HRPP Manual Section 8-1

Exemptions

Revised Common Rule (2018 Requirements)
“Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy . . .” 45 CFR 46.104(d)(2018 Requirements)
 
Pre-2018 Common Rule Requirements
“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)(Pre-2018 Requirements)
 
U.S. Food and Drug Administration Requirements
“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 application to the IRB office, including sufficient supporting documents to make an exempt determination. The application is submitted through the MSU IRB online system. The PI or PI proxy must confirm through the submission process that they will conduct the study in accordance with the responsibilities of researchers. If the PI proxy submits the study, the PI must confirm that they will conduct the study in accordance with the responsibilities of the researchers.  See HRPP Manual 4-6 “Responsibilities of Researchers.” For studies that require limited IRB review to meet the exemption criteria, the PI will also be asked to provide a limited IRB review assurance.

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 individual who makes the exempt determination completes the exempt determination worksheet. If the exempt determination is made by the convened IRB, documentation that the exempt criteria have been met and the research study specific information justifying why the criterion have been met shall be recorded in the minutes of the convened IRB meeting. The standard exempt determination worksheet form shall be used for documentation. A study that may otherwise qualify for exemption may require review by the IRB through the expedited or full board review procedures.

For studies that may be eligible for exemption if a limited IRB determination is made, the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB will also be assigned to make the limited IRB review determination. For exemption categories (2)(iii) and (3)(iii), the IRB must make the determination that the criteria in 45 CFR 46.111(7) have been met. In making the determination, HRPP Manual Section 6-6 “Privacy, Confidentiality, and Anonymity” is applicable. The expedited review procedure may be used to perform the limited IRB review. See HRPP Manual 8-2 “Expedited Review.” A standard form will be used to document the limited IRB review determination.

Ancillary reviewers are assigned to studies that may require additional MSU or other institutional reviews (e.g., hospital partners, biosafety review, raffle or drawings, department or college), that may utilize MSU resources, or that may be subject to additional federal requirements (e.g., Compliance office for Health Insurance Portability and Accountability Act (HIPAA) or Family Educational Rights and Privacy Act (FERPA)). The ancillary reviewer(s) is assigned to the study by the IRB coordinator. Depending on the ancillary review type and need, a response may be needed from the ancillary reviewer before an exempt determination letter can be released.

If the research study is determined to meet the criteria for exempt status, the PI will be notified that the exempt determination letter is available. 

If it is determined that the research study does not meet the criteria for exempt status, IRB staff will consult with the IRB chair and communicate this to the PI informing them 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 and study materials as needed, and initiate the relevant IRB review process, e.g., assign the chair to review the application or re-assign to another reviewer.

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., consent process information, instruments).  The application is not considered submitted to the IRB office until all necessary supporting documents are received. In addition, the timeline can be extended due to unaddressed comments or review by the convened IRB.

Individuals assigned to review an exempt application in which they have 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)(Pre-2018 Requirements), 45 CFR 46.104(2018 Requirements), 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 Initiative.”

These regulations identify specific categories of exempt research activities and identify when there are exceptions. 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 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)(Pre-2018 Requirements), 45 CFR 46.102(j)(2018 Requirements), 21 CFR 50.3(k)(FDA).
  4. For studies subject to pre-2018 Common Rule requirements, the study cannot involve prisoners as research subjects.
  5. For studies subject to the Revised Common Rule (2018 Requirements), the study cannot involve prisoners unless the research is aimed at involving a broader subject population that only incidentally includes prisoners.
  6. For exempt categories that require limited IRB review, the IRB must conduct a limited IRB review to make the determination required by the exemption.
  7. Cannot involve interactions that, based on a determination by the IRB, are:
    1. Likely to have a significant adverse lasting impact on the subjects or
    2. Likely that a reasonable person would find the interactions offensive.

