Levels of IRB Review

The Final Rule makes significant changes to the categories of research that are exempt from the reach of the Common Rule.

There are now 8 exempt categories. (Please see below.)

Please note: Exceptions to Availability of Exemptions

Certain kinds of research with human subjects are not eligible for exempt determinations:

Prisoners: research involving prisoners as human subjects is not eligible for exemption except for research aimed at involving a broader subject population that only incidentally includes prisoners.  “Prisoners” are defined as “any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.  

FDA-regulated Research: Research using a drug, device or biologic, approved for marketing or not, outlined under 21 CFR 312 (drugs), 21 CFR 812 (devices), and 21 CFR 600 (biologics). FDA regulations for informed consent (21 CFR 50) and Institutional Review Boards (21 CFR 56) also apply.

Minors (Children): Most of the exemption categories can apply to research with minors, except for secondary research involving identifiable data or specimens, surveys, and interviews. Also, research involving educational tests or observations of public behavior can only be exempt when there is no interaction with the researcher.

Summary of changes to exempt categories:

One category has been deleted (“Educational tests, survey and interview procedures, or observation of public behavior in public officials”); two existing categories have been expanded to allow collection of sensitive identifiable information with limited IRB review (“Normal educational practices in commonly accepted settings” and “Educational tests, surveys, interviews, observation of public behavior”); and three new categories have been added (“Benign behavioral interventions with adults,” “Storage or maintenance of identifiable private information or identifiable biospecimens for secondary research” and “Research involving use of identifiable private information or identifiable biospecimens stored pursuant to a broad consent”).

Exempt Research Revisions

Exemption 1 – Modified

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices, so long as the research is not likely to adversely affect students’ opportunity to learn required educational content or the assessment of educators who provide instruction.

What’s new?

• Now must consider “adverse affects” on student learning of required educational content or on assessment of educators.

Exemption 2 – Modified

The exemption applies to 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) uninfluenced by the investigator if at least one of three criteria is met:

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

 What’s new?

• Projects collecting sensitive and identifiable data may now qualify as exempt. The IRB review must make sure that there are adequate provisions for protecting privacy and maintaining confidentiality.
• Clarifies that the exemption does not apply to projects involving:
  • Interventions
  • Collection of biospecimens
  • Linking to additional personally-identifiable data
  • Children (except for educational tests or some public observations)

Exemption 3 – New

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject.  Benign behavioral interventions are defined as being 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.  The IRB must conduct a limited IRB review to determine that there are adequate provisions for protecting privacy and maintaining confidentiality.  Examples:  subjects play an online game, solve puzzles under various noise conditions, or decide how to allocate a nominal amount of received cash between themselves and someone else. Includes authorized deception.

What’s new?

• This exemption is completely new.
• Limited to research with adults

What is a benign behavioral intervention?

• Brief in duration
• Harmless and painless
• Not physically invasive
• Not likely to have a significant adverse impact on subjects
• Not offensive or embarrassing

• Information is collected via
  • Verbal or written responses (surveys/interviews)
  • Data entry
  • Observation of subject (including audiovisual recording)
• Does not permit data collection via physical procedures
  • Physical sensors (e.g. blood pressure monitors, EEG, FitBits)
  • Minimally invasive procedures (e.g. blood draw or saliva collection)
• No deception, except where the subject is told that they will be unaware or misled about the nature or purposes of the research and they agree. Must obtain “prospective agreement to the intervention and information collection”
  • Debriefing still encouraged

Exemption 4 – Modified

Secondary research use of identifiable private information and identifiable biospecimens for which consent is not required, when:

• The identifiable private information or identifiable biospecimens are publicly available;
• The information is recorded by the investigator in such a way that the identity of subjects cannot readily be ascertained, and the investigator does not contact subjects or try to re-identify subjects;
• The secondary research activity is regulated under HIPAA;
• The secondary research activity is conducted by or on behalf of a federal entity and involves the use of federally generated non-research information provided that the original collection was subject to specific federal privacy protections and continues to be protected.

The goal of the exemption is to facilitate secondary research using identifiable private information or identifiable biospecimens that have been or will be collected or generated for non-research purposes or from research studies other than the proposed research study.

What’s new?

• No longer limited to retrospective data review
• Permits secondary use of identifiable protected health information (PHI) (with HIPAA privacy board review)

Exemption 5 – Modified

Public benefit and service programs and research and demonstration projects conducted or supported by a federal department or agency.

Exemption 6 – Unchanged

Wording directly from Final Common Rule

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.

Exemption 7 – New Belmont IRB RECOMMENDATION – NOT TO IMPLEMENT

The storing and maintaining identifiable private information or identifiable biospecimens for secondary research use.  Requires that an IRB conduct limited IRB review to make the following determinations:

• Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained;
• Broad consent is appropriately documented or waiver of documentation is appropriate, and
• If a change is made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, adequate provisions must be in place to protect the privacy of subjects and to maintain the confidentiality of data.

Exemption 8 – New Belmont IRB RECOMMENDATION – NOT TO IMPLEMENT

Applies to the secondary research use of identifiable private information and identifiable biospecimens for specific secondary research studies. Secondary research under this exemption would generally be conducted with the information or biospecimens stored and maintained under the exemption 7.  Requires:

• Broad consentfor the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens, and
• Documentation of informed consent or waiver of documentation of consent was obtained

To qualify for expedited level review, research must fall into any of nine (9) regulated categories. See https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html for complete information about the expedited categories.

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the expedited categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

The categories in the expedited list apply regardless of the age of subjects, except as noted.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review.

See Protocol Review and Timelines for more information.

Proposed research studies involving human subjects that do not qualify for exempt or expedited level review must be reviewed by the IRB at a convened meeting (full board level review). Studies requiring full board review present more than minimal risk to subjects, and/or involve vulnerable populations, such as children, prisoners, institutionalized individuals, or persons with diminished capacity to consent (e.g., Alzheimer patients).

Full board reviews are not common at Belmont. Our IRB typically has one full board review a year. If you are planning on submitting an application that you think will require a full board review, please contact the IRB chair for guidance and support in this process and see Protocol Review and Timelines for more information on the review process.