What is Exempt?
At the beginning of in the federal regulations, there is a list of categories of research that are exempt from the regulations. These include (but are not limited to):
- 1. 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.
- 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.
- 3. 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; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
As the reader will note, much of the research that is conducted by social scientists falls into these exempt categories. If much of our work is exempt from the regulations, why is there so much discussion around IRB issues and social science research?
What does Exempt Mean, in Practice?
In common parlance, exempt means not applicable. But in the federal regulatory system, there is a nuance: the determination that a project is exempt cannot be done by the investigator. It must be done by people designated by each institution who are well-acquainted with interpretation of the regulations and the exemptions (per OHRP guidance document 95-02). In practice, those people are IRB administrators or IRB members. Thus, even exempt projects come into contact with the institution's IRB apparatus.
In our opinion, it is this requirement that often leads from the required process of brief review, on to requests for more information, then on to exhaustive review, and finally to the application of all of the elements outlined in the regulations, just to be safe (see J. Michael Oakes on a credible threat). These extra steps are taken even though the OHRP has made it clear in public presentations that exempt means exempt. Furthermore, the OHRP has been willing to reiterate this via email.
As our email respondent notes and as we have emphasized elsewhere on this site - being free from regulatory requirements does not exempt us from conducting our work according to the highest ethical standards, and in a fashion consistent with the principles articulated in the Belmont Report. Our Professional Codes of Ethics provide us with guidance on these matters. .