Currently, MSU does not plan to use the Revised Common Rule (2018 Requirements) Exempt Category 7 or 8. MSU is no longer applying the limited IRB determinations under 45 CFR 46.104(d)(2)(iii) or 45 CFR 46.104(d)(3)(i)(C) to new study submissions.

Revised Common Rule (2018 Requirements) Exempt Categories

The following exempt categories apply to research subject to the Revised Common Rule (2018 Requirements). 45 CFR 46.104(d) subcategories  cannot be applied to activities that are FDA-regulated.

“Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

(1) Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

(2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

(3)

(i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(B) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

(4) Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;

(iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

(5) Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including 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. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

(ii) [Reserved]

(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.

(7) Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).

(8) Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);

(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;

(iii) An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.” 45 CFR 46.104(d)(2018 Requirements)

Limited IRB Review Criteria for Exempt 2(iii) and 3(iii)

“When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.” 45 CFR 46.111(a)(7)(2018 Requirements)

Pre-Common Rule Exempt Categories

The following exempt categories apply to research subject to pre-2018 Common Rule regulations. 45 CFR 46.101(b) subcategories (1), (2), (3), (4), and (5) cannot be applied to activities that are FDA-regulated.

“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.” 45 CFR 46.101(b)(Pre-2018 Requirements)

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 Common Rule.

“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.” 21 CFR 56.104

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 Common Rule (Pre-2018 or 2018 Requirements) or FDA exempt categories may be granted exempt status through HRPP flexibility initiatives. See HRPP Manual 8-8 “Flexibility Initiative” for applicability and restrictions.

Research Involving Children

Research involving children cannot be classified as exempt under category (2)(Pre-2018 Requirements) or category (2)(i) or 2(ii)(2018 Requirements) 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)(Pre-2018 Requirements) or category (2)(i) or (2)(ii)(2018 Requirements) 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)(Pre-2018 Requirements) or 45 CFR 46.104(d)(2)(i)(2018 Requirements) or 45 CFR 46.104(d)(2)(ii)(2018 Requirements).

For research subject to the Revised Common Rule (2018 Requirements), research involving children cannot be classified as exempt under category (2)(iii) or category (3).

Certain research with children that involves surveys, interviews, or observations may be eligible for exempt category 45 CFR 46.101(b)(1)(Pre-2018 Requirements) or 45 CFR 46.101(d)(1)(2018 Requirements). The limitations on exemption 45 CFR 46.101(b)(2)(Pre-2018 Requirements) or 45 CFR 46.104(d)(2)(2018 Requirements) applies to research that is not eligible for exemption 45 CFR 46.101(b)(1)(Pre-2018 Requirements) or 45 CFR 46.104(d)(1)(2018 Requirements). 

When research involves children, parent or guardian permission is typically required. For research conducted in schools, the research team must comply with the requirements of the local school district regarding parent or guardian permission. If affirmative parent or guardian permission is not required by the local school district, parent, or guardian notification with the ability to opt the child out of the research activity is typically required When the study is subject to FERPA or the Protection of Pupil Rights Amendment, additional requirements, including requirements related to parental permission may apply. See HRPP Manual Sections 2-2-D-i, Family Educational Rights and Privacy Act and 2-2-D-ii, Protection of Pupil Rights Amendment for requirements.

Interactions Likely to have Significant Adverse Lasting Impact on Subjects or Likely that a Reasonable Person Would Find Interactions Offensive

Although a study may be eligible for exemption, if a study may be likely to have a significant adverse lasting impact on subjects or may be likely that a reasonable person would find the interactions offensive, the study will be reviewed by the IRB to determine if the study meets these criteria.

