551. Review Types
Updated July 1, 2019
This policy identifies the available review types and describes the applicable circumstances under which each review type is used.
Research Integrity (RI) staff will select the applicable Review Type from the Review and Minutes page in IRBNet (as specified below). The selected review type will auto-populate when the meeting minutes are generated. NOTE: Depending upon the outcome of the review, RI staff may need to update the Review Type in IRBNet.
Requests to Use the University IRB: Circumstances may arise in which an investigator at an external site that does not have an IRB, or an external investigator collaborating on a University research project asks to use the University IRB as the Reviewing IRB. Such requests are reviewed as exempt, or by expedited review procedures or at a convened IRB meeting according to the relevant policy as described below.
Full Committee Review
Full committee review is required for new projects that involve any of the research activities itemized below; and continuing reviews and reviews of amendments for research projects previously approved at a convened IRB meeting.
Research Activities that Require Review at a Convened IRB Meeting (i.e., Full Committee Review)
- Research activities present greater than minimal risk to participants. (Federal regulations do not define greater than minimal risk. Risk is assessed by extrapolating from the definition for minimal risk; (see Policy Manual Definitions.)
- Investigator Revisions in response to convened IRB deferred review of new projects, continuing review, or amendments. At the discretion of RIO Staff, the revisions may be sent to the primary reviewer or IRB Chair for preliminary confirmation of completeness, before the revisions are placed on the agenda for review at the next convened meeting.
- The project is classified research (see Policy Manual Definitions ).
- The research involves an FDA-regulated test article (e.g., investigational drug, biological product, or device). .
- Continuing review of research previously approved at a convened meeting unless expedited review category 8(b) or 9 applies (see DHHS Categories of research eligible for review by expedited procedures).
- Amendments to research previously approved at a convened meeting.
NOTE: At the discretion of the IRB-member reviewer, minor amendments to research previously approved at a convened meeting may be reviewed by expedited procedures if the changes do not affect criteria for IRB approval, and fall within the list of categories of research eligible for expedited review.
- Amendments to research previously approved by expedited procedures if an IRB-member determines the changes may increase participant risk to greater than minimal, decrease research benefits, or involve research activities that are not among those eligible for expedited review.
- Allegations of serious or continuing noncompliance.
- Unanticipated problems involving risks to subjects or others.
- Suspension or termination of research activities.
- Sponsor, investigator or other regulatory body requests for suspension or termination of research activities.
- Other submissions that warrant review and discussion by the convened IRB, as determined on a case-by-case basis.
Expedited reviews are completed by one or more IRB members and may be used for new projects involving research activities as itemized below; and continuing reviews and reviews of amendments for projects initially reviewed and approved by expedited procedures; and continuing reviews and reviews of amendments for research previously approved at a convened meeting (as specified below).
NOTE: Under the University's IRB Flexibility Policy (IRB-Flex), minimal risk research that is not conducted, supported, or otherwise subject to regulation by a federal agency; and does not involve prisoners or incomplete disclosure may be eligible for Flex-Exempt Review (as described in the next section).
Research Activities that May be Reviewed by Expedited Procedures
- Research activities that present no more than minimal risk to participants (see Policy Manual Definitions for minimal risk).
- Research activities that are represented by one or more of the DHHS Categories of research eligible for review by expedited procedures.
- Research activities in which reasonable and appropriate protections are implemented to reduce risks related to invasion of privacy and breach of confidentiality to no greater than minimal, when identification of participants and disclosure of their responses may place them at risk of criminal or civil liability; damage their financial standing, employability, insurability, reputation; or be stigmatizing.
- In limited circumstances (see Continuing Review, Expedited policy), continuing reviews of research initially approved by expedited procedures when the IRB reviewer requests and justifies a need for ongoing expedited review.
- Minor Revisions submitted by investigators following IRB Action Approved with Conditions.
