1. Is this Research? Exempt? Expedited?
HRPP 201
March 2009
Is this Research? Exempt? Expedited?
Presented by:
Marisue Cody, PhD
Deputy Director, PRIDE
Is this Research? Exempt? Expedited?

2. Objectives Evaluate if the activity is research
HRPP 201
March 2009
Objectives
Evaluate if the activity is research
Evaluate if a study meets exempt criteria
Evaluate if a study meets expedited criteria
Is this Research? Exempt? Expedited?

3. HRPP 201
March 2009
Research
… a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to “generalizable” knowledge.
(38 CFR d)
Widespread information…
Is this Research? Exempt? Expedited?

4. HRPP 201
March 2009
When is it a QA Activity?
QA activities that are designed solely for internal program evaluation purposes, with no external application or generalization, usually do not constitute human subject research and usually do not require IRB review.
QA activities constitute human subject research and require IRB review, when they are designed or intended, at least in part, to develop or contribute to generalizable knowledge.
Is this Research? Exempt? Expedited?

5. HRPP 201
March 2009
Case Study #1
The Infection: Don’t Pass It On (IDPIO) campaign has contacted the Academy for Educations Development to conduct 20 patient focus groups and 20 staff/employee focus groups throughout the VA health care system. IDPIO hopes to learn more about why some choose to receive the flu vaccine and why others don’t, and whether the educational materials influence vaccination rates.
Is this Research? Exempt? Expedited?

6. HRPP 201
March 2009
Points to consider
No prospective intent to conduct research as part of the activity
Make clear to respondents that data are being collected for health care operations purposes
Findings may not be presented as research
Analyses beyond that required for operations requires prior IRB review
Is this Research? Exempt? Expedited?

7. When is it program evaluation?
HRPP 201
March 2009
When is it program evaluation?
The intent is to implement a program and evaluate its effectiveness.
Can you publish it?
Is this Research? Exempt? Expedited?

8. HRPP 201
March 2009
Case Study #2
The Office of Nursing Services has initiated an RN Residency program. It will have an evaluation component and presentations and publications are anticipated.
Is this Research? Exempt? Expedited?

9. HRPP 201
March 2009
Points to consider
There is no prospective intent to conduct research as part of the activity
Make clear to participants that data are being collected for health care operations purposes
Findings may not be presented as research without IRB approval
Analyses beyond those needed for operations require IRB review
Is this Research? Exempt? Expedited?

10. How can IRB review be done after data have been collected?
HRPP 201
March 2009
How can IRB review be done after data have been collected?
IRB approval for the research use of previously collected identifiable data, or
Expedited verification from an IRB that the research use of non-identifiable data is exempt or does not involve human subjects
Can the IRB approve a manuscript?
Is this Research? Exempt? Expedited?

11. Is it “Exempt”? HRPP 201 March 2009
Is this Research? Exempt? Expedited?

12. HRPP 201
March 2009
Exempt
Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
[Exemptions b(1-6)] [45 CFR (b)]
Exemption categories 1-5 are not applicable to research governed by FDA regulations (21 CFR 50.20)
Is this Research? Exempt? Expedited?

13. Categories of Exempt Research
HRPP 201
March 2009
Categories of Exempt Research
Research conducted in established educational settings, involving normal educational practices
Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior
Same as # 2, but covers elected officials
Research involving use of existing data
Research and demonstration projects by approval of agency heads
Taste and food quality
Is this Research? Exempt? Expedited?

14. HRPP 201
March 2009
Exempt if it is “ONLY”…
Research in one or more exempt categories, for example, an anonymous survey of adults.
AND NOT research in any covered research category, for example, collecting private identifiable data from future records.
Is this Research? Exempt? Expedited?

