
mechanisms in place to ensure that (i) the privacy of subjects and the
confidentiality of data are adequately maintained, given the sensitivity of the
data involved; (ii) each collaborating institution holds an applicable approved
Assurance; (iii) each protocol is reviewed and approved by the IRB at the
collaborating institution prior to the enrollment of subjects; and
(iv) informed consent is obtained from each subject in compliance with HHS
regulations.
An
institution is considered engaged when its employees or agents maintain
"operations centers" or "coordinating centers" for
multi-site collaborative research. Where institutional activities involve no
interaction or intervention with subjects, the IRB need not review each
collaborative protocol. However, the IRB should determine and document that the
operations or coordinating center has sufficient mechanisms in place to ensure
that (i) management, data analysis, and Data Safety and Monitoring (DSM)
systems are adequate, given the nature of the research involved; (ii) sample
protocols and informed consent documents are developed and distributed to each
collaborating institution; (iii) each collaborating institution holds an
applicable OPRR-approved Assurance; (iv) each protocol is reviewed and approved
by the IRB at the collaborating institution prior to the enrollment of
subjects; (v) any substantive modification by the collaborating institution of
sample consent information related to risks or alternative procedures is
appropriately justified; and (vi) informed consent is obtained from each
subject in compliance with HHS regulations.
The
local PI is responsible for forwarding the above information to the IRB for
review and approval.
When
IUPUI faculty are collaborating with Purdue University:
IUPUI
and Purdue University have entered into a cooperative agreement which allows
for only one IRB review to take place, i.e., both sites do not have to review
and approve the study when human subjects research is being conducted at both
sites or involves investigators from both sites. Please contact the RCA Office for more
details.
When
Purdue pharmacy faculty wish to conduct research at an IUPUI facility:
IUPUI
and Purdue have entered into an agreement which allows for review by one of the
IUPUI IRBs when Purdue Pharmacy faculty will conduct human subjects research at
an IUPUI facility. Please contact the
RCA Office if you are a Purdue Pharmacy faculty member wishing to conduct
research at IUPUI for more details.
When
both IU Bloomington (IUB) and IUPUI campuses and/or faculty are involved in
research:
IUB
and IUPUI have entered into an agreement which allows for review by only one
campus when the investigator resides on campus (IUPUI or IUB) and the research
will be conducted on the other campus.
If you are an investigator on one of these IU campuses and wish to
conduct human subjects research on the other campus, please contact the RCA Office
for details on where and how to apply.
Performance
sites that are not considered “engaged” but need a letter of cooperation:
Institutions
(e.g., schools, nursing homes, businesses) that permit use of their facilities
for intervention or interaction with human subjects by research investigators
(e.g., a school permits investigators to test students whose parents have
provided written permission for their participation; a business permits
investigators to solicit research volunteers at the worksite) are not
considered “engaged” and therefore do not need to obtain a federalwide
assurance if federal funding is involved.
However, the IRB will still require a letter of cooperation from the
site allowing it to be used in research by the IUPUI/Clarian investigator.
When IU is just one site in a multicenter study, but
not the lead site:
Regardless of the
funding source, a multicenter human subjects protocol in the format agreed upon
by the multicenter group may be accepted for review by the IUPUI/Clarian IRB.
However, the informed consent statement must conform to the format
required by the IUPUI/Clarian IRB.
Cooperating Departments within the IUPUI/Clarian
Systems:
If it is anticipated that
another department within the IUPUI/Clarian system or its affiliated
institutions may be involved in human subjects research, a co-investigator from
each cooperating department must be listed under Section XXI of the summary
safeguard statement.
Non-Affiliated Investigators
When a researcher is aware of
or reasonably anticipates that a study subject may have any aspect of protocol-specific
procedures provided or performed by an individual not employed or otherwise
affiliated with IUPUI/Clarian (e.g. the subject’s local physician who is not affiliated
with IUPUI/Clarian and does not have local IRB approval for the protocol at his/her
facility), steps should be included to address that scenario within the body of
the protocol and in the summary safeguard statement before submission of the
protocol to the IRB. When the
participation of a non-affiliated practitioner is not anticipated prior to
submission of the protocol to the IRB, the research will require IRB approval
by means of an amendment to the study which will, most often, require full IRB
review before the non-affiliated practitioner may participate in
protocol-specific procedures. The
amendment must specifically describe what procedures will be performed by the
non-affiliated investigator. A specific,
written agreement must be established in advance with any non-affiliated
investigator. See Guidelines
Concerning Participation by Non-Affiliated Investigators in Research Protocols
for additional information and for the agreement.
IUPUI and Clarian Institutional Review Boards
The Institutional Review Boards (IRBs) at IUPUI
and Clarian Health Partners are responsible for the review and approval of all
research involving human subjects conducted under the auspices of these (and
affiliated) institutions. There are five
IRBs, each of which are qualified and established to review the type of
research submitted to it. Please note
the expertise of each IRB and submit your research application
accordingly. If you have questions about
which IRB to submit your study, please contact the RCA office. Pay particular attention to the deadlines to
ensure that the submission meets the deadline requirements for the specific IRB
that will be reviewing the study. Also,
please note that subsequent documentation (e.g. amendments, continuing reviews,
etc.) must be submitted to the IRB that originally reviewed the study. DEADLINES: Documents must be received in the
RCA (for studies submitted to IRB-01, IRB-02, IRB-04, and IRB-05) or the
Methodist IRB office (for studies submitted to IRB-03) by 12:00 noon on the
deadline day. IRB meetings generally
fall (2) weeks after the deadline.
