Human Subjects Forms &
Procedures Update
1
AAHRPP RE-ACCREDITATION CHANGES
NEW AND IMPROVED FORMS AND SOPS
AAHRPP Accreditation Overview
2
 The Association for the Accreditation of Human
Research Protection Programs (AAHRPP) offers
accreditation to research organizations that provide
comprehensive protections to research participants.
 Process




Voluntary, Peer-driven, and educational
Renews every three years
Application process to address AAHRPP requirements
Site-visit
Changes to Forms and Procedures
3
 Why are changes being made?
 Comply with AAHRPP accreditation standards and requests
 Consolidation of the Indianapolis and Bloomington Human
Subjects Office
 To un-complicate forms
 Revisions/updates haven’t been done since May 2009
Major Changes
4
 Merger of the HRPP



IUPUI and IUB merged
IUPUI/Clarian changed to IU on forms
PI’s can use any IRB, no longer campus specific
 New office name: IU Human Subjects Office



Research Compliance Administration changed to Human Subjects
IU Human Subjects Office – Biomedical (Indy)
IU Human Subjects Office – Behavioral (IUB)
 All forms and SOPs updated

See Summary of Changes for abbreviated list on HSO website:
http://researchadmin.iu.edu/HumanSubjects/hsdocs/Sum
mary+of+Changes+-+All+Documents.pdf
New Human Subjects Website
5
 Vision

Single HRPP website
 Updates


Instruction Packet no longer exists
See website pages and guidance documents for information
 Timeline

“Live” on January 15th with new forms and new SOPs
 New Links


Human Subjects Home:
http://researchadmin.iu.edu/HumanSubjects
Human Subjects Forms:
http://researchadmin.iu.edu/HumanSubjects /hs_forms.html
Dates to Know
6
 January 15th
 New forms are available for use on the Human Subjects
website
 March 15th
 New forms are required for applicable submissions
New Studies
 Continuing Reviews – Open to Enrollment
 Amendments, as applicable

Summary Safeguard Statement
7
 Important changes:

Section I –


Clarified instruction on the form; reminder: lay language
Section II – HIPAA
Covered Entity Checklist is not automatically required
 Refer to HIPAA form


Section III – Performance Site
Reworked to include IUB, IUPUI, etc.
 Read the section for familiarity with changes


Section IV – Subject Population
Subjects Outside of US - Transnational Research – will be prompted
to complete separate request form
 New SOP coming soon
 Clarified Number of Subjects to be involved in the research

Summary Safeguard Statement
8
 Important changes continued:
 Section V – Recruitment



Section VI – Study Procedures




Is PI lead on Multi-Center Clinical Trial
 Doesn’t mean conducting at multiple locations locally
Section IX – Data Safety Monitoring Plan


Describe frequency and duration
Attach ancillary materials
Section VII - Risk and Benefit sections now combined to Risk/Benefit
Ratio Section
Section VIII – Protection Procedures


If subject to HIPAA, go straight to the HIPAA & Recruitment Checklist
Clarified what competing studies means and how to handle
 More guidance coming from Executive Committee
No Changes
Section X – Payment

No Changes
Summary Safeguard Statement
9
 Important changes continued:
 Confidentiality and Safeguards section (was Section X prior)
has been removed from all forms


Section XI – Informed Consent Process


Minor Updates – review form
Section XVI and XVII – Additional Reviews


Misleading, caused confusion and inconsistency; raised potential
for noncompliance
Revised – review form
Section XVIII – Federal Funding
Condensed
 Ensure copies of proposal and sample consent are sent with
submission

Summary Safeguard Statement
10
 Important changes continued:
 Section XIV – Investigational Test Articles
Added - If you think the device/drug does not require an
IDE/IND, fill out the checklist to confirm, or submit the FDA
confirmation of status
 Question whether IU-affiliated investigator holds the IND/IDE
 Complete risk assessment for NSR devices
 NSR devices are still investigational


Section XV – Co-investigator section and COI section are
REMOVED

Separate form now
Investigator List
11
 New form, required for ALL submissions


Regardless of level of review (exempt, expedited, full Board)
Not required for non-human subjects research or student projects
 This information removed from SSS

SSS won’t be connected to co-investigator list or updates
 Includes COI section

Additional question added to form (discussed during COI section)
 When submitting Co-investigator updates, include:


Co-investigator update form
Investigator list (updated with track changes)
HIPAA & Recruitment Checklist
12
 New form