The Principal Investigator’s department chair or the administrative unit head will be notified and asked to sign off on the study. The department chair or the administrative unit head may identify a faculty designee to perform this sign off. The department chair/administrative unit head or designee through the sign off provides acceptance for the study to proceed. If accepted, the process for convened IRB review will proceed. If the study is not accepted, convened  IRB review will not typically proceed until the department chair/administrative unit head or designee accepts the study. This review is intended to indicate support from the department for the research to proceed and an opportunity for the department to engage with the research team to address any institutional issues that may arise with the study. Comments directed to the research team by the department chair/administrative unit head or designee in the MSU IRB online system will be provided to the research team indicating that they are from the department chair/administrative unit head or designee. The IRB review may occur in parallel, but a final determination will not be issued until departmental/administrative unit acceptance is received.

If the IRB determines that the study is likely to have a significant adverse lasting impact on subjects or is likely that a reasonable person would find the interactions offensive, the IRB will determine the risk level of the study and whether the study can be reviewed under an expedited review procedure or by the convened IRB. The study will be reviewed in accordance with HRPP Manual 8-2 “Expedited Review Procedure” or 8-3 “Full Board Review.”

If the IRB determines that the study is not likely to have a significant adverse lasting impact on subjects or is not likely that a reasonable person would find the interactions offensive and the study qualifies for an exemption(s), the convened IRB or an IRB member will make the exempt determination. The IRB may also determine that the study should be reviewed under an expedited review procedure or by the convened IRB. The study will be reviewed in accordance with HRPP Manual 8-2 “Expedited Review Procedure” or 8-3 “Full Board Review.”

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 assumes 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 their 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, level of review, or change in study oversight (e.g., the use of student records, medical records, funding source).
  10. For studies where the exempt category requires limited IRB review under the Revised Common Rule (2018 Requirements):
    1. Report any proposed changes in the research study that may impact the limited IRB review criteria.
    2. For Exemption Category (2)(iii) and 3(iii), any proposed change to the provisions to protect the privacy of subjects and to maintain the confidentiality of data or that may impact those provisions must be submitted as a Modification for IRB review and approval before initiation of the changes.
    3. Submit a study closure.

These criteria are specified in HRPP Manual 4-6, Responsibilities of Researchers. The PI confirms that they will take responsibility for the study and accepts these conditions when submitting the application. For studies that are determined exempt under an exempt category that requires limited IRB review, the PI will also be asked to provide a limited IRB review assurance.

Circumstances that may affect ethical principles should be considered 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.

Consent

The Belmont Report principles apply to exempt research and subjects need to be informed of the research through a consent process when appropriate. In addition, funding requirements and federal, state, local, and/or international laws and regulations may require that specific information be provided to subjects through an informed consent process (e.g., certificate of confidentiality, genomic data sharing, European Union Data Protection Regulation, mandatory reporting requirements). If additional consent requirements apply to the study, the consent document(s) needs to include the required information when obtaining consent from subjects.  

Changes to Limited IRB Review Exempt Research

When a study is determined exempt under a category that involves limited IRB review under the Revised Common Rule (2018 Requirements), certain changes must be submitted as Modifications for IRB review and approval before initiation of those changes.

For Exemption Category (2)(iii) and 3(iii), any proposed change to the provisions to protect the privacy of subjects and to maintain the confidentiality of data, or that may impact those provisions, must be submitted as a Modification for IRB review and approval before initiation of the changes.

Changes in procedures that may impact the privacy of subjects or confidentiality of data include but are not limited to:

  • Change in how or where data is stored (e.g., server, cloud)
  • Change in how the data is coded, or who has access to the code
  • Change in format of how the data is collected (e.g., paper mail in survey to online survey)
  • Change in type of online survey software
  • Change in location of where the research is conducted (e.g., private location, public setting)
  • Change to risk type (criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation) that may alter privacy and/or confidentiality considerations
  • Change to subject population that may alter privacy and/or confidentiality considerations
  • Change to add audio or video recording
  • Other changes that may impact privacy of subjects or confidentiality of data

If there are plans to make any of the above changes, the investigator must submit a Modification application to the IRB with all appropriate supporting documents for review and approval by the IRB prior to initiation of such changes. The application will then be reviewed by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. The IRB member must confirm that that the criteria for the exemption and the limited IRB review continue to be met. A standard form will be used to document the review.