IRB-01
– Behavioral/Social Sciences – Behavioral/social sciences research for IUPUI
and Clarian investigators.
Monday, September 26, 2005 Monday, February 20, 2006 Monday, July 24,
2006
Monday, October 24, 2005 Monday, March 27, 2006 Monday,
August 21, 2006
Friday, November 18, 2005 Monday, April 24, 2006 Monday,
September 25, 2006
Monday, December 19, 2005 Monday, May 22, 2006 Monday,
October 23, 2006
Monday, January 23, 2006 Monday, June 26, 2006 Monday,
November 20, 2006
IRB-02 – IUPUI Biomedical – Hematology/oncology,
pediatrics, nephrology, infectious diseases, dentistry, neurology,
endocrinology, genetics, and general medicine.
Monday, October 17, 2005 Monday, March 27, 2006 Friday,
August 25, 2006
Thursday, November 17, 2005 Monday, April 24, 2006 Monday,
September 25, 2006
Monday, December 19, 2005 Friday, May 26, 2006 Monday,
October 23, 2006
Monday, January 23, 2006 Friday, June 23, 2006 Thursday,
November 16, 2006
Monday, February 20, 2006 Monday, July 24, 2006
IRB-03 – Clarian and
Methodist Hospital – Primarily reviews biomedical research
conducted at the Methodist Hospital campus or collaborative research between
Clarian investigators.
Tuesday, October 4, 2005 Tuesday, March 7, 2006 Tuesday,
August 1, 2006
Tuesday, November 1, 2005 Tuesday, April 4, 2006 Tuesday,
September 5, 2006
Tuesday, December 6, 2005 Tuesday, May 2, 2006 Tuesday,
October 3, 2006
Tuesday, January 3, 2006 Tuesday, June 6, 2006 Tuesday,
November 7, 2006
Tuesday, February 7, 2006 Wednesday, July 5, 2006 Tuesday,
December 5, 2006
IRB-04 – IUPUI
Biomedical – Pediatrics, oncology, radiation oncology, dentistry, cardiology,
surgery, psychiatry, neurology, OB/GYN, and general medicine.
Monday, September 26, 2005 Monday, February 27, 2006 Monday, July 31,
2006
Monday, October 24, 2005 Monday, April 3, 2006 Friday,
September 1, 2006
Monday, November 28, 2005 Monday, May 1, 2006 Monday,
October 2, 2006
Friday, December 23, 2005 Monday, June 5, 2006 Monday,
October 30, 2006
Monday, January 30, 2006 Friday, June 30, 2006 Monday,
November 27, 2006
IRB-05 – IUPUI Biomedical – Infectious
diseases, pediatrics, ophthalmology, radiology, hematology/oncology, gastroenterology,
psychiatry, surgery and general medicine.
Monday, October 3, 2005 Monday, March 6, 2006 Monday,
August 7, 2006
Monday, October 31, 2005 Monday, April 10, 2006 Monday,
September 11, 2006
Monday, November 28, 2005 Monday, May 8, 2006 Monday,
October 9, 2006
Friday, January 6, 2006 Monday, June 12, 2006 Monday, November
6, 2006
Monday, February 6, 2006 Monday, July 10, 2006 Monday, December
4, 2006
Section V:
Submission Requirements
The review processes are explained in more detail as
follows:
Non-Research Student Projects:
Although the IRB was established to review and approve
research involving human subjects; the IRB has also been given the
responsibility and authority to review non-research student projects to ensure
appropriate ethical principles have been considered. To determine whether a student activity is
eligible for non-research student project review, please see Appendix C of this
instruction packet. The preliminary
determination that a student project is eligible for non-research student
project review is made by the faculty sponsor; however, the IRB makes the final
determination. Please
allow 5-10 working days for processing of this type of review. There are no deadlines for
non-research student projects.
Submission Requirements:
§
Application
Form for Non-Research Student Projects
§
Instruments
(e.g. surveys, questionnaires, etc.), if applicable
Research not Subject to FDA or Common Rule Definitions
of Human Subjects Research:
Although the IRB was established to review and approve
research involving human subjects; the IRB has also been given the
responsibility and authority to review research not subject to FDA or Common
Rule definitions of human subjects research to ensure HIPAA requirements have
been considered. To determine whether an
activity is eligible for this type of review, please see Appendix C of this
instruction packet. The preliminary
determination that an activity is research not subject to FDA or Common Rule
definitions of human subjects research is made by the investigator; however,
the IRB makes the final determination. Please allow 5-10 working days for processing of this type
of review. There are no deadlines
for non-research student projects.
