(Jan. 2016 Issue) IRBs and Record Keeping for Review Exemption Decisions

Vol. 31, No. 1, January, 2016

In This Issue

IRBs, Record Keeping, and Exemptions … p.3

IRBs and Expansion of IRB Duties … p.4

IRBs Need Not Review These Activities … p.5

IRBs and Specified Low-Risk Research … p.6

IRBs and Eligibility of Study Exclusions … p.7

IRB Membership Regulations to Change … p.8

FDA: Researcher Ignores Study Subject

Inclusion Criteria in His Own Protocol … p.9

OHRP: Failure to Get IRB Approval … p.10

In Court: Researcher Found Guilty of
Misconduct Blames Team Members … p.11

In Agencies & Organizations … p.12

Compliance Conferences & Courses … p.14

IRBs and Record Keeping for Review Exemption Decisions … p.3

The preceding article on exemption from IRB review notes that IRBs must make and retain a record of how such an exemption decision is made. The massive Notice of Proposed Rulemaking (NPRM) also proposes to revise the current regulations on said IRB record keeping. Part of those changes are contained in a new version of ç___.104(c) and explained in the following section of the NPRM titled “b. Exemptions Subject to the Documentation Requirements of ç___.104(c) and No Other Section of the Proposed Rule.”

Four exemptions are proposed that will not be subject to any additional requirements apart from the need to keep a record of the determination that the study was exempt. Three of these four exemptions in proposed ç___.104(d) are versions of exemptions found in the current rule.

A revised version of exemption category 1 in the current Common Rule (research conducted in established or commonly accepted educational settings) is found at proposed ç___.104(d)(1) in the NPRM.

A revised version of the current exemption category 5 (research and demonstration projects) is found at proposed ç___.104(d)(2). Exemption category 6 in the current Common Rule (taste and food quality evaluations) is found in the NPRM at ç___.104(d)(4), and is unchanged” (80 Fed. Reg. 53933-54061 at p. 53957, September 8, emphases added).


Concern Over Unrealistic Expansion of IRB Duties … p.4

The preceding HRR article discusses various proposed categories of activities that are or will be exempt from the requirements of IRB review. The federal Notice of Proposed Rulemaking NPRM) issued in September of 2015 also discusses special privacy requirements that apply to two of the proposed IRB review exemption categories.

These new privacy safeguards are described in the regulations at ç___.105. Ironically, although these new requirements are designed to ease IRB burdens, the NPRM’s preamble states that the new provisions may actually increase IRB burdens. Thus, it addresses that possibility in the relevant “Questions for Public Comment” section of the NPRM, which we present at the end of this article.

“Two exemption categories are proposed which will be subject to the documentation requirement and the new privacy safeguards. The first exemption category is for certain research involving educational tests, surveys, interviews, or observation of public behavior. The second category is for secondary research use of identifiable private information originally collected for non-research purposes where notice was given” (see 80 Fed. Reg. 53933-54061 at page 53961, September 8, 2015, emphasis added).


IRBs Would Not Have to Review These Activities … p. 5

The next topic in the September 8, 2015, NPRM is the list of explicit exclusions for multiple activities that Health and Human Services (HHS) is proposing to not be covered. There are three overall categories of activities to be excluded from being covered by the Common Rule, with a total of eleven subcategories. The three overall categories are:

“(a) Exclusion of Activities that are Deemed Not Research (NPRM at ç___.101(b)(1)) [six subcategories, see 80 Fed. Reg. 53947, column 2, for preamble explanation] ….

(b) Exclusion of Activities That Are Low-Risk and Already Subject to Independent Controls (NPRM at ç___.101(b)(2)) [four subcategories, see 80 Fed. Reg. 53950, column 2, for preamble

explanation] …. [and]

(c) Applicability of Exclusions to the Subparts [NPRM sections on current Subparts B (for pregnant women, fetuses, and neonates); C (for prisoners); and D (for children)]” (op. cit., preceding HRR articles).