Moved from SSS to new form
Formerly the Recruitment Checklist and supplemented with other
HIPAA information and considerations
Intended to reduce redundancy: all HIPAA/recruitment information
located on one form

Section I – Recruitment Section
 Competing Studies section
• More guidance coming from Executive Committee
Section II – Same
 Section III – Authorization section
 Previously in SSS
 Waivers of authorization:

• Recruitment vs. Participation
HIPAA & Recruitment Checklist
13
Template language for VA Waivers for Recruitment and Informed
Consent available from VA R&D office
 When you will receive a signed Checklist back from HSO office:
 At initial review: if a waiver of authorization is approved by the
IRB
 With amendments: if ANY changes are made to the HIPAA &
Recruitment Checklist
 With CR: no.
 Authorizations for recruitment:
 Only one authorization form is necessary
 Subject should sign prior to recruitment
 Additional signature at time of consent not necessary

Child Request Form
14
 New process for requesting waivers of assent
 Based on capability
 Waivers not required for children incapable of assent
 Also see SOP on Vulnerable Populations
Waiver of Assent for Children
Capable of
Assent
Not Capable
of Assent**
Requires Assent of Child
or Waiver of Assent*
Does not require Waiver
or Assent from Child
Waiver Justification:
1. Minimal Risk or
2. Holds Prospect of Direct Benefit
PI needs to justify why Children are not
capable of Assent
- Ex: Age, Limited Capacity, etc.
*Requires IRB approval
of Waiver request
**Requires IRB concurrence
with the justification
15
Informed Consent Statement
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 New Informed Consent template includes new stamp
template

Will start to see new stamp on word version of forms
 New IU IRB Guidance on Informed Consent Statement




Templates are now embedded in the guidance form
Found on HSO website:
http://researchadmin.iu.edu/HumanSubjects /hs_forms.html
Template includes required language and optional sections as
needed
SOP separates what is required on consent and what is not


Example: Compensation for Injury section
Study number included on consent is helpful for reviewers
Authorization Form(s)
17
 Healthy Subjects
 Use when medical charts will not be accessed; will only be
collecting research data directly from subject
 Non-Healthy Subjects
 Use when collecting information from some or all of subject’s
health records
 VA
 Specific VA Template
Transnational Research Form
18
 For use when enrolling subjects outside of the US.
 Requires information on
 Local IRB review where the research will be conducted
 Local context (social, economic, political, etc.) that may impact
research
 Communication between PI and local investigators,
community leaders, etc.
Other Updates
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 Exempt Studies
 Documentation of Review and Approval now required with
submission
 Amendment form
 Now required for exempt, expedited, and full Board
submissions
 Noncompliance, Prompt Reporting, and Misc.
General Information form

Signed upon approval of the item
 Continuing Review form
 Category 9
Minutes Template
20
 New format for IRB Board minutes
 Updated to reflect new assent process
 Minimal risk vs. greater than minimal risk
determination:


For ALL full Board new studies
For all full Board CRs
SOP Updates
21
 Overarching changes
 Added SOP Intro
 Added new sections to each SOP
VA
 FDA
 HIPAA
 And other including DOD, DOJ and DOE, BOP

SOPs with Minor Changes
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 Introduction to SOPs
 New Section: Mission Statement, Charter, Scope
 IRB Operations

Continuing Review expiration date
The study expires at 11:59pm on the IRB approved expiration date
 EXAMPLE: If the study was approved on July 20, 2010, the
investigator can conduct study activities through 11:59pm on July
19, 2011
 Approval stamp: continuing review date is now expiration date

 Confidentiality and Privacy

HIPAA is reorganized to be independent section
SOPs with Minor Changes
23
 Definitions
 Changes and Additions made, review for updates.
 Exempt and Expedited New Study Process
 Added IRB staff can grant exemptions
 Amendment form is required for all exempt changes now
 Investigator Responsibilities – New SOP
 Combined PI, Research Personnel, Investigator Qualifications SOPs
 NOW Applies to all investigators (Co and Principle)
 Updates: CITI, DOD, DOJ
 Planned Emergency Research
 Separated from Research with Investigational Test Articles SOP
 No changes to communicate
 Emergency Use of Investigational Test Articles
 VA – can’t do emergency research at the VA, can receive the
intervention as a patient but not as a research subject
Auditing
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24
 Auditing SOP updated to more accurately reflect the
current process


