Exempt or nonexempt? IRB must make the call
Flowchart and forms expedite decision process
Certain broad categories of research are exempt from full review of an institutional review board. Though federal regulations regarding exemptions are spelled out for investigators and IRBs alike, IRBs still are responsible for reviewing proposed protocols and approving exemptions.
"For initial review, the Federal Register list of categories is used as guidance. These categories are adhered to for all studies, regardless of whether they fall under the jurisdiction of DHHS [Depart-ment of Health and Human Services] or FDA [Food and Drug Administration]," says Paul Goebel Jr., vice president of Chesapeake Research Review in Columbia, MD, and an IRB Advisor editorial board member.
Before the IRB evaluates the protocol in light of the exemption categories, it must determine whether the research involves more than minimal risk and identify proposed participants, ensuring that prisoners, fetuses, pregnant women, or human in vitro fertilization will not be involved.
"The IRB should have a form which outlines each of the exemption provision in the regulations. The investigator then indicates which provision he or she believes is met by the project," says Goebel. "This accomplishes two things — one, the investigator is educated about the requirements for exemption; and two, the IRB is not performing the initial search for an exemption category."
The categories include:
- Educational setting — research conducted in established or commonly accepted educational settings, involving normal education practices, such as research on instructional strategies or the effectiveness of instructional techniques, curricula, or classroom management methods.
- Educational tests — research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior. If, however, the protocol includes provisions for collecting data that can be used to identify participants or if disclosure of participants’ responses could result in criminal or civil liability, damage the subjects financial standing, employability or reputation, the protocol would not qualify for exemption of full IRB review.
- Public officials — research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that do not meet the criteria discussed above but that include subjects who are elected or appointed public officials or candidates for public office unless the research is covered under federal statues that provide certain legal protections and requirements for confidentiality.
- Collection of data — 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. (See Exemption Decision Flowchart.)
- Public benefit — research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.
- Taste tests — taste and food quality evaluation and consumer acceptance studies are exempt if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient that is found to be safe by the FDA or approved by the Environmental Protection or the Food Safety and Inspection Service of the Food Safety and Inspection Services of the U.S. Department of Agriculture.
The University of Virginia (UVA) Human Investigation Committee (HIC) IRB in Charlotte-sville reviewed 460 protocols last year. Of those, the IRB averaged about 150 exempt protocols. "At any one time, we have around 300 active exempt protocols," reports Susie R. Hoffman, RN, BSN, CIP, director of the human investigation committee.
UVA asks investigators to complete a form that includes questions on the nature of the study, probability of harm, confidentiality of collected data, and how data will be used. (See UVA Exempt Application Form.) It also includes two sections that address HIPAA (Health Insurance Portability and Accountability Act) concerns, including questions on specific identifiers listed under parts 164.514(e) and 164.514(b) of the act, among them name, address, and telephone numbers; URLs (web addresses); medical record numbers; and vehicle identifiers and serial numbers, including license plate numbers.
"It is almost impossible for an investigator to know all the federal regulations regarding research, whether it is the criteria for exemption or anything else," Hoffman says. "We don’t expect them to be experts regarding the criteria, we just expect them to answer the questions on the Exempt Application Form and the HIC will determine if it meets the criteria for exemption."
Certain broad categories of research are exempt from full review of an institutional review board. Though federal regulations regarding exemptions are spelled out for investigators and IRBs alike, IRBs still are responsible for reviewing proposed protocols and approving exemptions.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content