MSU HRPP Manual Section 8-1

8-1, Exemptions

“Unless otherwise required by department or agency heads, 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. . .” 45CFR 46.101(b)

“The following categories of clinical investigations are exempt from the requirements of this part for IRB review. . .” 21 CFR 56.104

Process
The investigator must submit an exempt application to the IRB, including sufficient supporting documents to make an exempt determination. This includes submission of an Exempt Appendix which will document why the PI feels the research proposal fits an exempt category of review. The exempt application is submitted through the MSU IRB online system. The PI must confirm through the PI assurance form that they have read and accepted the responsibility to protect research subjects if the research study is determined exempt.

IRB staff will review the application to determine if the activity meets the federal definition of research and/or clinical investigation with human subjects. See HRPP Manual 4-3 “Determination of Human Subject Research” for requirements.

If the project is human subject research, they will then determine if the defined project meets the exemption criteria specified below using an exempt determination worksheet. The staff may consult or refer the research study to the IRB chair or members who will make the determination of whether the research meets the exemption criteria. The IRB chair or member may also make the exempt determination when assigned to review expedited or full review research studies. The completed exempt determination worksheet is associated with the file and the research study will be processed based on the level of review.

If the research study is determined to meet the criteria for exempt status and if the PI assurance form for an exempt research study has been received, the IRB staff will notify the PI that the exempt determination letter is available.An exempt determination letter cannot be issued until the PI assurance form has been received by the IRB office.

If it is determined that the research study does not meet the criteria for exempt status, IRB staff will communicate this to the PI informing him/her of the determination. The communication will include an explanation of why the research study did not meet the exempt criteria. The IRB staff will assign the appropriate category to the application, request additional information as needed, and initiate the relevant IRB review process, e.g., assign the chair to review the application.

Processing of applications for exempt status is estimated to take 7-9 working days. Processing time may increase if the application is incomplete, unclear, or lacks all necessary supporting documents (e.g., signed PI assurance, consent process information, instruments, exempt appendix).The application is not considered submitted to the IRB until all necessary supporting documents are received. In addition, the time line can be extended due to unaddressed comments.

Individuals assigned to review an exempt application in which she or he has a conflict of interest cannot review the application. The policy and procedure (e.g., notification procedures) described in HRPP Manual 10-1 “Conflict of Interest” shall be followed.

Criteria for Exempt Status
The criteria for exempt status follow all applicable federal regulations including 45 CFR 46.101(b)(1) through (6), 45 CFR 46.301(a), 45 CFR 46.306(a) and (b), 45 CFR 46.401(b) and 21 CFR 56.104. The criteria are applied to all research regardless of funding or funding source, with limited exceptions outlined in HRPP Manual 8-8 “Flexibility Initiatives.”

These regulations identify specific categories of exempt research activities and also identify when there are exceptions. In order for a study to qualify for an exempt determination, all aspects of the study must be within one or more exempt categories.

To be classified as exempt, the research:

  1. Must involve only procedures or be a type of research study listed in one or more of the exempt categories (see exempt categories sections below);

  2. Cannot involve any of the exceptions for the exempt categories for research that involves children (see children section below);

  3. Cannot involve prisoners as research subjects; and

  4. Cannot be greater than minimal risk. “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” 45 CFR 46.102(i)

U.S. Food and Drug Administration (FDA) Exempt Categories
The following exempt categories apply to research subject to FDA regulations (i.e., clinical investigations). 21 CFR 56.104 sub-categories (a), (b), and (c) cannot be applied to activities that are regulated by the U.S. Department of Health and Human Services (DHHS).

21 CFR 56.104 Exemptions from IRB requirement. “The following categories of clinical investigations are exempt from the requirements of this part for IRB review:

“(a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.”

“(b) Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.”

“(c) Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.”

“(d) Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or 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.”

DHHS Exempt Categories
The following exempt categories apply to research subject to DHHS regulations. 45 CFR 46.101(b) subcategories (1), (2), (3), (4), and (5) cannot be applied to activities that are FDA-regulated.

45 CFR 46.101(b). “Unless otherwise required by Department or Agency heads, 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, 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.”

“The Office for Protection from Research Risks (OPRR) has determined that the following criteria (see 48 FR 9266-9270, March 4, 1983) must be satisfied to invoke the exemption for research and demonstration projects examining "public benefit or service programs" as specified under Department of Health and Human Services (HHS) regulations at 45 CFR 46.101(b)(5):

  • The program under study must deliver 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).

  • The research or demonstration project must be conducted pursuant to specific federal statutory authority.

  • There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB).

  • The project must not involve significant physical invasions or intrusions upon the privacy of participants.”

“(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.”

Exempt Category Flexibility Initiatives
When certain criteria are met (e.g. project does not include use of federal funds), a research project that would not otherwise qualify for exempt review through the DHHS or FDA exempt categories may be granted exempt status through HRPP flexibility initiatives. See HRPP Manual 8-8 “Flexibility Initiatives” for applicability and restrictions.

Research Involving Children
Research involving children cannotbe classified as exempt under category (2) if the research involves:

  • Survey

  • Interview procedures

  • Observations of public behavior when the investigator participates in the activities being observed

Research involving children can be classified as exempt category (2) if the research involves only educational tests and / or observation of public behavior where the investigator does not participate in the activities being observed and meets the other conditions of 45 CFR 46.101(b)(2).

Certain research with children that involves surveys, interviews, or observations may be eligible for exempt category 45 CFR 46.101(b)(1). The limitations on exemption 45 CFR 46.101(b)(2) applies to research that is not eligible for exemption 45 CFR 46.101(b)(1).