Submission Requirements:
§
Application
for Research Not Subject to FDA or Common Rule Definitions of Human Subjects
Research
§
Instruments
(e.g. data collection sheets), if applicable
Exempt from Full Review:
The preliminary determination that a research project
is eligible for exempt review is made by the investigator; however, the IRB
makes the final determination. Please allow 5-10
working days for Exempt Review processing.
There are no deadlines for exempt research. However, if the IRB determines that the
research does not qualify for exempt or expedited review, it must be
resubmitted for full review in accordance with the deadline dates. Therefore, it is recommended that exempt
research be submitted a few weeks prior to the deadlines listed above in the
event that full review is required.
Early submissions will increase opportunity for discussion and
resolution of issues in advance of the investigator’s deadline.
Submission Requirements:
§
Exempt
Research Checklist
§
(1) copy of the complete grant proposal for
NIH-funded research only*. For grant
proposals that will apply to multiple research studies, a one time submission
of the proposal is deemed sufficient.
§
Research
instruments (surveys, questionnaires, interview guide, etc.), as applicable
* If the principal investigator is the recipient of
federal monies to fund his/her research, he/she must submit a copy of the
entire grant application for the IRB to review.
If the principal investigator is a sub-contractor or recipient of
federal pass-thru monies, the IRB does not need to see the entire grant
application.
Expedited Review:
The preliminary determination that a research project
is eligible for expedited review is made by the investigator; however, the IRB
makes the final determination. If an IRB
determines that a study does not meet the requirements for expedited review,
the study must then be submitted for full review by the specified deadline
date. Please allow 10-15 working days
for Expedited Review processing. It is
recommended that expedited research be submitted a few weeks prior to the
deadlines listed above in the event that full review is required. Early submissions will increase opportunity
for discussion and resolution of issues in advance of the investigator’s
deadline. There are no deadlines for
expedited research.
At
IUPUI, submit an original and (2) copies of the following:
§
Expedited Research
Checklist
§
Documentation of
Review and Approval (DRA)
§
Summary Safeguard
Statement (SSS)
§
Informed Consent
Statement (ICS) (where applicable)
§
Authorization for the
Release of Health Information for Research (where applicable)
§
Recruitment Checklist
(where applicable)
§
Protocol
§
Other
Supporting Documents (e.g. recruitment materials, research instruments)
§
(1) copy of the
mentor letter required for all new investigators in the Department of Medicine,
as applicable
§
(1) copy of the
complete grant proposal for NIH-funded research only*. For grant proposals that will apply to
multiple research studies, a one time submission of the proposal is deemed
sufficient.
At
Methodist, submit 4 sets (original + 3 copies) of the following:
§
Expedited Research
Checklist
§
Documentation of
Review and Approval (DRA)
§
Summary Safeguard
Statement (SSS)
§
Informed Consent
Statement (ICS) (where applicable)
§
Authorization for the
Release of Health Information for Research (where applicable)
§
Recruitment Checklist
(where applicable)
§
Protocol
§
Other
Supporting Documents (e.g. recruitment materials, research instruments)
§
(1) copy of the
complete grant proposal for NIH-funded research only.* For grant proposals that will apply to
multiple research studies, a one time submission of the proposal is deemed
sufficient.
* If the principal investigator is the recipient of
federal monies to fund his/her research, he/she must include a copy of the
entire grant application for the IRB to review.
If the principal investigator is a sub-contractor or recipient of
federal pass-thru monies, the IRB does not need to see the entire grant
application.
Full Board Review:
If the study does not qualify as a
non-research student project, a research project not subject to FDA or Common
Rule definition of human subjects research, or exempt or expedited review, full
review by the IRB is required. For this
type of review, submit the following materials:
§
(1) original copy
each of the DRA, SSS, ICS, Authorization, Recruitment Checklist, and recruitment
materials, where applicable
§
(14) sets of the
following (stapled):
§
Copy of the Documentation
of Review and Approval (DRA)
§
Copy of the Summary
Safeguard Statement (SSS)
§
Copy of the Informed
Consent Statement (ICS)
§
Copy of the Authorization for the
Release of Health Information for Research (where applicable)
§
Copy of Recruitment Checklist
(where applicable)
§
Copy of any recruitment
materials, where applicable
§
(3) copies of the
protocol (original plus 2 copies)
§
(3) copies of any
supporting documents (original plus 2
copies)
§
(3) copies of the
mentor letter required for all new investigators in the Department of Medicine,
as applicable
§
(1) copy of the complete grant proposal for
NIH-funded research only.* For grant
proposals that will apply to multiple research studies, a one time submission
of the proposal is deemed sufficient.
* If the principal investigator is the recipient of
federal monies to fund his/her research, he/she must include a copy of the
entire grant application for the IRB to review.
If the principal investigator is a sub-contractor or recipient of
federal pass-thru monies, the IRB does not need to see the entire grant
application.
Submit all materials to Research
Compliance Administration, 620 Union Drive, Indianapolis, IN 46202, UN 618, IUPUI. All materials must be neatly typed since they
are subject to federal inspection. For
assistance in preparing your submission, call Research Compliance
Administration at 317/274-8289. IRB-01
meetings are typically held on the 1st Friday of each month.
