Types of IRB Review | Emory University | Atlanta, GA (2023)

What is Free Research? Does the IRB have to review it?

Exempt investigations are projects that assistspecific federal criteriaand fall into one of the six exempt research categories listed below.Exempt research must be initially reviewed by the IRB, but is therefore exempt from further review. Projects that do not meet the criteria for human subjects research areeliminatedof the IRB review (see thenon-human subjectspanel below).

IRB staff or qualified members review applications to determine eligibility for exempt status.The researchers are not authorized to make this determination.. Although the IRB may determine that a project is exempt from full-scale IRB review, the IRB must still conduct a minimum of review ("exempt review") to ensure compliance with the ethical principles embodied in the Belmont Report: Respect for people, charity and justice. If the federal HIPAA privacy rule applies to the study, the IRB must also ensure compliance.

The IRB's impartial review focuses on informed consent and patient authorization materials and processes (which may include a HIPAA waiver). Please note that waiver research does not require an informed consent waiver or informed consent documentation from the IRB. On the other hand, only the IRB, acting as a privacy advisor, can grant a partial or full waiver of HIPAA patient authorization.

If you think your proposal may be exempt from IRB review, create a request in the eIRB as usual, get it approved by the head of the PI department or other authorized approver, and submit it. IRB staff will review the application and contact you if more information is needed to determine the exemption.

Exceptions to the Availability of Exemptions

Certain types of research involving human subjects arenot eligiblefor exempt determinations:

prisoners:research involving prisoners as human subjects isNoeligible for the exemption, except for surveys intended to involve a broader population, which only incidentally include inmates. "Inmates" are defined as "any person involuntarily confined or detained in a penal institution. The term is intended to include persons sentenced to such institution under criminal or civil law, persons detained in other facilities under laws or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution, and to persons detained pending charge, trial or sentencing.

FDA Regulated Research:research using a commercially available or approved drug, device, or biologic described in 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.

VA Studies:For AVAMC research or other VA-supported research not subject to FDA regulations, only the research categories set forth in theManual VHAcan be classified as exempt surveys.

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

exemption categories

Please see the note above regarding restrictions on exemptions for research involving children and prisoners.

Unless otherwise required by the Departments of Health and Human Services or other federal departments or agency heads, research activities in which the only participation of human subjects will be in one or more of the following categories are exempt from review of the IRB:

Environments, Educational Practices

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

Educational tests, surveys, interviews, observations*

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

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

(ii) Any disclosure of the responses of the human subjects outside of the survey would not put the subjects at risk of criminal or civil liability or be detrimental to the financial situation, employability, educational advancement or reputation of the subjects; either

(iii) The investigator records the information obtained so that the identity of human subjects can be readily verified, either 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).

*Children: When the study involves educational testing or observation of public behavior, the Emory IRB may grant a waived research determination for a protocol that includes children when the investigator is not involved in the activities being observed.

Research involving benign behavioral interventions

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 consents 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 way that the identity of the human subjects cannot be readily verified, either directly or through identifiers linked to the subjects;

(B) Any disclosure of human subjects' responses outside of the survey would not put the subjects at risk of criminal or civil liability or be detrimental to the financial status, employability, educational advancement, or reputation of the subjects; either

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

For the purposes of this provision,benign behavioral interventionsthey are short-lived, harmless, painless, non-physically invasive, are not likely to have a significant and lasting adverse impact on subjects, and the investigator has no reason to believe that subjects will find the interventions offensive or embarrassing.

As long as all of these criteria are met, examples of such benign behavioral interventions would include having subjects play an online game, solve puzzles in various noise conditions, or decide how to allocate a nominal amount of money received between themselves and another person.

(iii) If the investigation involvesmisleadingsubjects in relation to the nature or purposes of the research, this exemption does not apply, unless the subject consents to deception through a prospective agreement to participate in the research in circumstances in which he is informed that he will not have knowledge or be misled about the nature or purposes of the research.