Criteria for Protection of Human Subjects in Exempt Research
Research that is determined to be exempt from IRB review is not exempt from protection of human subjects. The Belmont Report principles apply to exempt research. The following criteria to protect human subjects must be met and the principal investigator must assure and assume responsibility to:

  1. Ensure that researchers engaged in human subject research are trained in the ethical principles, relevant federal regulations, and institutional policies governing human subject research.

  2. Ensure that the subjects are informed of the research through a consent process when appropriate.

  3. Ensure that subjects are equitably selected.

  4. Ensure subject privacy and to maintain the confidentiality of information about the subject.Privacy refers to the right of an individual to control her/his personal information.Confidentiality applies to the obligation of someone who obtains such personal information to protect it.

  5. Ensure that researchers engaged in human subject research adhere to the appropriate policies to protect human subjects, maintain confidentiality and privacy, and adhere to accepted ethical standards.

  6. Report any complaints from subjects to the HRPP if the complaints may change the level of review from exempt to expedited or full review.

  7. Report any unanticipated problems involving risks to subjects or others to the HRPP. See HRPP Manual 9-1 “Unanticipated Problems Involving Risks to Subjects or Others” for procedures.

  8. Report to the HRPP any proposed change in the research study which may disqualify the research study from the exempt review level and which would require an expedited or full review level. If there is any question, the PI should consult the IRB staff. Failure to submit changes which disqualify a research study from the designated exempt category will be considered noncompliance and will be subject to investigation and action by the HRPP. See HRPP Manual 9-2 “Noncompliance” for procedures.

  9. Submit any proposed changes in the research study which may change the exempt category.

These criteria are specified in the PI assurance form for an exempt research study. The PI confirms that he/she understands and accepts these conditions.

Consideration of circumstances that may affect ethical principles should be taken into account when an exempt determination is made. For example, consideration such as whether the research involves student research pools, research on one’s own students, or course credit may affect equitable selection of subjects. Other considerations may include whether the research involves incomplete disclosure and/or deception or whether the research involves audiotaping or videotaping. Involvement of these circumstances in the research does not preclude an exempt determination. However, consideration should be made as to whether inclusion of such circumstances affects the exempt determination.

Changes to Exempt Research
In general, investigators are not required to submit changes to the IRB once a research study is designated as exemptas long as those changes do not affect the exempt category or criteria for exempt determination (changing from exempt status to expedited or full review, changing exempt category) or that may substantially change the focus of the research study such as a change in hypothesis or study design. If new external funding is obtained for an active human research project that had been determined exempt, a new exempt application will be required, with limited exceptions.

Changes in procedures that may change the exempt designation include but are not limited to:

  • New knowledge that increases the risk level

  • Use of any methods described in the expedited review categories that do not meet the exempt criteria in the designated category

  • For projects designated under DHHS exempt category (2):

    • Surveying or interviewing children or observing public behavior of children and participating in the activities being observed

    • Addition or change to an educational test, survey procedure, interview procedure, or observation of public behavior through which information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and 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

  • For projects designated under DHHS exempt category (4): Change in the way identifiers are recorded (directly or indirectly) from existing data, documents, records, pathological specimens, or diagnostic specimens so that subjects can be identified

  • Addition of prisoners as research subjects

  • Addition of other vulnerable populations that may pose more than minimal risk

  • Under certain circumstances, addition of a funding source

  • Addition of exempt category not previously approved by the IRB

  • Change that may substantially change the focus of the research study such as a change in hypothesis or study design.

If there are plans to make any of the above changes, the investigator must contact the IRB staff. A new initial application may have to be submitted to the IRB with all appropriate supporting documents (e.g., new or revised instruments, consent forms) for review and approval by the IRB prior to initiation of such changes. The application will then be reviewed in accordance with HRPP Manual 8-2 “Expedited Review Procedure” or 8-3 “Full Board Review.”

If investigators are unsure of whether a proposed modification changes the exempt status or category and needs to be submitted for review, they are encouraged to contact the IRB staff. Investigators should send an email with a description of the proposed change to the IRB.

Personnel Changes
After determination of the exempt status, the PI is responsible for maintaining records of personnel changes and appropriate training. The PI is not required to notify the IRB of personnel changes on exempt research. However, he or she may wish to submit personnel changes to the IRB for recordkeeping purposes (e.g. communication with the Graduate School) and may submit such requests by email. If there is a change in PI, the new PI must sign a PI Assurance form and the previous PI must submit the Supplemental Form to Change the Principal Investigator.

Closure
Because research determined to be exempt does not require continuing review, investigators are not required to notify the IRB when the research study is complete. However, the PI can choose to notify the IRB when the project is complete and is especially recommended when the PI leaves the university.

Site Visits of Exempt Research
The HRPP maintains the authority to perform site visits of research determined to be exempt (see HRPP Manual 8-10 “Research Site Visits” for policies and procedures) for up to three years after the study is completed. If the site visit reveals that the research activities differ from the application to the IRB for exempt status and/or no longer meet criteria for exempt status (e.g., conducting non-approved research that meets the criteria for expedited or full review status) or if investigators are not fulfilling the agreed upon assurances for subject protection, the research may be considered in noncompliance. See HRPP Manual 9-2 “Noncompliance” for policies and procedures. Investigators should retain research records for site visit purposes following MSU guidelines, “Michigan State University Guidelines on Research Data: Management, Control and Access” (rio.msu.edu/research-data).

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 11-2-2005. Revision 2 approved by VP Research & Graduate Studies on 3-9-2008. Revision 3 approved by VP Research & Graduate Studies on 5-6-2008. Revision 4 approved by VP Research & Graduate Studies on 9-3-2009. Revision 5 approved by VP Research & Graduate Studies on 7-22-2011. Revision 6 approved by VP Research & Graduate Studies on 12-11-2015.

Related HRPP Manual Sections

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