§
(1) original copy
each of the DRA, SSS, ICS, Authorization, Recruitment Checklist, and recruitment
materials, if applicable
§
(19) sets of the
following (stapled):
§
Copy of the Documentation
of Review and Approval (DRA)
§
Copy of the Summary
Safeguard Statement (SSS)
§
Copy of the Informed
Consent Statement (ICS)
§
Copy of Authorization for the
Release of Health Information for Research (where applicable)
§
Copy of Recruitment Checklist
(where applicable)
§
Copy of any recruitment
materials, where applicable
§
(3) copies of the
protocol (original plus 2 copies)
§
(3) copies of any
Clinical Investigator Brochures (CIBs) or package inserts for all drugs being
used in the research
§
(3) copies of any
supporting documents (original plus 2
copies)
§
(3) copies of the
mentor letter required for all new investigators in the Department of Medicine,
as applicable
§
(1) copy of the
complete grant proposal for NIH-funded research only.* For grant proposals that will apply to
multiple research studies, a one time submission of the proposal is deemed
sufficient.
* If the principal investigator is the recipient of
federal monies to fund his/her research, he/she must include a copy of the
entire grant application for the IRB to review.
If the principal investigator is a sub-contractor or recipient of
federal pass-thru monies, the IRB does not need to see the entire grant
application.
Submit all materials to Research Compliance
Administration, 620 Union Drive, Indianapolis, IN 46202, UN 618, IUPUI. All materials must be neatly typed since they
are subject to federal inspection. For
assistance in preparing materials, call Research Compliance Administration at
317/274-8289. IRB-02 meetings are
usually held on the 2nd Tuesday of each month; IRB-04 meetings are
usually held on the 3rd Tuesday of each month; and IRB-05 meetings
are usually held on the 4th Wednesday of each month, approximately
two weeks after the deadline.
(20)
sets of the following (one original and 19 copies):
§ Documentation of Review and Approval (DRA)
§
Summary Safeguard
Statement (SSS)
§
Recruitment Checklist
(where applicable)
§
Informed Consent
Statement (ICS)
§
Authorization for the
Release of Health Information for Research (where applicable)
§
Recruitment
materials, if applicable
§
Protocol
§
Other
supporting documents
§
(3) copies of
Clinical Investigator Brochure (CIB) or package insert for all drugs being used
in the research
§
(1) copy of the
complete grant proposal for NIH-funded research only.* For grant proposals that will apply to
multiple research studies, a one time submission of the proposal is deemed
sufficient.
* If the principal investigator is the recipient of
federal monies to fund his/her research, he/she must include a copy of the
entire grant application for the IRB to review.
If the principal investigator is a sub-contractor or recipient of
federal pass-thru monies, the IRB does not need to see the entire grant
application.
Submit all materials to the Methodist IRB Office,
Academic Affairs – Research, B Building Room 349, 1630 N. Capitol, Methodist
Hospital. All materials must be neatly
typed since they are subjects to federal inspection. For assistance in preparing materials, call
the Methodist IRB Office at 317/962-8240.
IRB-03 meetings are usually held on the 2nd Thursday of each
month, approximately five weeks after the deadline.
IRB Submission Documents
Application Form for
Non-Research Student Projects. This form must be
completed and personally signed by the faculty sponsor.
Application for
Research Not Subject to FDA and Common Rule Definitions of Human Subjects
Research. This form must be completed and personally
signed by the investigator (or in the case of a student project, the faculty
sponsor).
Documentation of Review and
Approval. This form must be completed and personally
signed by the principal investigator.
Summary Safeguard Statement. A response
must be provided for each item. "See Attached" and/or
"n/a" are NOT acceptable responses.
Informed Consent Statement. Careful review
of the Informed Consent Statement Checklist
is important in the preparation of this document.
NOTE: If the research study is a
National Institute of Health (NIH) multicenter clinical trial, a copy of the
NIH-approved sample informed consent document must be submitted as a condition
for review and approval of the local informed consent statement. Any deletion or substantive modification of
the information about risks or alternative procedures contained in the sample
informed consent document must be justified in writing by the investigator and
approved by the IRB.
Authorization
for the Release of Health Information for Research. Careful review
of the Authorization is important in the preparation of this document.
Protocol. All expedited and full review research
applications must include a protocol separate from the Summary Safeguard
Statement in order to receive IRB review.
For NIH studies, the entire grant proposal must also be submitted. The protocol MUST include at a minimum, the
following:
Recruitment
Materials. Any written material or
advertisement to be seen or heard by prospective research subjects and methods
and modes of communication used to recruit research subjects must be submitted
for IRB review and approval. No
advertisement, method, or mode of advertising the research study to subjects
may be employed until IRB approval is granted.
Instruments. Include the
instrument(s) used for questionnaires or surveys, etc.
Clinical Investigator Brochures (CIBs). Three (3) copies
of investigational brochures must be forwarded at the time of submission to the
IRB when investigational drugs or devices are used. Studies involving FDA-approved pharmaceuticals
should either include 3 copies of the package insert or contain within the
protocol a complete description of information included in the package insert
(i.e., toxicities, recommended dosing, etc.).