Secondary research studies using personally identifiable information or biological samples

Secondary research for which consent is not required: Secondary research uses personally identifiable information or identifiable biological samples, if at least one of the following criteria is met:

(i) Privately identifiable information or identifiable biological samples are publicly available;

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

(iii) Research only involves the collection and analysis of information involving the researcher's use of identifiable health information when such use is governed by 45 CFR parts 160 and 164, subparts A and E, for purposes of "operations for health care" or "research" as those terms are defined in 45 CFR 164.501 or for "public health purposes and activities" as described in 45 CFR 164.512(b);(not applicable to Emory)o

(iv) Research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates personally identifiable information that is or will be maintained in information technology that is subject to and complies with section 208(b) of the Electronic Government Act of 2002, 44 U.S.C. 3501, if all personally identifiable information collected, used, or generated as part of the activity is 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 investigation was collected in accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 and following.

Educational tests, surveys, interviews, observations of public officials

Research and demonstration projects that are conducted or supported by a Federal department or agency, or that are subject to the approval of department or agency heads (or the approval of department heads or other subordinate agencies to which they have been assigned). delegated authority to carry out research and demonstration projects), and which are designed to study, evaluate, improve, or examine benefit programs or public services, including procedures for obtaining benefits or services under those programs, possible changes to, or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under these programs. Such projects include, but are not limited to, internal studies by Federal employees and studies under contracts or consultancy agreements, cooperative agreements, or grants. The exempt bills also include exemptions from mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

(i) Each Federal department or agency that conducts or supports research and demonstration projects shall establish, on a publicly accessible Federal website or in such other manner as determined by the head of the department or agency, a list of research and demonstration projects that the Federal Department department or agency conducts or supports under this provision. The research or demonstration project must be published on this list before beginning the research with human subjects.

(ii) [Reserved]

Food Taste and Quality and Consumer Acceptance

Food taste and quality evaluation and consumer acceptance studies,

• If healthy foods are consumed without additives or
• if a food is consumed that contains a food ingredient at or below the level and for use considered safe, or an agricultural chemical or environmental contaminant at or below the level considered safe by the Food and Drug Administration or approved by the Food and Drug Administration. Environmental Protection or the Food Safety and Inspection Service of the United States Department of Agriculture.

Broad Consent Exempt Categories(D7 and D8): Emory, as an institution, will not be implementing these categories at this time due to feasibility concerns.

Storage or maintenance for secondary research for which broad consent is required:

Storage or maintenance of personally identifiable information or identifiable biological samples for potential use in secondary research if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).

Secondary research for which broad consent is required:

Research involving the use of personally identifiable information or identifiable biospecimens for use in secondary research if the following criteria are met: (i) Broad consent was obtained for the storage, maintenance, and secondary research use of the personally identifiable information or identifiable biospecimens in accordance with §46.116(a)(1) through (4), (a)(6), and (d); (ii) Documentation of informed consent or waiver of consent documentation 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 determines 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 the return of individual research results to subjects as part of the study plan. This provision does not prevent a searcher from meeting the legal requirements to return individual search results.

Modifications are required only for exempt studies whensubstantive changeschanges are being made that may change the original review determination.

Examples of substantive changes are changes to:

• subject populations (such as adding a category of vulnerable population, such as minors or prisoners),
• data collection methods, o
• identifiability of the data (where the data was previously anonymized).

Examples of changes that are unlikely to change the exemption determination (therefore, can be made without further IRB review):

• change study instruments or recruitment materials
• change destination registration number
• add fully trained staff (unless a new staff member needs access to the eIRB study record)
• removal of personnel

If you are unsure, please post a comment or email your study analyst. (Remember to check the box to notify the IRB coordinator if you submit a comment.)

45 CFR 46.118Applications and proposals without defined plans to involve humans.

Certain types of grant applications, cooperative agreements, or contracts are sent to departments or agencies with the knowledge that problems may arise during the support period, but defined plans are not typically presented in the application or proposal. This includes activities such as institutional type grants, when the selection of specific projects is the responsibility of the institution; scholarships for research internships in which activities involving disciplines have not yet been selected; and projects in which human involvement will depend on carrying out instrumentation, previous animal studies or purification of compounds. These requests do not need to be reviewed by an IRB before an award can be made. However, except for research exempted or waived under§46.101(b)o46.101(yo), no human being may participate in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and the certification submitted, by the institution, to the department or agency.

additional guidance

• 45 CFR 46.101(b)
• Guidance Table for Determining Research Involving Non-Human Subjects, Waived, Expedited, or Full Review (PDF)