NPRM: Escape for Many, Scant Relief for Those Left Behind

While the NPRM might do much to reduce the number of projects requiring IRB review, it would do little to improve the quality of review for those projects for which it is still required. This is a retreat from the more ambitious plans of the 2011 advance notice of proposed rulemaking.

[This post will be cross-posted to the Petrie-Flom Center’s Bill of Health, which is conducting an online NPRM Symposium.]

Fewer reviews

A great many of the proposals in the NPRM would reduce IRB jurisdiction and workload. These include:

  • Exclusion of some types of studies, such as oral history.
  • Changes to exemption procedures, to encourage alternatives to the present system, in which many institutions regard an exemption determination as a “level of review.”
  • Allowing a single IRB to approve a multi-site study.
  • Elimination of continuing review for most expedited studies.

That’s all well and good. IRBs and IRB staffs are overworked, often spending much of their time completing paperwork for low-risk studies. Both researchers and reviewers deserve relief.

But what about those studies that still face full-board review?

Single IRB review, but no consistency

The NPRM offers no reforms to improve the quality of IRB decision-making, but it could make IRB arbitrariness harder to spot.

Right now, some of the best evidence that IRBs make arbitrary decisions comes when identical proposals are submitted to multiple IRBs. Occasionally this happens as part of a deliberate test, as when Laura Stark asked eighteen IRB chairs how they would handle a proposal to study hiring discrimination, and got “very different” answers.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.