Is this Research? Exempt? Expedited?

Presented by:

Marisue Cody, PhD Deputy Director, PRIDE

Objectives

• Evaluate if the activity is research

• Evaluate if a study meets exempt criteria

• Evaluate if a study meets expedited criteria

… a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to “generalizable” knowledge. (38 CFR 16.102d)

Widespread information…

Research

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.

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.

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

When is it program evaluation?

• The intent is to implement a program and evaluate its effectiveness.

• Can you publish it?

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.

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

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 it “Exempt”?

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 46.101(b)]

• Exemption categories 1-5 are not applicable to research governed by FDA regulations (21 CFR 50.20)

Categories of Exempt Research

1. Research conducted in established educational settings, involving normal educational practices

2. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior

3. Same as # 2, but covers elected officials

4. Research involving use of existing data

5. Research and demonstration projects by approval of agency heads

6. Taste and food quality

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 It a “Covered Activity”?

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.

Case #3:

The IRB chairperson receives a protocol requesting exemption from IRB review under 45 CFR 46.101(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?

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.

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 1200.5)

• Subject to R&D Committee annual review (VHA Handbook 1200.5)

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 46.110 and 21 CFR 56.110]

• Minor changes in previously approved research during the period for which the approval is authorized

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 46.102(i))

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

Case #4:

This study proposes to collect data on 5,000 VA patients with ICU admissions from 2003-2004 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).

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 16.101(b)(4)?

Another Good Reference

Guidance on Research Involving Coded Private Information or Biological Specimens:

http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf

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)