If investigators are unsure of whether a proposed modification needs to be submitted for review, they are encouraged to contact the IRB staff. Investigators should send a comment on the study through the MSU IRB online system with a description of the proposed change.

Changes to All Exempt Research

With the exception of studies determined exempt under a category that requires limited IRB review as described above, in general, investigators are not required to submit changes to the IRB office once a research study is designated as exempt as 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.

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

  • New knowledge that increases the risk level to more than minimal risk
  • 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 Revised Common Rule exempt category (1)(2018 Requirements):
    • Change in which the research would likely adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction.
  • For projects designated under Pre-2018 Common Rule exempt category (2) or Revised Common Rule exempt category (2)(i) or (2)(ii)(2018 Requirements):
    • 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 (or educational advancement for Revised Common Rule studies)
  • For projects designated under Revised Common Rule exempt category (3)(i) or (3)(ii) (2018 Requirements):
    • Change in 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, educational advancement, or reputation
    • Change in the type or length of intervention
  • For projects designated under Pre-2018 Common Rule 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
  • For projects designated under Revised Common Rule exempt category 4(ii): Change in the way identifiers are recorded (directly or indirectly)  
  • Addition of prisoners as research subjects for studies subject to the Pre-2018 Common Rule Requirements, or research aimed at prisoners for studies subject to the Revised Common Rule (2018 Requirements).
  • Addition of other vulnerable populations that may pose more than minimal risk
  • Addition or modification to interactions that are likely to have a significant adverse lasting impact on the subjects or are likely that a reasonable person would find the interactions offensive
  • Under certain circumstances, addition of a funding source if the source changes the scope of the study
  • Addition of a new regulatory requirement if the change alters the study scope, e.g., FERPA, HIPAA.
  • 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. If the change alters the study so that it no longer qualifies for exemption, the study will require review through the expedited or committee review procedure for IRB approval. The existing study submission in the MSU IRB online system may be used to submit required materials to conduct an  initial expedited or committee review. The PI must update the study through a modification / continuing review submission and upload all appropriate templates and 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 8-5, Initial Review and HRPP Manual 8-2 “Expedited Review Procedure” or 8-3 “Full Board Review.”

While the following changes may not alter the exempt determination, the administrative changes specified below must also be submitted as a Modification to the HRPP:

  • Change in Principal Investigator
  • Addition of a new regulatory requirement without changing study scope. Examples include FERPA, HIPAA, clinicaltrials.gov registration and results reporting, and data protection laws.
  • Addition of new funding if the source does not change the scope of the study

If a study has an associated funding source that is listed as pending, PIs are also asked to submit a Modification to update the status of funding from pending to funded.

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 a comment on the study through the MSU IRB online system with a description of the proposed change.

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 office of personnel changes on exempt research. However, they may wish to submit personnel changes to the IRB office for recordkeeping purposes (e.g., communication with the Graduate School) and may submit such requests through a Comment in the MSU IRB online system. If there is a change in PI, a Modification application in the MSU online system should be submitted, including the Supplemental Form to Change the Principal Investigator.

Closure

When a study is determined exempt under a category that requires limited IRB review under the Revised Common Rule (2018 Requirements), a study closure must be submitted to the MSU IRB. See HRPP Manual 8-9 “Closure” to determine when a study can be closed.

For exemptions that do not require a limited IRB review, investigators are not required to notify the IRB office when the research study is complete. However, the PI can choose to notify the IRB office 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 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.”

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. Revision 7 approved by Assistant VP Regulatory Affairs on 6-27-2018. Revision 8 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 9 approved by Assistant VP Regulatory Affairs on 11-21-2019.  Revision 10 approved by Assistant VP Regulatory Affairs on 11-29-2021.

Related HRPP Manual Sections