Recruitment
Checklist and Telephone Scripts. The Recruitment Checklist describes the process and
methods used to identify, recruit or screen subjects into a research study
involving health information. In
addition, telephone scripts used to recruit or screen subjects for eligibility
into a research study must be submitted to the IRB for approval. This script must be included with an
explanation of what will be done with the personal information if the caller
ends the interview or simply hangs up.
See FDA Information Sheets, Recruiting Study
Subjects, B. Receptionist Scripts for additional information. See Recruitment Checklist for more details
regarding the guidelines for using an individual’s health information to identify,
contact and/or recruit subjects into a research study.
§
All documents
must be neatly typed and legible with any acronyms spelled out the first time
they are used.
§
INCOMPLETE
applications will NOT be reviewed by the IRB.
§
The investigator
is responsible for keeping a copy of all documents submitted to the IRB.
§
The SAME title
must appear on the first page of each of these forms:
IRB Actions
Non-Research Student Projects.
The IRB may accept or deny non-research student projects. If the application is denied, a reason for
its denial will be provided.
Research Not Subject to FDA
and Common Rule Definitions of Human Subjects Research. The IRB may accept or deny
this type of research. If the
application is denied, a reason for its denial will be provided.
Research Involving Human Subjects. The IRB may take any of the
following four actions:
Final Approval:
This means that the PI may commence the research only after
receiving written IRB approval indicated by a signed copy of the Documentation
of Review and Approval with a cover letter from RCA or the Methodist IRB
office outlining the additional responsibilities for conducting research at
IUPUI or Clarian.
Provisional Approval: This
means that the PI must respond in writing to provisions requested by the IRB
before final approval can be granted.
RCA or the Methodist IRB office will communicate these provisions to the
investigator by sending a cover letter with an excerpt of the meeting minutes
detailing the IRB’s discussion and requested provisions. Once the responses are reviewed and approved
by the IRB or its designee, the PI may commence the research only after
receiving written IRB approval indicated by a signed copy of the Documentation
of Review and Approval with a cover letter from RCA or the Methodist IRB
office outlining the additional responsibilities for conducting research at
IUPUI or Clarian.
Tabled: This means that the research study was
deferred for reconsideration at a subsequent IRB meeting after the PI has
responded in writing to modifications requested by the IRB.
Disapproved: This means the study cannot be resubmitted in
the same form. The PI will be notified
in writing of reasons for disapproval.
Upon completion of the
review, the investigator will receive a written response from the IRB shortly
after the meeting. Any questions raised by the IRB must be responded to in
writing within sixty (60) days (provisionally approved or tabled studies). No
research activities may be initiated until the PI receives written final approval
from the IRB. The investigator is
responsible for notifying the sponsor if the IRB finds that a device presents a
significant risk to the subjects.
Infectious Agents, Hazardous Materials or Other Chemicals:
For additional information regarding the safe
use and disposal of infectious agents, hazardous materials or other chemicals,
contact the Department of Environmental Health and Safety at 317/274-2005.
Radiation and/or Radioactivity: If this study
involves the use of radiation and/or radioactivity in addition to what is
already used for standard clinical treatment or the subject would receive
radiation exposure only due to participation in the research, approval must
also be obtained from the appropriate radiation committee. Final approval for a research study cannot be
granted until appropriate documentation is received from the radiation safety
committee, if applicable. Further
information and sample risk statements for radiation exposure can be obtained
from the Radiation Safety Office, Clinical Building, Room 159,
317/274-4797. If radioactive materials
are used at Methodist Hospital, no specific radiation approval is required
prior to submission. However, the
Research Review Committee will review the radiation component after submission.
General Clinical Research Center (GCRC): If you will be
using the facilities of the GCRC, University Hospital, Room 5595, further
additional information or submission may be required. Please contact the GCRC at 317/274-4356 to
obtain additional requirements prior to completing IRB submission. You must provide the Center with all
documentation submitted to the IRB, i.e., protocols, amendments, ongoing
reviews, etc.
Midtown Mental Health Clinic: If you will be
recruiting from or conducting any part of your research at Midtown Mental
Health Clinic, please contact Dr. Steve Fekete, Executive Director at
317/554-2710 for information and requirements regarding Midtown approval. Approval from Dr. Fekete is required prior to
initiating the research at the Midtown Mental Health Clinic. This approval must be submitted to the IRB
before final approval of the research can be granted by the IRB.
Veterans Affairs (VA): All
recruitment or research to be conducted at the VA must be approved by an
IUPUI/Clarian IRB prior to submission to the VA for approval by their research
office. If you will be recruiting from
or conducting any part of your research at the VA facilities, the following is
to be included in the IRB submission:
a. Indicate
recruitment or research will be conducted involving VA subjects and/or at the
VA (see Section II of the summary safeguard statement);
b. Include
the VA Form 10-1086 Informed Consent Statement.
Further information and requirements regarding VA
approval and necessary forms may be obtained by calling the VA Research Office
at 317/554-0000, Extension 2526.