15. Is It a “Covered Activity”?
HRPP 201
March 2009
Is It a “Covered Activity”?
Is this Research? Exempt? Expedited?

16. What are the Covered Research Categories?
HRPP 201
March 2009
What are the Covered Research Categories?
Identifiable private information?
Vulnerable populations?
Subjects vulnerable to coercion or undue influence?
Treatments or procedures?
Incomplete Information?
These types of activities would not qualify for exemption.
Is this Research? Exempt? Expedited?

17. HRPP 201
March 2009
Case #3:
The IRB chairperson receives a protocol requesting exemption from IRB review under 45 CFR (b) 4 (refer to chart 2 & 5). The protocol includes the use of adipose tissue being taken from patients during liposuction. The samples are being collected at another site, and the local investigator wants to obtain them for use in a study at the VA. When the VA investigator receives the samples they will be de-identified. The patients at the site collecting the samples were not consented for this use.
What should the Chair do?
Is this Research? Exempt? Expedited?

18. HRPP 201
March 2009
Points to consider…
Does this study use existing specimens? “Existing” means existing before the research is proposed to the IRB to determine whether the research is exempt.
Should the subjects be or have they been consented (from another study…use your data for future studies)?
Are they asking for a waiver of consent?
FDA may not recognize exemptions from a specimen collection that has not been authorized by an IRB.
Is this Research? Exempt? Expedited?

19. IRB determinations for exemptions
HRPP 201
March 2009
IRB determinations for exemptions
IRB Chair or an IRB member designated by the Chair (some sites may elect full committee review)
Exemption documented in the IRB records (including category)
Decision communicated in writing to investigator
R&D Committee reviews requests for exemption prior to initiation (VHA Handbook )
Subject to R&D Committee annual review (VHA Handbook )
Is this Research? Exempt? Expedited?

20. What research activities are eligible for expedited review?
HRPP 201
March 2009
What research activities are eligible for expedited review?
No more than Minimal Risk.
Must fit one or more of the categories on the Expedited Review Categories List [Authority: 45 CFR and 21 CFR ]
Minor changes in previously approved research during the period for which the approval is authorized
Is this Research? Exempt? Expedited?

21. HRPP 201
March 2009
Minimal risk
…means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests. (45 CFR (i))
Is this Research? Exempt? Expedited?

22. HRPP 201
March 2009
Expedited Categories
Clinical studies of drugs and medical devices only under specific conditions
Collection of blood samples
Biological specimens obtained by non-invasive means
Collection of data through non-invasive procedures
Materials collected solely for non-research purposes
Collection of data from voice, video, etc.
Research employing surveys, etc. (OMB Issue)
Continuing review under specific conditions
Is this Research? Exempt? Expedited?

23. HRPP 201
March 2009
Case #4:
This study proposes to collect data on 5,000 VA patients with ICU admissions from to compare statistical models of risk adjustment and mortality prediction. There is no direct patient contact and scrambled patient identifiers are used to link data from various sources (Austin, Pharmacy Benefits Management, CPRS).
Is this Research? Exempt? Expedited?

24. HRPP 201
March 2009
Case #5
An investigator proposes a medical record review of 200 charts. No identifiers will be recorded. The data will be collected during the upcoming year as new patients join the Endocrinology clinic. Does the study qualify for exemption under 45 CFR (b)(4)?
Is this Research? Exempt? Expedited?

25. Another Good Reference
HRPP 201
March 2009
Another Good Reference
Guidance on Research Involving Coded Private Information or Biological Specimens:
Is this Research? Exempt? Expedited?

26. HRPP 201
March 2009
IRB Determinations
IRB Chair or one or more experienced reviewers designated by the Chair from among members of the IRB
Notification of IRB members & PI
Minutes and/or protocol file must reflect eligibility category
Subject to continuing review based on IRB approval date
Requires R&D Approval (currently, there is no option for expedited/exempt review from the R&D Committee)
Is this Research? Exempt? Expedited?

27. HRPP 201
March 2009
QUESTIONS
Is this Research? Exempt? Expedited?