Subject: IRB Review of Human Subjects Research – Exempt

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – that all human subjects research activities under its jurisdiction be reviewed to determine whether the research meets one or more of the exemption categories as defined by Federal regulations.

1. Exempt Eligibility

   The IRB may determine a research activity to be exempt where the only involvement of human subjects will be in one or more of the following categories:

   1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
      1. research on regular and special education instructional strategies, or
      2. 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:
      1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
      2. 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 (I)(B) of this policy, if:
      1. the human subjects are elected or appointed public officials or candidates for public office; or
      2. 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.
      1. public benefit or service programs;
      2. procedures for obtaining benefits or services under those programs
      3. possible changes in or alternatives to those programs or procedures; or
      4. possible changes I methods or levels of payment for benefits or services under those programs
   5. Taste and food quality evaluation and consumer acceptance studies,
      1. if wholesome foods without additives are consumed of
      2. 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. ^[1], ^[2]
   6. 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. ^[3], ^[4]
2. Only the IRB may determine which activities qualify for an exempt review. Investigators do not have the authority to make an independent determination that research involving human subjects is exempt and must contact the IRB concerning the status of proposed research or changes in ongoing research.
3. Modifications

   Certain changes may disqualify the research from exempt status. Therefore, any proposed changes to an exempt study must be submitted to the IRB for review and approval prior to implementation.

4. All research that has been determined to be exempt by the IRB may still be subject to other applicable Mayo Clinic institutional policies and procedures.
5. Exempt research activities are subject to the same subject protections and ethical standards as outlined in The Belmont Report . ^[5]
6. These exemptions do not apply to research involving prisoners. ^[6], ^[7]
7. Research Involving Children
   1. The exemptions specified above, in Section I. A, C, D, E and F all apply to research involving children.
   2. The exemption specified above in Section I.B. only applies for research involving observation of public behavior when the Investigator does not participate in the activities being observed. The exemption does not apply where the research involves survey or interview procedures or any direct interaction with the participants being observed. ^[8], ^[9]

^[1] 45 CFR 46.101(b)

^[2] 21 CFR 56.104(d)

^[3] 21 CFR 56.104(c)

^[4] IRB Policy X.C

^[5] Belmont Report

^[6] 45 CFR 46.101, footnote 1

^[7] IRB Policy VIII.B

^[8] 45 CFR 46.101, footnote 1; 45 CFR 46.401(b)

^[9] IRB Policy VIII.C