Bioethics Blogs

Political Scientists Complain about Lost Exemption

Political scientists and law professors are protesting the proposed elimination of the current exemption for research about public officials and candidates for office. The drafters may have eliminated the exemption by mistake, thinking that such research was exempted by other provisions of the proposed rule, which turns out not to be the case.

OHRP can’t explain why it cut the exemption

Since 1981, 45 CFR 46.101(b)(3)(i) has exempted “research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office.” I was never able to nail down the exact origin of this exemption, but my best guess is that it was a response to the criticism leveled by political scientist Ithiel de Sola Pool, one of the leaders of the 1978–1981 social science campaign against IRB regulation.

The 2011 ANPRM proposed that “The existing six exemption categories would be retained as part of the new Excused category.” (76 FR 44518). Since the ANPRM did not warn anyone that they might lose the public-official exemption, none of the 2011 ANPRM comments seems to have commented on its value.

The 2015 NPRM’s proposed rule, however, does not include the exemption. As the NPRM states, “The rationale for this change in the proposed NPRM is that it does not seem appropriate to single out this category of subjects for different treatment in this way.” (80 FR 53951) In other words, the drafters eliminated the exemption because they wanted to eliminate the exemption.

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.