Now includes language regarding more than one auditor
Updated to IU language from IUPUI/Clarian and other new SOP
format changes
 SOP Covers Three Major Areas Regarding Auditing

How PIs/studies are chosen for audit


Describes the general audit process from notification, to site visit, to
audit report, response to findings, and then IRB Review


Directed and Scheduled
 Changed to require approval from Shelley for Scheduled Audit List
instead of the Executive Committee
Changed the requirement that noncompliance noted during an audit
must be reported by the PI
Responsibilities related to external audits
Genetic Information Nondiscrimination Act
(GINA)
25
New SOP
 Guidance for studies involving testing or tracking of a
particular disease or disorder in an individual’s family



Includes what needs to be on consent document and
considerations to be made by Board for approval (what protections
need to be in place when using genetic information)
Consent language (applies to VA as well):
This research follows the Genetic Information Nondiscrimination
Act (GINA), a federal law which generally makes it illegal for
health insurance companies, group health plans, and most
employers to request the genetic information we get from this
research and discriminate against you based on your genetic
information
Genome-Wide Association Study (GWAS)
26
New SOP
 Provides guidance on studies that intend to identify
common genetic factors that influence health and disease
 New form


What it is, when to use it, when to submit
 These studies will be identified as GWAS studies – our office
fills in before issuing approval
 Prospective asking to submit to GWAS or Retrospective we’ve
already collected and now we want to submit to study
• Specific determinations the IRB must make associated with this now
• On form – text boxes: IRB Certification and Institutional
Certification
• Say appropriate use and explicit use of specimens
Humanitarian Use Devices (HUD )
27
New, separate SSS for HDE (HDE SSS)
 FDA guidance included
 Need to include product information and FDA letter of
approval with submission
 Two directions

Clinical purposes only
 Submit HUD Application
 Clinical Consent only (no separate research consent)
 Can go Expedited on continuing review, but not initial review
 Clinical + investigation
 If data is to be collected, study needs “regular” IRB documents
(SSS, research consent, etc.)

Informed Consent
28



SOP Reorganized
Additional VA guidance (not new, additions have been
required)
FERPA
Guidance on when you can access student records; IRB review is only
concerned when using student records for research
 If researcher has legitimate access to student records, consent not
needed
 Academic researchers do have legitimate access
 If intent is for IU purposes to improve, report, etc. it is consistent
with FERPA
 School official definition
 IRB can make determination regarding whether the researcher has
legitimate access

Informed Consent – Short Form
29
 Document that provides basic elements of informed
consent: non study-specific information, includes info
that is relevant to all research

Languages available at IU : English, Arabic, Chinese, French,
Russian, Spanish, Vietnamese
 When they can be used:
 Study participant or LAR does not speak English
 Speak only a language not anticipated for study population
 Appropriate consent form in their language has not been
approved by the IRB
 There is not enough time or demand for IRB to approve a
consent in their language
Informed Consent – Short Form
30
 How they are used
 Short Form consent document should be translated in a
language understandable and given to subject with study
summary document (e.g. English consent document)
 Signatures
Has to be a witness
 Subject signs the short form
 Witness signs short form and copy of study summary English version
(e.g. English consent)
 Study team member signs English version

 IRB Approval Requirements
Report use of short form at time of continuing review
 Board will determine trends and whether a translated consent form is
required

Transnational Research
31
 New SOP
 Provides procedures on conducting research outside
of the US and enrolling populations outside of the
US.
 Guidance document and Transnational Research
form are also available
Vulnerable Populations
32


If study population includes a vulnerable population, but
members of the vulnerable population cannot be explicitly
identified, then the Request form does not need to be
completed.
Research with Children (review)
Request for waiver of assent is not necessary if the population of
children is not capable of assent
 PI provides justification as to why requested population of children
are not capable of assent
 Any questions, please contact our office.


Research with Prisoners
When using prisoners as a study population, the research has to meet
one of the four categories of prisoner research
 Expedited review of research involving prisoners is allowed

Conflict of Interest and IRB:
Principles and Processes
33
COMPLIANCE ADMINISTRATION
AND
RESEARCH ETHICS, EDUCATION, AND
POLICY
OFFICE OF RESEARCH ADMINISTRATION
Table of Contents
34
 Individual Conflict of Interest
 Principles/Mission
 Process: Flow Chart
 Institutional Conflict of Interest
Principles /Mission
35
 CoI: Objectivity in Research

PHS: CFR 42 Part 50 Subpart F. Responsibility of Applicants
for Promoting Objectivity in Research for which PHS Funding
is sought.

