IRB Review Types

Emory IRB Full Board Review Criteria

Unless otherwise determined to be either Expedited or Exempt research, all human subject research protocols conducted at Emory are reviewed by a fully convened Institutional Review Board. Emory currently has six different boards which meet to review biomedical studies and a board specifically for socio-behavioral research, as well as a board which reviews non-compliance matters. IRB Meeting Schedule

Each Full Board protocol is assigned two reviewers based on those reviewers' background and expertise. Additional input may be sought, or required, if the research involves any Federally recognized vulnerable populations (see 45 CFR 46 subparts B, C, and D). During the meeting of the convened board, the primary reviewer is responsible for presenting general information about the study, including:

• Study goal
• Study design
• Study procedures
• Safety procedures and considerations
• Qualifications of the Investigators

Following the presentation of the study and discussion of the study by the Board, any voting member may make a recommendation for one of the following motions:

• Approval: For studies which meet Federal and Institutional criteria for approval as laid out in 45 CFR 46.111, including:
  • Risks to subjects are minimized
  • There is an appropriate risk-to-benefit ratio
  • The selection of subjects is equitable
  • Appropriate procedures are followed for obtaining and documenting informed consent, or waiving or altering informed consent documentation or procedures
  • The research plan has adequate provisions for monitoring the data collected in order to ensure subject safety
  • Additional safeguards are included to protect the rights and welfare of any vulnerable populations involved in the research
• Approval Pending: For studies which otherwise meet the above criteria for approval, but for which minor changes are required before approval may be granted. These changes can include anything from minor alterations to the study design to requests for the Investigator to re-write or re-word certain study documents, the consent form, for example. If the Board agrees, review of the Investigator's response to these requested changes may be undertaken by a Designated Reviewer, expediting the process.
• Deferred: For research proposals which require substantive or complex changes, or additional information, before they meet approval criteria. The Board may vote to defer a final decision of approval or disapproval until the Investigators have had time to adequate respond the Board's concerns. Once the Investigator has responded, the study will again be reviewed by a fully convened IRB.
• Disapproval: If a study does not meet approval criteria, and the Board cannot see that a deferral would change the situation, the Board may vote to disapprove a proposed study. If disapproved, no proposed study procedures may take place, and the study may not be re-submitted for review.
• Tabled: If, due to a loss of quorum, or lack of time or expertise, the Board is unable to provide adequate review of a study, then the review may be postponed until another meeting.

For the IRB to pass any of these motions, a majority of the voting members must agree.

Additional Considerations

As part of the review process, the Board may need to consider additional factors of the study including:

• Vulnerable Populations as codified in 45 CFR 46 subparts B, C, and D
  • Subpart B: Does the research involve pregnant women, fetuses, or neonates?
  • Subpart C: Does the research use prisoners as subjects?
  • Subpart D: Does the research involve children or wards?
    • If so, additional consideration of the consent/assent process is required.
• What is the risk level of the study?
  • Minimal
  • More than minimal
    • Certain studies may need to be reviewed more frequently than on an annual basis.
      
      
• Is their an IND or IDE?
  • If there is an IDE, what is the risk level of the device?

Other considerations, such as Emergency or Compassionate Use of a device or drug, or IND/IDE exemption, or waivers of consent or documentation of consent, may also arise. Each study represents a particular set of goals and procedures which can lead to unique situations for the subjects, and questions for the IRB Members.

Emory University IRB Expedited Review Applicability Criteria and Approval Categories

The Emory IRB uses the following guide to assist members in determining which studies may be reviewed using the expedited procedure. This guidance is derived from the list of categories published in the Federal Register. Federal regulations regarding Expedited review can be found in 45 CFR 46.110. The Department of Health and Human Services (DHHS) lists the expedited categories on their website alongside additional information on the review process.

Studies must meet all of the following applicability criteria:

• The current and future research procedures present no more than minimal risk to participants. Does not apply to category (8)(b)
• The identification of the participants or their responses will not reasonably place them at risk of criminal or civil liability or be damaging to their 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. Does not apply to category (8)(b)
• The research is not classified.

AND fit into one of the following categories:

Category (1):

(a):

Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.

(b):

Research on medical devices where:

• An investigational device exemption application (21 CFR Part 812) is not required; OR
• The medical device is cleared/approved for marketing; AND
• The medical device is being used in accordance with its cleared/approved labeling.

Category (2):

(a):

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, non-pregnant adults where:

• The participants weigh at least 110 pounds; AND
• The amounts drawn will not exceed 550 ml in an 8-week period; AND
• Collection does not occur more frequently than 2 times per week.

(b):

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from other adults and children considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected where:

• The amount drawn will not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period; AND
• Collection will not occur more frequently than 2 times per week.

Category (3):

Prospective collection of biological specimens for research purposes by noninvasive means.

Category (4):

Collection of data through noninvasive procedures routinely employed in clinical practice where:

• The procedures do not involve general anesthesia or sedation; AND
• The procedures do not involve x-rays or microwaves; AND
• If medical devices are employed, they are cleared/approved for marketing.

