September 2005
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 state are considered exempt research. The research that falls into these special categories is subject to the institutional policies of the Johns Hopkins Medical Institutions (JHMI). To qualify as an exempt study, the research must fall within one of the specific regulatory categories AND satisfy the other regulatory and JHMI institutional requirements. The JHM IRB must determine that a project is exempt, not the principal investigator. Any study that the JHM IRB believes is not exempt must receive either expedited or convened review by the JHM IRB. If the study involves prisoners, it cannot be exempt under DHHS regulations. 1. Will my research qualify as exempt if some of my subjects are deceased? 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 HIPAA, however, and the investigator must submit HIPAA Form 5 to the JHM IRB. Even if just one of the subjects is living, all the human subjects protections apply, and the investigator must submit an exemption application and request and send a HIPAA Form 5 to the JHM IRB.
[top] 2. What are the DHHS exempt research categories? The DHHS exempt categories may be found on the JHM IRB Exempt Research Application Form and at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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. - (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.
[top] 3. Does the FDA provide any exemptions to IRB review? - 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. [top] 4. What are the other exceptions to the DHHS exempt categories? 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 JHMIRB 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 employees of the Johns Hopkins Health System or Johns Hopkins University School of Medicine or School of Nursing; 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.
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5. How does an investigator submit a study for JHM IRB Exemption? In September, 2005, 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. After the Exempt Research Application Form is submitted, JHM IRB staff will send a written response to the 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 a New Human Subject Research Application Form is required. Written confirmation of an exemption must be available for a grant application submitted with an exemption number in the human subjects section.
[top] ** Note: If you are receiving data from the National Heart Lung and Blood Institute (NHLBI), please refer to the following link http://www.nhlbi.nih.gov/resources/deca/irb.htm .The NHLBI has determined that this research will not qualify for an exemption.** |