FDA: CFR 21 Part 54. Financial Disclosure by Clinical
Investigators.
Principles /Mission
36
 IRB: Protection of Human Research
Subjects

PHS: CFR 45 Part 46. Protection of Human Subjects

FDA: CFR 21 Part 50. Protection of Human Subjects.
Point of Intersection:
37
Protecting human
subjects when there
is a conflict of
interest
AAHRPP Standards
38
 Standard I-6. Organization has and follows written
policies/procedures to ensure that research is
conducted so that financial CoIs are identified,
managed and minimized or eliminated


I.6.A. … to identify, manage, and minimize or eliminate
financial CoIs of the Organization that could influence the
conduct of the research or integrity of HRPP
I.6.B. … to identify, manage, and minimize or eliminate
financial CoIs of researchers and research staff that could
influence the conduct of the research or integrity of HRPP.

Organization works with IRB
Process: Flow Chart
39
Process: Flow Chart
40
 Disclosures
 Annual Disclosure
 All faculty and other researchers
 Disclosure

based on IU policy
Based on PHS/NSF standards
 Updates
as appropriate
 ORA routing sheet ask for disclosure of any potential
CoI’s
All Key Personnel
 As per specific project

Process: Flow Chart
41
 IRB CoI Disclosure
 All Researchers conducting human subjects research must
complete IRB protocol with questions regarding CoI.
 Disclosure
Based on FDA standards
 For all Key Personnel
 Asks for interests related to a specific project

Process: Flow Chart
42
 CoI Management
 CoI Committee reviews:
To determine if financial interest constitutes CoI
 If no, process stops
 If yes, next step
 If management plan is necessary
 If no, process stops
 If yes, management plan developed and shared with IRB

Process: Flow Chart
43
 IRB reviews management plan
 Accepts as sufficient to protect human subjects
 Adds additional restrictions to protect human subjects
Process: Flow Chart
44
 Common elements of management plan
 Public disclosure of financial interests
 Monitoring of research by independent reviewers
 Modification of research plan
 Disqualification from participating in all or portion of research
 Severance of relationship that create conflict
Institutional Conflict of Interest
45
 Definition: Conflicts of interest based on either the
financial interests of the institution itself or of its
officials acting in leadership or supervisory positions,
are of special concern in the conduct of human
subjects research (AAMC).
 Specifically relevant to:



Intellectual Property (IP) and Institutional Investments
Gifts
Financial interests of Senior Administrative Officials
Institutional Conflict of Interest
46
 Intellectual Property (IP) and Institutional
Investments


All IU IP and investments of IURTC held by and managed by
IURTC
IURTC
Committed in principle and practice to respecting and maintaining
autonomy of IU’s research integrity and operations, in general,
and to its human research protection program and processes, in
particular.
 Passed resolution committing itself to non-interference with IU’s
program and processes for protecting human subjects in research.

Institutional Conflict of Interest
47
 Major Gifts and investments
 All major gifts to IU and investments of IUF are held by and
managed by the IUF
 IUF
Committed in principle and practice to respecting and maintaining
autonomy of IU’s research integrity and operations, in general,
and to its human research protection program and processes, in
particular
 Passed resolution committing itself to non-interference with IU’s
program and processes for protecting human subjects in research.

Institutional Conflict of Interest
48
 Financial interests of Senior Administrative Officials
 Such officials must comply with:
IU Financial Conflict of Interest Policy
 Indiana State Law on Conflict of Interest (35-44-1-3)

Institutional Conflict of Interest
49
 Disclosure of I-CoI
 Investigators identify, to the best of their knowledge, if a
proposed project involves IU IP or IU gifts
 IURTC and IUF provide relevant information as requested by
IRB and CoI Committee
Institutional Conflict of Interest
50
 Review of I-CoI
 IRB staff and IRB evaluate and review institutional significant
financial interests related to conduct of human subjects
research as they do individual significant financial interests.
Questions?
51
Biomedical Human Subjects Office
Office of Research Administration
Indiana University
317.274.8289
[email protected]
www.researchadmin.iu.edu
Behavioral/Social Sciences Human Subjects Office
Office of Research Administration
Indiana University
812.856.4242
[email protected]
www.researchadmin.iu.edu
Research Ethics, Education, & Policy Office
Office of Research Administration
Indiana University
812.855.0656
[email protected]
www.researchadmin.iu.edu
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Human Subjects Staff Retreat