Wishard Hospital and Clinics: All
studies to be conducted within Wishard Health Services (including the hospital,
OB/GYN clinic and Regenstrief clinics) that involve Wishard patients, services,
or facilities, must be approved by Wishard administration prior to the research
commencing.
Approval is NOT required for studies being conducted
ONLY in the primary care clinics using ResNet or for data extraction studies
(i.e. those that do not require any direct patient contact or the use of
Wishard services or facilities) that are conducted by the Regenstrief
Institute. In these cases, separate approval
processes and/or oversight already exist.
Wishard Health Services approval may be obtained by
emailing the summary safeguard statement to Dr. Lisa Harris at leharris@iupui.edu. Flag this e-mail as URGENT with the subject
line of the email stating “research approval needed.” You do not need to wait until you receive IRB
approval of the summary safeguard statement before forwarding. In fact,
simultaneous submission to Dr. Harris and the IRB is preferred.
It is Dr. Harris’s intention to respond within 3
days. If you do not hear back within 3
days, resend your information to her. If
you receive an “out of office” notice, please forward your request to Jessica
Barth, Dr. Harris’s designee, at Jessica.barth@wishard.edu.
Scientific
Review Committee: If you will be involving cancer patients
in your study, approval from the Scientific Review Committee (SRC) may be
required. The only exception is if you
are doing a retrospective chart review involving cancer patients, which does
NOT require SRC approval. Please contact
the SRC at 317/274-0934 for additional information. You must receive SRC approval prior to
submitting your research application to the IRB. This approval must be included with your IRB
submission paperwork. At Methodist, this
is not a requirement, as the Research Review Committee will be reviewing the
study after study submission.
PRINCIPAL INVESTIGATOR AND FACULTY SPONSOR ELIGIBILITY
AT IUPUI/CLARIAN
These guidelines
are applicable for determining whether an individual is eligible to serve as a
principal investigator for a human subjects research study or a faculty sponsor
for student projects. Because human
subjects research and student projects are being conducted and overseen by both
faculty at IU and medical staff at Clarian, please refer to the appropriate
guidelines below for determining eligibility.
Principal
Investigator: The responsible leader of a team of
investigators (and research team), who has the ultimate responsibility for the
conduct of the research.
Faculty
Sponsor: Full or
part-time faculty employed by IUPUI/Clarian who engage in classroom
instruction, supervise on or off campus internships, clinical experiences or
practica, or mentor students who are conducting independent projects.
Principal
Investigator and Faculty Sponsor Eligibility at IU:
The following
academic appointee classifications ARE eligible to serve as principal
investigators and/or faculty sponsors:
1. FACULTY with the following titles: (1) Special Professorship; (2) Professor; (3)
Associate Professor; (4) Assistant Professor; and (5) Instructor.
2. LIBRARIANS with the following titles: (1) Librarian; (2) Associate Librarian; (3)
Assistant Librarian; and (4) Affiliate Librarian.
3. ADMINISTRATIVE OR SPECIAL STATUSES with the following titles: (1) President; (2) Vice
President; (3) Chancellor; (4) Vice Chancellor; (5) Dean; (6) Associate Dean;
(7) Assistant Dean; (8) Chairman; (9) Director; (10) Acting 1 to 5; (11)
Visiting; (12) Adjunct-Compensated; (13) Emeritus (Case-by-Case); (14)
Part-Time; and (15) Clinical.
4. RESEARCH STAFF with the following titles: (1) Senior Scientist; (2)
Associate Scientist; and (3) Assistant Scientist.
The following
academic appointee classifications are NOT eligible to serve as
principal investigators and/or faculty sponsors (*see special exceptions
below):
1. OTHER INSTRUCTIONAL STAFF with the following titles: (1) Lecturer; (2)
Associate; (3) Assistant; and (4) Teacher.
2. PROFESSIONAL STAFF with the following title: Health Center Physician.
3. RESEARCH STAFF with the following titles: (1) Research Associate;
(2) Senior Scholar; (3) Associate Scholar; (4) Assistant Scholar; and (5) Post
Doctoral Fellow.
4. STUDENT ACADEMIC APPOINTMENTS with the following titles: (1) Associate Instructor;
(2) Faculty Assistant; (3) Graduate Assistant; (4) Student Counselor; (5)
Academic Intern; and (6) Research Assistant.
* Individuals in
schools other than the Schools of Medicine, Nursing, and Dentistry, desiring to
serve as principal investigators or faculty sponsors, must either meet the
eligibility requirements as outlined above or must receive special dispensation
from their School’s Chair.
Principal
Investigator Eligibility at Clarian/Methodist. Physicians must be a member of the Clarian
medical staff ("Active" status, "Associate" status, or
"Provisional" status), as verified by the Medical Staff
Office. Non-physician eligibility requests,
(examples: physical therapists, pharmacists, nurses, other Clarian
staff), are approved on a case-by-case basis. In these
cases, a letter of approval is required from the department head
or upline official.
Other
eligibility considerations (not included above) are as follows:
a.
Student projects
must be submitted to the IRB by an eligible principal investigator or faculty
sponsor.
b.
Any principal
investigator in the department of medicine who is submitting to the IRB for the
first time must identify a mentor within their department and submit a letter
from that individual demonstrating their support.
c.
