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Exempt Research Studies Involving Human Subjects
- Will my research qualify as exempt if some of my subjects are deceased?
- What are the DHHS exempt research categories?
- Does the FDA provide any exemptions to IRB review?
- Are there any exceptions concerning the populations that may be enrolled in exempt research?
- What are the other exceptions to the DHHS exempt categories?
- How does an investigator submit a study for JHM IRB Exemption?
- What is limited IRB review and what exempt categories require limited IRB review?
- Are there any new research activities that may now qualify for exemption under the revised common rule?
- Does Exempt Research have an expiration date?
The Department of Health and Human Services (DHHS) and FDA regulations apply to research involving human subjects, but there are some categories of research that the regulations consider to be exempt research. To qualify as an exempt study, the research must fall within one of the specific federal regulatory categories. A determination of exemption must be made by the JHM IRBs and principal investigators must submit all such studies for their review. Although the research may qualify as exempt, it must still be conducted in accordance with the ethical principles for human subjects research outlined in the Belmont Report.
The human subjects regulatory protections, and the requirement for JHM IRB review, do not apply to research in which ALL of the subjects are deceased. Research involving deceased populations is subject to compliance with HIPAA, however, and the investigator must submit HIPAA Form 5 to the JHM IRB to access or collect the protected health information of the decedents. Even if a single subject is living, all of the human subjects protections apply, and the investigator must submit an eIRB application with an accompanying HIPAA Form 5 to the JHM IRB.
2. What are the DHHS exempt research categories?
The DHHS exempt categories may be found here.
The Common Rule includes six exempt categories in 46.101(b). The Revised Common Rule includes eight categories in 46.104(d) (1-8). Johns Hopkins has made an Institutional decision that broad consent will not be permitted at this time. As a result, the JHM IRB will not consider applications under the new exempt categories 7 and 8, which require broad consent.
The FDA regulations detail only three types of exemption:
(1) Research which started before July 27, 1981, and either did not require FDA approval before that date, or, was subject to requirements for IRB review prior to that date, and remains subject to review by an IRB which meets FDA requirements;
(2) Emergency use of a test article, provided any such use is reported to the JHM IRB within 5 working days AND any future use of the test article at JHMI is subjected to JHM IRB review;
(3) The taste and food quality evaluation provided for above in category (6).
Any other research subject to FDA regulation cannot be exempt. Research is subject to FDA regulations if it involves a drug, medical device, food, or other product regulated by the FDA.
There are no restrictions on the inclusion of pregnant women, fetuses or neonates in exempt research.
DHHS regulations prohibit the conduct of research involving prisoners from qualifying as exempt research except for research aimed at involving a broader subject population that only incidentally includes prisoners.
Children may be included in exempt research with the following limitations:
a. Children may only be enrolled in research that qualifies for exempt category 2 [surveys, interviews, public observations] if the investigators do not participate in the activities being observed;
b. Children may not be enrolled in research qualifying for exempt category 3 [benign behavioral interventions].
Other regulatory requirements and the JHM institutional policy provide that even if a study falls within one the DHHS categories it must receive JHM IRB review (either expedited or convened) if it has one or more of the following characteristics:
(1) The research falls under the purview of FDA (drug, device, biologic or other covered products Research is subject to FDA if it involves a drug or medical device other than the use of an approved drug or medical device in the course of medical practice, or if the data will be submitted to or held for inspection by the FDA).
(2) The research involves foster children or wards of the state, including exempt submissions strictly for the purposes of accessing their protected health information.
New projects that may meet the federal and organizational criteria for exemption must be submitted through eIRB. The research may not start until a JHM IRB grants an acknowledgement of exemption in writing. The IRB exemption letter will state whether the exempt research requires further oversight to protect research participants.
After the eIRB application requesting exempt review is submitted, JHM IRB staff will send a written response to the Primary Investigator (PI) to indicate either:
a) the proposed research activity is exempt and may be conducted without ongoing IRB review; or
b) the project is not exempt and explain why.
If the project is not exempt, the response will note that submission of an eIRB application requesting expedited or convened review is required. Written confirmation of an exemption must be available for grant certifications.
Limited IRB review is a process that is required for projects qualifying for exempt category 2 (iii) and 3(C), and does not require consideration of all the approval criteria described in §46.111. In limited IRB review, the IRB must determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of subject data. Limited IRB review may be completed by a single IRB member via the expedited review mechanism.
DHHS exempt category #3 is intended for research studies that include “benign behavioral interventions” (to which adult participants must prospectively agree) combined with the collection of information via verbal or written responses including survey responses, data entry, or through audiovisual recording. A behavioral intervention may involve the performance of a cognitive or behavioral task or the manipulation of the participant’s environment. Interventions must be brief in duration, harmless, not physically invasive, not likely to pose a significant lasting adverse impact, and not offensive or embarrassing. Because medical interventions are not behavioral interventions, studies that plan to include medical tests or procedures would not be eligible for exemption under category #3.
Research that is determined to be exempt does not require continuing review by the JHM IRBs. However, for projects that qualify as exempt research where a limited IRB review was conducted, the IRB may determine that continuing review or an institutional progress report is required. If a progress report is required, the expiration date for the study will be set at the period required for the progress report [may be 1, 2 or 3 years from the date of approval]. For exempt research where a progress report is not required, the research will automatically be given a 3-year expiration date. Thirty (30) days prior to the expiration date, an eIRB email reminder notification will be sent to the PI. To extend the research the PI will be asked to complete a simple “Extend Approval” activity in eIRB. If the PI does not request an extension, the research will automatically terminate 30 days after the expiration date.