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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?
- What are the other exceptions to the DHHS exempt categories?
- How does an investigator submit a study for JHM IRB Exemption?
- Does Exempt Research have an expiration date?
- Are you receiving data from the National Heart Lung and Blood Institute?
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 AND satisfy the other regulatory and JHMI institutional requirements. A determination of exemption must be made by the JHM IRBs and principal investigators must submit all such studies for their review. Note that DHHS regulations prohibit the conduct of research involving prisoners from receiving exempt review.
Although the research may qualify as exempt, it must still be conducted in accordance with the institutional ethical standards, including:
- The research is minimal risk.
- Selection of participants is equitable.
- If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data.
- If there are interactions with participants, the IRB will determine whether there should be a consent process that will disclose such information as:
- That the activity involves research.
- A description of the procedures.
- That participation is voluntary.
- Name and contact information for the researcher.
- There are adequate provisions to maintain the privacy interests of participants.
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. 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.
The DHHS exempt categories may be found on the JHM IRB Exempt Research Application Form and at http://www.hhs.gov/ohrp/humansubjects which provides:
(b) Unless otherwise required by Department or Agency heads [Please note: this reference is to government department or agency heads, not to JHM department directors], research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
(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.
(5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads [this reference is to government department or agency heads], and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of payment for benefits or services under those programs.
(v) The program under study delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).
(vi) The research is conducted pursuant to specific federal statutory authority.
(vii) There is no statutory requirement that an IRB review the research.
(viii) The research does not involve significant physical invasions or intrusions upon the privacy of subjects.
(6) Taste and food quality evaluation and consumer acceptance studies,
(i) if wholesome foods without additives are consumed or
(ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
The FDA provides 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 regulation if it involves a drug, medical device, food, or other product regulated by the FDA.
Other regulatory requirements and the JHMI institutional policy provide that even if a study falls within one of the six categories above (except category 5), it must receive JHM IRB review (either expedited or convened) if it has one or more of the following characteristics:
(1) The research involves interaction or intervention (excluding chart and record reviews -category 4) with hospitalized patients, institutionalized patients, outpatient clinic patients; or
(2) 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).
(3) The research involves category 2 and children as subjects, except for educational tests and projects involving the observation of public behavior and the investigators do not participate in the activities being observed.
(4) The research involves foster children or wards of the state, including exempt submissions strictly for the purposes of accessing their protected health information.
5. How does an investigator submit a study for JHM IRB Exemption?
New projects that may meet the federal and organizational criteria for exemption must be submitted through eIRB. The Exempt Wizard is available to help determine whether an investigator's project meets those criteria. The research may not start until a JHM IRB grants an 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 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.
Research that is determined to be exempt does not require continuing review by the JHM IRBs; however, in the interests of keeping the IRB files current, exempt 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.
If you are receiving data from the National Heart Lung and Blood Institute (NHLBI). The NHLBI has determined that this research will not qualify for an exemption. The PI will be required to submit an eIRB application requesting expedited or convened review.