The eligibility
of emeritus faculty and faculty on sabbatical will be considered on a
case-by-case basis. Among the factors to
be considered are location and nature of the research, relation of research to
the faculty member's regular University assignment, etc.
d.
Adjunct faculty
(not compensated) are eligible when the research is a function of the adjunct
relationship and for which the school assumes responsibility.
e.
Other special
status appointments, e.g., non-paid visiting and non-paid clinical appointees, alone
are not necessarily considered eligible.
f.
When an IU
employee is doing research on behalf of another organization, e.g., in a
consultant relationship with compensation provided by the other institution or
in a student status at another institution (i.e., not IU), the responsibility
for the review is with the other organization/institution.
Appendix B
INDIANA UNIVERSITY
PROTOCOL REVIEW PROCEDURES
for
HUMAN SUBJECTS
|
Campus
or Unit |
Proposal Transmittal |
Initial Protocol Review |
Certification
of
Status |
Continuing Reviews Amendments, and
All Similar Documentation |
|||||
|
|
|
|
At
Proposal Submission (Pending/Approved) |
Follow-up,
Approvals and
Renewals |
|
|
|||
|
|
|
|
|
|
|
|
|||
|
All
IUB* |
IUB |
IUB |
IUB |
IUB |
IUB |
|
|||
|
Medical
Sciences/IUB |
IUPUI |
IUPUI |
IUPUI |
IUPUI |
IUPUI |
|
|||
|
All
IUPUI |
IUPUI |
IUPUI |
IUPUI |
IUPUI |
IUPUI |
|
|||
|
Regional
Centers for Medical
Education** |
IUPUI |
IUPUI |
IUPUI |
IUPUI |
IUPUI |
|
|||
|
Columbus
Center |
IUPUI |
IUPUI |
IUPUI |
IUPUI |
IUPUI |
|
|||
|
Purdue
University Pharmacy
at IUPUI |
Purdue |
IUPUI |
Purdue |
Purdue |
IUPUI |
|
|||
|
Regional
Campuses |
IUB |
Regional
Campuses |
IUB |
Regional Campuses |
Regional Campuses |
|
|||
|
Central
System |
IUB |
IUB |
IUB |
IUB |
IUB |
|
|||
|
|
|
|
|
|
|
|
|||
NOTE: This chart applies to all research or
training protocols involving human subjects, for funded or non-funded
projects. Active committees are found
only on campuses where needs exist.
PROTOCOLS
INVOLVING HUMAN SUBJECTS WILL BE REVIEWED ON A CAMPUS SPECIFIC
BASIS WITH THE EXCEPTION OF THE SCHOOL OF MEDICINE. All School of Medicine protocols, including
the Regional Centers for Medical Education, will be reviewed by the IUPUI
IRB. Campus specific is defined as the
campus where the faculty applicant is located.
Other variables may require that a decision to modify a normal procedure
be made by the campus research administration offices representing the campuses
involved.
*
Except for Medical Sciences
** Lafayette and Muncie Centers are not
processed through IU
Appendix
C
|
Checklist
for Determining Whether an Activity Requires Review by the IUPUI/Clarian IRB |
|
1. If BOTH
of the following are true, your activity involves research: The activity is a systematic investigation[i],
including research development, testing and evaluation. The activity is designed to develop or contribute to generalizable
knowledge[ii]. 2. If EITHER
of the following are true, your activity involves human subjects: The activity involves a living individual
about whom an investigator (whether professional or student) conducting
research obtains data through intervention[iii]
or interaction[iv]
with the individual. The activity involves a living individual
about whom an investigator (whether professional or student) conducting
research obtains identifiable[v]
private information[vi]. 3. If ALL of
the following are true, your activity is subject
to FDA regulations: The activity is an experiment. The activity involves one or more of the
following test articles (foods or dietary supplements that bear a nutrient
content claim or a health claim, infant formulas, food and color additives,
drugs for human use, medical devices for human use, biological products for
human use, electronic products); Any of the following are true: the research
involves using the test article with one or more participants, the research
is being done as part of an IND or IDE submission, the data may be submitted
to the FDA, or the data may be held for inspection by the FDA. If your activity involves research and human
subjects and/or is subject to FDA
regulations (as defined above), your activity requires a research
submission to the IUPUI/Clarian IRB.
Please see the IRB Instruction Packet for additional information on
how to submit a research study. If your activity does NOT involve research and human subjects and/or is NOT subject to FDA regulations (as
defined above), please continue to section 4 to determine if another type of
IRB submission is required. 4. If ANY of
the following are true, your activity requires submission to the
IUPUI/Clarian IRB: Your activity does NOT involve research, BUT
your activity is a student project that may place individuals at risk and involves a vulnerable population
(i.e. children or adolescents, pregnant women and fetuses, prisoners, people
who are mentally disabled or those with impaired decision-making capacity, or
human in vitro fertilization). Please submit the Non-Research Student
Project Application Form. Your activity involves research with one or
more deceased individuals. Please
submit the Application for Research
not Subject to FDA or Common Rule Definitions of Human Subject Research. Your activity involves research with human
subjects, BUT the research data is
derived from a Limited Data Set[vii]
or is De-identified[viii]
data created from Protected Health
Information (PHI)[ix]
from a HIPAA covered entity[x]. Please submit the Application for Research not Subject to FDA or Common Rule
Definitions of Human Subject Research. Your activity involves research with coded
private information or biological specimens.
