1. Human Subjects Forms & Procedures Update
AAHRPP Re-accreditation changes
New and improved forms and sops

2. AAHRPP Accreditation Overview
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
HSO

3. Changes to Forms and Procedures
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
HSO

4. Major Changes 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:
Shelley

5. New Human Subjects Website
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:
Human Subjects Forms: /hs_forms.html
HSO

6. Dates to Know January 15th March 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

7. Summary Safeguard Statement
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

8. Summary Safeguard Statement
Important changes continued:
Section V – Recruitment
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
Section VI – Study Procedures
Describe frequency and duration
Attach ancillary materials
Section VII - Risk and Benefit sections now combined to Risk/Benefit Ratio Section
Section VIII – Protection Procedures
Is PI lead on Multi-Center Clinical Trial
Doesn’t mean conducting at multiple locations locally
Section IX – Data Safety Monitoring Plan
No Changes
Section X – Payment

9. Summary Safeguard Statement
Important changes continued:
Confidentiality and Safeguards section (was Section X prior) has been removed from all forms
Misleading, caused confusion and inconsistency; raised potential for noncompliance
Section XI – Informed Consent Process
Minor Updates – review form
Section XVI and XVII – Additional Reviews
Revised – review form
Section XVIII – Federal Funding
Condensed
Ensure copies of proposal and sample consent are sent with submission
amy

10. Summary Safeguard Statement
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
amy

11. Investigator List 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)
amy

12. HIPAA & Recruitment Checklist
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

13. HIPAA & Recruitment Checklist
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
amy

14. Child Request Form New process for requesting waivers of assent
Based on capability
Waivers not required for children incapable of assent
Also see SOP on Vulnerable Populations

15. Waiver of Assent for Children
Capable of Assent
Requires Assent of Child
or Waiver of Assent*
Waiver Justification:
1. Minimal Risk or
2. Holds Prospect of Direct Benefit
*Requires IRB approval
of Waiver request
Not Capable
of Assent**
Does not require Waiver
or Assent from Child
PI needs to justify why Children are not capable of Assent
- Ex: Age, Limited Capacity, etc.
**Requires IRB concurrence
with the justification

16. Informed Consent Statement
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: /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

17. Authorization Form(s)
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

18. Transnational Research Form
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.

19. Other Updates Exempt Studies Amendment form
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

20. Minutes Template 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
Human Subjects Office

21. SOP Updates Overarching changes Added SOP Intro
Added new sections to each SOP VA
FDA
HIPAA
And other including DOD, DOJ and DOE, BOP
Human Subjects Office

22. SOPs with Minor Changes
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
Human Subjects Office

23. SOPs with Minor Changes
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
Human Subjects Office

24. Auditing SOP Covers Three Major Areas Regarding Auditing24
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
Directed and Scheduled
Changed to require approval from Shelley for Scheduled Audit List instead of the Executive Committee
Describes the general audit process from notification, to site visit, to audit report, response to findings, and then IRB Review
Changed the requirement that noncompliance noted during an audit must be reported by the PI
Responsibilities related to external audits
Human Subjects Office

25. Genetic Information Nondiscrimination Act (GINA)
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
Human Subjects Office

26. Genome-Wide Association Study (GWAS)
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
Human Subjects Office

27. Humanitarian Use Devices (HUD )
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.)
Human Subjects Office

28. Informed Consent 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
HSO

29. Informed Consent – Short Form
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
Human Subjects Office

30. Informed Consent – Short Form
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
Human Subjects Office

31. Transnational Research
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

32. Vulnerable Populations
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
Human Subjects Office

33. Conflict of Interest and IRB: Principles and Processes
Compliance Administration
and
Research Ethics, Education, and Policy
Office of Research Administration
John B.

34. Table of Contents Individual Conflict of Interest
Principles/Mission
Process: Flow Chart
Institutional Conflict of Interest
John B.

35. CoI: Objectivity in Research
Principles /Mission
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.
John B.

36. IRB: Protection of Human Research Subjects
Principles /Mission
IRB: Protection of Human Research Subjects
PHS: CFR 45 Part 46. Protection of Human Subjects
FDA: CFR 21 Part 50. Protection of Human Subjects.
John B.

37. Point of Intersection:
Protecting human subjects when there is a conflict of interest
John B.

38. AAHRPP Standards
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
John B.

39. Process: Flow Chart
John B.

40. Process: Flow Chart Disclosures All faculty and other researchers
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
John B.

41. Process: Flow Chart 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
John B.

42. Process: Flow Chart 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 yes, management plan developed and shared with IRB
John B.

43. Process: Flow Chart IRB reviews management plan
Accepts as sufficient to protect human subjects
Adds additional restrictions to protect human subjects
John B.

44. Process: Flow Chart 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

45. Institutional Conflict of Interest
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
John B.

46. Institutional Conflict of Interest
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.
John B.

47. Institutional Conflict of Interest
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.
John B.

48. Institutional Conflict of Interest
Financial interests of Senior Administrative Officials
Such officials must comply with:
IU Financial Conflict of Interest Policy
Indiana State Law on Conflict of Interest ( )
John B.

49. Institutional Conflict of Interest
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
John B.

50. Institutional Conflict of Interest
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.
John B.

51. Questions? Biomedical Human Subjects Office
Office of Research Administration
Indiana University
Behavioral/Social Sciences Human Subjects Office
Research Ethics, Education, & Policy Office