Human Research Report

Protecting Researchers and Research Subjects

Vol. 30, No. 11, November, 2015

In This Issue

Here’s an inside look at what you will receive in the newsletter, including actual excerpts.

V30 N11 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

Federal Officials Not Worried About Local
IRB Contexts … p. 3

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

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. 4

Use of Continuing Reviews 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 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)) …

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). This paragraph is followed by a repeat of the existing regulations, which we will skip.


IRBs Would See Change to Expedited Protocol
Reviews … p. 5

As we presented at the conclusion of the preceding article, the recent proposed changes to the Common Rule include changes in Institutional Review Board (IRB) reviews, such as for expedited IRB reviews. “Minimal risk” and expedited IRB reviews are inextricably linked. An approved list currently exists that describes the types of minimal risk studies that may be reviewed by IRBs using the expedited review procedure. The preamble to the proposed changes to the Common Rule examines this topic, noting that the expedited procedure can only be used if the IRB reviewer judges that the study involves no more than minimal risk.

In addition, OHRP [federal Office for Human Research Protections] has indicated that the activities on the current list should not be deemed to be of minimal risk simply because they are included on the list. Therefore, this proposed change [described in the preceding HRR article] represents a change in the default position, and now says that research included on the list only involves minimal risk, unless the IRB makes a determination that the research is actually greater than minimal risk.

Thus it is anticipated that more studies that involve no more than minimal risk would undergo expedited review, rather than full review, which would relieve a burden on IRBs (80 Fed. Reg. 53933-54061 at p. 53986, September 8, emphases added).