45 CFR 46.101 Is Still Dead

At the September AAAS meeting, I learned of the June 2008 report, "Expedited Review of Social and Behavioral Research Activities," put out by the Social and Behavioral Research Working Group, Human Subjects Research Subcommittee, Committee on Science, National Science and Technology Council. The brief report (11 pages, including a great deal of white space) offers thirteen "brief illustrative examples" of "social and behavioral research activities [that] qualify for expedited review . . . assuming that they also meet the standard of minimal risk."

While presenting itself as an effort to help researchers, administrators, and reviewers "avoid needless misunderstanding and delays in the review process," the document threatens to add misunderstandings and delays by suggesting review for many projects that should be exempted from IRB oversight.

Here are the thirteen examples, to which I have added numbers for discussion purposes. The categories listed at the end indicate the reasons the working group believes the examples are eligible for expedited review, based on the 1998 list of categories.

1. An analysis of student educational records to explore the relationship between student mobility from district to district and student academic achievement for students from various economic and ethnic backgrounds. [Category (5)];

2. A study of prison administration records to explore the relationship between inmates’ individual background characteristics, type of criminal violation, and acquisition of a Graduation Equivalent Development (GED) credential10. [Category (5)];

3. A study of medical records and survey data to compare people’s weight with the cultural attitudes of different subpopulations toward diet and exercise. [Category 5].

4. A study using video recordings to examine communication styles used by cooperating employees in a variety of business organizations. [Category (6)];

5. A laboratory study comparing patterns of eye movement and reading comprehension performance among novice and competent readers. [Categories (6) and (7)];

6. A study in experimental economics in which people play an economic game that involves offering and/or accepting amounts of cash provided as part of the experiment. [Category (7)];

7. A study of adults’ ability to identify accurately the perpetrators of staged thefts. [Category (7)];

8. A study attempting to validate a previously tested measure of extroversion/introversion with members of a previously untested cultural group. [Category (7)].

9. A research study using telephone surveys of persons who provide their names and information about their background characteristics, political beliefs, and voting behavior. [Category (7)];

10. An online internet study in which undergraduate students view a video clip about economic theory and then respond to computer-simulated scenarios about individual spending decisions. [Category (7)];

11. An ethnographic field study using un-structured interviews to explore the interrelationship between family life and involvement in religious activities. [Category (7)];

12. An ethnographic study using participant-observation where the researcher participates in the subject’s activities of daily life, such as an anthropologist studying an agrarian market place by sitting in the respondent’s market stall, observing interactions and sometimes selling items to help out. [Category (7)];

13. A participatory action research project in which middle school teachers and students use group discussions, surveys, and interviews to evaluate the school’s social studies curriculum and develop recommendations for improvements. [Category (7)];

Examples 1-3 are pretty clearly within IRB purview under existing regulations. The Common Rule covers research using "information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)." Unless such information has been stripped of identifiers or is already publicly available, a researcher needs approval to use it.

Examples 6 and 10, the economics experiments, are systematic investigations designed to develop or contribute to generalizable knowledge, not covered by any specific exemption. Though the experiments do not seem risky, the regulations cover such research.

By contrast, the remaining eight examples all should be exempt under 45 CFR 46.101.

Examples 4, 5, 7, 8, 9, 11, and 12 should be exempt under §46.101(b)(2) as

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

Example 13 should be exempt under §46.101(b)(1) as "Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods."

Though the report makes a few passing mentions of §46.101, it offers no explanation of why the examples given would not be exempt under that section. And presenting these exempt projects as eligible for review is bound to suggest that they are not, in fact, exempt. An IRB using this document as guidance may well insist on reviewing projects that should be none of its business.

I cannot say that I am shocked; the §46.101 exemptions have been meaningless since 1995, when OHRP decreed that researchers cannot be trusted to apply the exemptions themselves, and hinted that IRBs should be consulted. As Samuel Tilden put it at the July 2008 meeting of SACHRP,

In 1981, HHS amended its 1974 policy . . . including exemptions from the policy. In its explanation of the final regulations, HHS anticipated no [most] social, economic, and educational research would be exempted from coverage. I ask you, is that the case today?

It is not, and the only news in this report is the brazenness with which representatives of the signatory agencies disregarded the regulatory language they claim to uphold.

Note: This post was originally posted on 22 October 2008. It was edited on 26 November 2008 to include my analysis of example 10, which I erroneously left out of the original.

Note 2 [30 August 2010]. In reviewing this post, I realized that the official SACHRP transcript misquoted Dr. Tilden. I am rather sure he said "most social, economic, and educational research would be exempted from coverage," since this is the language in the Federal Register announcement of 26 January 1981. I have amended the quotation accordingly.