- Minor amendments for research previously approved at a convened IRB meeting (see Policy Manual Definitions for minor amendments). Examples:
- Addition or removal of research personnel (if not the PI, may receive administrative review )
- Changes to study sites (may receive administrative review)
- Edits to correct spelling or grammar, or to update telephone numbers or email addresses;
- Variations to the amount of blood being drawn for a research sample, as long as these do not exceed the thresholds for blood draws as described under expedited review categories 2(a) and (b); o Change to methods for presenting materials such as from interview to questionnaire format;
- Reductions in procedures that would reduce risks to participants without concomitantly reducing benefits;
- Addition of new advertisements; or
- Increasing the duration of a study
- Increasing enrollment numbers for the study.
- Continuing review of research previously approved at a convened IRB meeting when research activities are in one of the categories eligible for expedited review: 8(b) or 9. For details, see DHHS Categories of research eligible for review by expedited procedures.
- Under flex policy, non-invasive collection of biospecimens in expedited category 4 may be expanded to include skin biopsy (without sutures); ionizing radiation (<100 mrem/yr [1 Sv]); blood draws via indwelling catheter (regardless of frequency); blood draw 5 mL/kg/day or 9.5 mL/kg/8 weeks; additional collection of blood, cerebrospinal fluid, bone marrow during a clinically indicated procedure; additional endoscopic gastro-intestinal biospsies
Qualifying research activities may be exempt from federal regulations for the protection of human subjects (see 45CFR46.101) with the following caveats:
- An IRB member determines a particular research activity is exempt from the federal regulations for the protection of human subjects.
- The RI may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the University comply with some or all of the federal regulations for the protection of human subjects.
- University and affiliate researchers conducting human research must comply with pertinent federal, state and local, and foreign laws and regulations that apply to the research activities and which provide additional protections for human subjects.
- When University and affiliate researchers conduct exempt research in foreign countries, the RIO requires compliance with applicable US federal regulations in addition to those of the host country.
- IRB members may consider Flex-Exempt Review with equivalent protections for minimal risk human subject research when that research is not conducted, supported, or regulated by a federal agency and does not involve prisoners or incomplete disclosure/deception.
Conditions for Human Research Activities to Be Exempt
- Research activities as ionitially proposed or if modifications to ongoing exempt research are later proposed present no more than minimal risk to participants (see Policy Manual Definitions for minimal risk).
- Research activities as initially proposed or if modifications to ongoing exempt research are later proposed humans in one or more of DHHS categories for exempt research.
- The research does not involve prisoners as an intended population.
- Research involving observations of public behavior does involve children unless the investigators do not participate in the activities being observed.
- Research involving educational tests, surveys, interviews collecting identifiers and for which disclosure of information outside the research poses potential risks to participants does not involve children.
- Research involving benign behavioral interventions is limited to adults as the population.• Research involving benign behavioral interventions with collection of identifiers where the IRB conducts a limited review to confirm there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data including when changes are proposed in the privacy and confidentiality measures.
- Proposed changes in the research activity continue to meet no more than minimal risk to participants.
NOTE: FDA-regulations for exempt research differ from the DHHS categories. Refer to the FDA Exempt Categories policy for details.
DHHS Categories for Exempt Research (per §46.101 item (b))
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.
Complete Exempt Core Application Research with Participants
DHHS-Exempt 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:
(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).
Complete Exempt Core Application Research with Participants
(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:
(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).
(ii) 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.
Complete Exempt Core Application Research with Participants
DHHS-Exempt 4: 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 HIPAA, for the purposes of "health care operations" or "research" or for "public health activities and purposes"; 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 non-research activities, if the research generates identifiable private information stored on systems maintained according to applicable privacy regulations.
Complete Exempt Core Application Review of Existing Records or Specimens
DHHS-Exempt 5: 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]
Complete Exempt Core Application Research with Participants
DHHS-Exempt 6: Taste and food quality evaluation and consumer acceptance studies if (a) wholesome foods without additives are consumed; or (b) a food is consumed that contains a food ingredient or agricultural chemical or environmental contaminant which is or below the level and for a use found to be safe by the FDA, or approved by the EPA or Food Safety and Inspection Service of the USDA.