Please submit the Application
for Research not Subject to FDA or Common Rule Definitions of Human Subject
Research. If your activity does not involve any of the above
criteria, your activity does NOT
require submission to the IUPUI/Clarian IRB. This checklist is meant to assist faculty, staff,
and others in determining whether an activity requires review by the
IUPUI/Clarian IRB. Please use the Additional Information page for
further details on the above definitions.
If you have any questions after going through this checklist, please
contact the Research Compliance Administration office at (317) 274-8289. |
[i] Systematic
Investigation typically involves a predetermined method for studying a
specific topic, answering a specific question(s), testing a specific
hypothesis(es), or developing theory.
Examples: observational studies, interview or survey
studies, group comparison studies, program evaluation, test development,
interventional research.
[ii] Develop or
contribute to generalizable knowledge typically requires that results (or
conclusions) of the activity are intended to be extended beyond a single
individual or an internal program.
Examples: activities where there is an intent to
publish the results in a peer-reviewed journal or to present at a regional or
national meeting, as well as, theses or dissertation projects conducted to meet
the requirements of a graduate degree.
[iii] Intervention
includes both physical procedures and manipulations of the living individuals
or the living individuals' environments.
[iv] Interaction
includes communication or interpersonal contact between the investigator (or
research team) and the living individual.
Examples: interviews, questionnaires, surveys,
observations, manipulation of subject behavior, diet, or environment, physical
measurements, specimen collection (e.g. blood tissue), administration of
experimental drugs or devices.
[v] Information is considered Identifiable if (1) the identity of the individual from whom the
information was obtained is ascertained or may be readily ascertained by the
investigator; or (2) the identify of the individual from whom the information
was obtained is associated or may be readily associated with the information.
[vi] Private
information includes information about behavior that occurs in a context in
which the individual can reasonably expect that no observation or recording is
taking place or information that has been provided for specific purposes that
the individual can reasonably expect will not be made public (e.g., medical
record, employee or student records).
Examples
of individual identifiers include the subject's name, address, phone number,
social security number, medical record number, student or employee
identification number, or in some cases, the combination of data such that they
can identify a single individual through deductive reasoning. For example, data about employer, job title,
age and gender may not individually identify a subject, but when combined,
could in certain cases, identify a specific individual.
If
the information cannot be linked to a living individual, or is considered
public or is given with the expectation that it will be made public and that it
will be linked to the individual (e.g. biography, news story), then it would
not be considered private identifiable information. For example, use of a publicly available data
set that does not contain any
identifiers or codes linked to individuals does not involve human subjects research. However, use of a publicly available data set
that does contain identifiers or
codes linked to individuals does
involve human subjects research (that would be considered exempt).
[vii] Limited Data Set – This set of data excludes
facially identifiable information, but still includes some identifiable
information. As a result, the data is
still “identifiable” and may be used for limited purposes, including research,
public health or healthcare operations as long as there is a data use agreement
with the recipient of the limited data set.
A
limited data set must exclude 16 specified identifiers that are listed
in the Rule including: name, street address, telephone and fax numbers, email
address, social security number, certificate/license number, vehicle
identifiers and serial numbers, URL’s and IP addresses, and full face photo’s
and any other comparable images.
The
limited data set could include the following identifiable
information: admission, discharge, and
service dates, date of death, age, (including age 90 and older); and the five
digit zip code.
[viii] De-Identified – Health information is
de-identified if there is no reasonable basis to believe that the data can be
used to identify an individual, or if the provider has no reasonable basis to
believe it can be used to identify the individual. All of the following 18 identifiers must be
removed for the data to be considered de-identified: name, all geographic subdivisions smaller
than a State including street address, city, county, precinct, zip codes and
equivalent geocodes,(except for the initial 3 digits of a zip code if more than
20,000 people reside in the area), all dates including birthdays (other than
the year) and ages over 89, phone numbers, fax numbers, email addresses, social
security numbers, medical record
numbers, health plan beneficiary numbers, account numbers, certificate/license
numbers, vehicle identifiers and serial numbers (including license plate #),
device identifiers and serial #’s, URLs, IP addresses, biometric identifiers,
full face photographic images and any comparable images, any other unique
identifier, characteristic or code.
Note: Other demographic
information, such as gender, race, ethnicity, and marital status are not
included in the list of identifiers that must be removed.
[ix] Protected
Health Information (PHI): Health information, including demographic
information collected from an individual, and (1) is created or received by a
health care provider, health plan, employer, or health care clearinghouse; and
(2) relates to the past, present, or future physical or mental health or
condition of an individual; the provision of health care to an individual.
[x] Covered Entity: Health plans, health care clearinghouses, and health care providers who transmit any health information in electronic form in connection with a HIPAA required standard transaction–typically providers that bill electronically.