(Nov. 2015 Issue) Local Institutions Would Still Be Liable Even if Distant IRBs Review Their Studies

Vol. 30, No. 11, November, 2015

In This Issue

Local IRB Contexts and Federal Officials … p. 3

Reduced IRB Use of Continuing Reviews … p. 4

IRBs Would Change Expedited Reviews … p. 5

IRBs Would Change Biospecimen Reviews … p. 6

IRBs and Placebo-Controlled Experiments … p. 7

FDA: Researcher Skips IRB Review … p. 8

OHRP: Extensive IRB Files Needed … p. 9

In Court: Researcher Claims Government
Does Not Have Authority to Punish Him … p. 10

In Congress: Allegedly “Dangerous” Bill
Moves Closer to Passage in Senate … p. 11

In Agencies & Organizations … p. 12

Compliance Conferences & Courses … p. 14

Local Institutions Would Still Be Liable Even if Distant IRBs Review Their Studies … p. 3

We continue this month with coverage of the immensely important recent proposal to modify many of the existing regulations on the protection of human research subjects. The proposal came in the form of a Notice of Proposed Rulemaking (NPRM), following the release about four years ago of an Advance Notice of Proposed Rulemaking (ANPRM).

Normally, the next step in the regulatory process would be the release of a final notice containing whatever portions of the ANPRM and the NPRM that the Department of Health and Human Services (DHHS) decides to keep and which portions to drop. However, as we urged last month, we hope that affected entities such as Institutional Review Boards (IRBs), institutions, individual researchers, and others will do what they can to at least extend the deadline for comments to the NPRM (i.e., now set for December 7).

Federal Officials Not Worried About Local IRB Contexts … p. 4

As discussed in the preceding article, the requirement for multisite human studies to have only one lead IRB review all the sites’ protocols is a major component in the recent proposed changes to the current Common Rule. Despite fears expressed by some IRBs and institutions, federal officials apparently are not especially concerned about factors possibly unique to the locality of a research project. For example,

Relevant local contextual issues (e.g., investigator competence, site suitability) pertinent to most studies can be addressed through mechanisms other than local IRB review. For research where local perspectives might be distinctly important (e.g., in relation to certain kinds of vulnerable populations targeted for recruitment), local IRB review could be limited to such consideration(s); but again, IRB review is not the only mechanism for addressing such issues.

The evaluation of a study’s social value, scientific validity, and risks, and benefits, and the adequacy of the informed consent form and process generally do not require the unique perspective of a local IRB (80 Fed. Reg. 53933-54061 at p. 53984, September 8, emphasis added).

Proposal to Reduce IRBs’ Use of Continuing Reviews … p. 5

As we continue our coverage of the recent major proposal to revise human subject protection regulations, we turn to an area of Institutional Review Board (IRB) duties that has often been burdensome for many IRBs. That area is the ongoing need for continuing reviews by IRBs. This topic is addressed in the section of the proposal titled “F. Changes To Promote Effectiveness and Efficiency in IRB Operations.”

1. Continuing Review of Research (NPRM at ç___.109(f); Current Rule at ç___.109(e))

a. NPRM Goal

The goal is to reduce or eliminate the need for continuing review in specific circumstances, thereby reducing regulatory burden that does not meaningfully enhance protection of subjects (80 Fed. Reg. 53933-54061 at p. 53984, emphasis added).

This paragraph is followed by a repeat of the existing regulations, with which we will assume readers are already familiar.