Exempt Determination Review - Process and Checklist

Policy Number: 10
Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Effective Date: 10/8/2021

1. Policy

Exempt research projects present risks so benign to the human subjects who participate in them, that the federal regulations, (45 CFR 46.104), say such projects are exempt from full Institutional Review Board (IRB) review. However, these categories of research are not exempt from expedited review by The College of St. Scholastica IRB. The CSS IRB recognizes that the Federal Guidelines do not require IRB review of research that meets one or more of the exemption categories; however, we agree with the OHRP’s recommendation that the IRB, and not researchers, should be make the determination of exemption due to the potential for conflict of interest.

2. Purpose

The purpose of this document is to describe research activities involving human subjects that meet exemption criteria under 45 CFR 46.104. For example, survey procedures where no identifying information will be recorded that can link subjects to the data is exempt. Similarly, research that involves the use of existing data, documents, or specimens, where no identifying information will be recorded that can link subjects to the data is also exempt. If identifiers are collected, some studies are exempt if disclosure of the data could not reasonably place the subject at risk of civil or criminal liability or be damaging to the subject’s financial standing, employability, or reputation.

3. Procedure

In making exempt determinations, the IRB should have access to enough information to make a correct determination. The following materials must be submitted for initial review. Submission requirements are the same for reviews performed by the convened IRB and for reviews using expedited procedures.

• A completed IRB application that is submitted via IRBNet. The PI indicates his/her understanding of the PI's obligations by signing the PI Assurance section of the application. If the study is conducted by a student, the faculty advisor signs the PI Assurance section of the application.
• Informed consent document(s), if applicable.
• Recruitment materials, i.e., flyers, posters, web-pages, email messages, etc.
• Copies of all study measurements, e.g., questionnaires, surveys, or interview guides.
• Human subjects training verification. The IRB requires that the PI and all CSS affiliated research personnel complete human subjects training; training certificates are required to be renewed every three years.

Consequently, the following categories of exempt research are recognized by the College of St. Scholastica IRB:

Exemption at 1. Exemption (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.

Research conducted in educational settings, using normal educational practices that are unlikely to adversely impact either students’ opportunity to learn required content or the assessment of instructors who provide the instruction.

Exemption at 2. Exemption (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:

1. 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;
2. 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
3. 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 that there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data.

Research using educational tests, survey procedures, interview procedures or observation of public behavior, if at least one of the following is true:

1. The data are anonymous.
2. The data are non-sensitive.
3. The IRB conducts a limited review.

Exemption at 3. Exemption (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:

1. 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;
2. 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
3. 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 that there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data.

2. For the purpose of this provision, benign behavioral interventions are brief, 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.
3. If the research involves d eceiving 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. (See, SOP #14 Deception in Research w/ Sample Debriefing Scripts)

Research involving benign behavioral interventions (brief, painless, unlikely to have significant lasting adverse effects, and the subjects are unlikely to find the intervention offensive or embarrassing) with consenting adult subjects and at least one of the following is true:

1. The data are anonymous.
2. The data are non-sensitive. Sensitive data include, but are not limited to:
   • Sexual orientations, sexual harassment, sexual assault, sexual molestation or abuse, incest, practices of contraception, abortion, and/or pregnancy;
   • Substance use and/or abuse including, but not limited to, alcohol, marijuana, steroids, amphetamines, narcotics, any prescription medication legally or illegally obtained;
   • Questions regarding mental health (e.g. suicide, depression, obsessive-compulsive disorders, drug use, underage drinking, gambling, and/or eating disorders);
   • Traumatic experiences (e.g. being a victim of violence, child abuse, senior abuse, war or conflict experiences).
3. The IRB conducts a limited review.

Exemption at 4. Exemption (4) Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens if:

1. Identifiable private information or identifiable biospecimens are publicly available, OR
2. Information, which may include information about biospecimens, is recorded in unidentifiable manner and the investigator does not contact or re-identify the subjects, OR
3. Investigator’s use is regulated under HIPAA as “health care operations,” “research,” or “public health”, OR
4. Research is conducted by, or on behalf of, a Federal agency using information collected or generated by the government for non-research purposes, and the information is protected by federal privacy standards
   
   Secondary research (research using existing data, documents, records, pathological specimens, or diagnostic specimens) for which consent is not required, if at least one of the following is true:

1. The data are publicly available.
2. The data are anonymous, and the investigator does not contact or attempt to re-identify the subjects.
3. The research involves only the collection of health information when that use is regulated under 45 CFR 160 and 45 CFR 164 (The HIPAA Privacy Rule - The Rule requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization) and deemed “health care operations” or “research” or “public health activities and purposes.” MN law requires authorization (see SOP #... on waiver or alteration of consent).
4. The research is conducted by or on behalf of a federal entity using data collected for non-research purposes, if the data are maintained on technology in compliance with the E-Government Act of 2002, all data will be maintained on systems of record subject to the Privacy Act of 1974, and the data were collected subject to the Paperwork Reduction Act of 1995.

Exemption at 5. Exemption (5) Research and demonstration projects that are conducted or supported by a Federal department for public benefit and service programs research (e.g., through a grant of funding). This exemption is expanded to apply to such federally-supported research; no longer limited to federally-conducted research.

This exemption added requirement that Federal agency publish a list of projects covered by this exemption prior to commencing the research.

Research and demonstration projects which federal department or agency heads either conduct or approve, and are designed to study, evaluate, or improve public benefit or service programs.

Exemption at 6. Exemption (6) Taste and food quality evaluation and consumer acceptance studies:

1. If wholesome foods without additives are consumed, or
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.

Some taste and food quality evaluation and consumer acceptance studies. Note that for FDA-regulated research exemption (6) is an exemption from IRB review in 21 CFR §56, but unlike DHHS regulations is not an exemption from FDA requirements for consent in 21 CFR §50. If an organization’s policy is to grant exemptions to FDA-regulated research in category (6), then additional criteria for such exemptions would be that consent will be obtained in accordance with 21 CFR §50.20 and §50.25, and the consent will either be documented in writing in accordance with 21 CFR§50.27 or waived in accordance with 21 CFR §56.109(c)(1).

New Exemption at 7. (Not adopted by the CSS IRB) Covers storage or maintenance for secondary research for which broad consent is required and limited IRB review. Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review.

 NEW Exemption at 8. (Not adopted by the CSS IRB) Covers Secondary research for which broad consent is required. Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if specific criteria are met.

Note: CSS will not adopt the option for broad consent provided in Category 7 and 8. Interpretation of Broad consent is that it is a system-wide program that allows institutions to track via a central system biospecimens and data for which individuals provide their broad consent, or decline, as well as the terms of the broad consent to determine which future research uses remain within scope. This interpretation aligns with the Health and Human Services (HHS) Secretary’s Advisory Committee on Human Research Protections (SACHRP) interpretation. Consequently, CSS is taking the same position as all of University of California, Children’s Hospital Orange County, Harvard, and Johns Hopkins and is not implementing Category 7 and 8 because CSS currently lacks a system-wide program for collecting broad consent.

Resources:

Purdue University - https://www.irb.purdue.edu/docs/new/sops-web.pdf

University of Austin Texas Broad Consent - https://research.utexas.edu/ors/human-subjects/irb-policies-and-guidance/policies-and-procedures/

IRB EasyEd Volume 2 Number 10 and Addendum

This is a new policy per the 2018 Common Rule Requirements.