Complete Exempt Core Application Research with Participants
The following DHHS-Exemption Categories 7 and 8 reference broad consent for secondary research with identifiable private information or identifiable biospecimens. DHHS offers category 7 and category 8 for secondary research. Our local policy is to review secondary research under category 4. Use of exemption category 7 and 8 may be phased in later upon receipt of guidance from federal agencies after January 2018. Our Policy 325 addresses options for consent and does not include Broad Consent. Where possible, RI expects that researchers who anticipate secondary use of such materials will obtain prospective consent or tiered consent from participants. The consent should include the requisite detail to allow participants to make an informed decision about primary and subsequent uses of these materials unless such research meets Exempt category 4 or Expedited category 5.
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.
Research activities that do not require an assessment of the IRB criteria for approval may be reviewed and acknowledged by trained RI staff, an IRB member or Chair, or the Research Compliance Officer (RCO) as applicable. These include but are not limited to the following activities:
Annual Status Reports: Annual status reports on research reviewed by expedited procedures receive administrative review unless the reviewer has requested and justified ongoing expedited review at initial review. See the expedited continuing review policy for details on when studies will continue to receive expedite review.
Changes to Study Sites: Changes to study sites that do not include the addition of vulnerable populations.
Certificates of Confidentiality: Once approved by the issuing agency, PIs must submit documentation of Certificates of Confidentiality to the IRB for administrative review and acknowledgement.
Changes in Study Personnel: Routine changes to study personnel (e.g., addition or removal of researchers) constitute administrative actions that only require confirmation that training requirements are met and that relevant researcher forms and recruitment and consent materials are updated correctly to reflect the changes (as appropriate). Changes in the PI receive expedited review as project amendments by an IRB member. The IRB member will assess the PI's qualifications for overseeing the research.
Closures: Investigator requests to close research projects receive administrative review by RI staff to confirm the request is complete and compliant. Expirations of IRB approval occur automatically in IRBNet by notice to the PI that IRB approval or exempt status has expired and all research activities involving human participants must cease.
Determinations of Not Human Subjects Research: New projects submitted for determinations of human subject research, and projects submitted for: Exempt or Expedited Review when these do not meet the federal definitions of research or involve human subjects as defined by the regulations.
Emergency Use of a Test Article: The IRB Chair or other designated IRB Member administratively reviews and acknowledges documentation from a clinician who is reporting or proposing use (if time is not sufficient to convene a quorum of the IRB) of an FDA-regulated test article in a life-threatening or severely debilitating situation. IRB Chair/Member may seek counsel from a physician or pharmacist as needed.
External Site Approval or Permission to Recruit: RI staff administratively review and acknowledge documentation from external sites granting approval or permission to proceed with the research (e.g., WCSD) or to recruit at the site (e.g., TMCC).
Preliminary Review of Problem Reports: The IRB Chair or RI Director complete an administrative review to evaluate problem reports, or requests for suspensions or terminations to determine if immediate action is warranted and to make recommendations for Full Committee Review by the convened IRB or Expedited Review by a subcommittee of the IRB.
Routine or Required Sponsor Amendments: The RI RCO or an IRB member administratively reviews routine (e.g., annual) amendments to sponsor protocols or investigator brochures when the amendments do not identify changes to participant risks or benefits, or require substantive changes to the IRB application or consent materials or processes. Sponsor amendments with no changes to participant risks that require minor changes to study materials may receive expedited review by the IRB as an Amendment. Sponsor amendments that are substantive, or that identify increased risks will receive review as an Amendment at the next convened IRB meeting.
Sponsor Safety Reports: The RI RCO administratively reviews and acknowledges receipt of routine safety reports from sponsors. When reports do not identify changes to participant risk, or require substantive changes to an IRB application, or consent processes or materials, PIs may submit the reports at the time of continuing review.
Safety reports identifying increased risks or requiring substantive changes to an IRB application, or consent processes or materials will be reviewed as an Amendment or Unanticipated Problem (as indicated by the content of the safety report and according to IRB policy) at the next convened IRB meeting.
Use of External IRBs: An IRB member administratively reviews and acknowledges requests by University and affiliate investigators for review by an external IRB. At its discretion, RI may require IRB review for investigators to use an external IRB. Once the Administrative Review is complete, the PI will receive written acknowledgment of the external IRB as the IRB of Record or notice that review by the University IRB or by both IRBs is required.
This review type is reserved for specific situations. For example, facilitated review may apply when an external IRB, designated as the Reviewing IRB, asks the University IRB to augment the external IRB's review process