Category (5):

• Research involving materials (data, documents, records, or specimens) that have been collected; OR
• Research involving materials (data, documents, records, or specimens) that will be collected solely for non-research purposes (such as medical treatment or diagnosis).

Category (6):

Collection of data from voice, video, digital, or image recordings made for research purposes.

Category (7):

• Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior); OR
• Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Category (8):

Continuing review of research previously approved by the convened IRB as follows:

(a):

• The research is permanently closed to the enrollment of new participants; AND
• All participants have completed all research-related interventions; AND
• The research remains active only for long-term follow-up of participants.

or (b):

• No participants have been enrolled; AND
• No additional risks have been identified.

or (c):

• The remaining research activities are limited to data analysis.

Category (9):

• Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified

What is Exempt Research? Does the IRB Have to Review It?

Exempt research are projects that meet specific federal criteria and fall into one of the six categories of Exempt research listed below. Exempt research must be initially reviewed by the IRB, but is then exempt from further review. Projects that do not meet the criteria for human subjects' research are excluded from IRB review (see the Non Human Subjects panel below).

Qualified IRB staff or members review applications to determine eligibility for exempt status. Investigators are not authorized to make this determination. Although the IRB may determine that a project is exempt from full-scale IRB review, it must still conduct a modicum of review ("exempt review") to ensure compliance with the ethical principles embodied in the Belmont Report: respect for persons, beneficence, and justice. If the federal HIPAA Privacy Rule applies to the study, the IRB must ensure compliance with that as well.

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

If you think your proposal may be exempt from IRB review, please create an application in eIRB as usual, obtain the approval of the PI's department chair or other authorized approver, and submit. The IRB staff will review the application and follow up with you if more information is needed to make the exempt determination.

Modifications are only required for exempt studies when substantive changes are being made that could alter the original review determination.

Examples of substantive changes are changes to:

• subject populations (like adding a vulnerable population category, such as minors or prisoners),
• data collection methods, or
• identifiability of data (where data were previously de-identified).
• addition of Federal funding (see guidance on grant additions)
• Addition of an international study site
• Updates to study staff when the team member needs access in eIRB.

Examples of changes unlikely to alter the Exempt determination (so can be done without further IRB review):

• altering study instruments or recruitment materials
• changing the target enrollment number
• adding fully trained staff (unless a new staff member needs access to the study record in eIRB)
• removing staff

If unsure, log a comment or email your study analyst. (Remember to check the box to notify the IRB coordinator if logging a comment.)

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. Detainees in administrative cases (such as immigration or deportation) are not considered detainees for this purpose, according to guidance the Emory IRB has obtained from DHHS.

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.

VA Studies: For AVAMC Research or other VA-supported research that is not otherwise subject to FDA Regulations, only the categories of research set forth in the VHA Handbook may be classified as exempt research.

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.

Categories of Exemption

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

Unless otherwise required by Health and Human Services or other federal 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 IRB review:

Educational Settings, Practices

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.

Educational Tests, Surveys, Interviews, Observations*

Research that only includes interactions involving the use of 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).

*Minors: When the study involves educational tests or the observation of public behavior, the Emory IRB may grant an exempt research determination to a protocol that includes minors when the investigator does not participate 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 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).

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.

Secondary Research Studies using Identifiable Private Information or Biospecimens

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); (not applicable at Emory) 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.

Educational Tests, Surveys, Interviews, Observations of Public Officials

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 website 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]

Taste and Food Quality and Consumer Acceptance

Taste and food quality evaluation 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.

Broad consent exempt categories (D7 and D8): Emory as an institution will not implement these categories at this time due to practicability issues.

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).

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 46.118 Applications and proposals lacking definite plans for involvement of human subjects.

Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However, except for research exempted or waived under §46.101(b) or 46.101(i), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the department or agency.

Additional Guidance

• 45 CFR 46.101(b)
• Guidance Chart for determining Not Human Subject Research, Exempt, Expedited or Full Board Review (PDF)

Projects that either do not involve human subjects or fail to meet the definition of research are excluded from IRB review. This is not the same as exempt research.

Is an activity research involving human subjects?

To determine whether or not IRB review is required, the first step is to determine whether or not the study is research. The next step is to determine whether or not the study involves human subjects. Some projects that may require careful consideration for this type of determination include: oral histories, case studies, quality improvement studies, etc. Typically IRB staff will assist the researchers in making this decision; IRB members are usually consulted only in situations that are unclear.

Please see below for the regulatory definitions of research and of human subjects.

Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. 45 CFR 46.102(d)

Human subject: a living individual about whom an investigator (whether professional or student) conducting research obtains

1. Data through intervention or interaction with the individual, OR
2. Identifiable private information (See List of Possible Identifiers (PDF))
3. 45 CFR 46.102(f)(1),(2)

Intervention: includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. 45 CFR 46.102(f)(1)

Identifiable private information: includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. 45 CFR 46.102(f)(2)

Human Subject Decision Charts

The Office for Human Research Protections (OHRP) provides their Human Subject Regulations Decision Charts as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.

The Emory IRB has compiled a quick reference chart on IRB review types (PDF) for researcher use.