IRB Review Procedure

All human subjects research, and all other activities, which in part include human subjects research, involving service recipients/participants in TDMHSAS facilities (i.e., the RMHIs) and/or programs funded by or through TDMHSAS must be reviewed and/or approved by the TDMHSAS IRB. Program evaluation activities may not necessarily require IRB review. Program evaluation activities are typically undertaken to examine the effectiveness of a specific service, practice, or program. However, if, from the outset, information from the program evaluation activity is going to be generalized to other programs, it is human subjects’ research and should be submitted to the IRB. Such is not the case for most program evaluation activities. Researchers are asked to consult with the IA if they have questions about how to proceed.

The IRB must review all human subjects research if one or more of the following apply:

• The research involves TDMHSAS service recipients/participants, their records, or biological specimen.
• The research is sponsored by TDMHSAS.
• The research is conducted by or under the direction of any staff, student, or agent of TDMHSAS in connection with his or her departmental responsibilities.
• The research is conducted by staff in a State-funded program for which TDMHSAS has monitoring responsibilities.
• TDMHSAS receives a direct Federal award to conduct human subjects research or there may need to be an IRB requirement as part of the evaluation activities, despite all activities involving human subjects being carried out by a subcontractor or collaborator.
• IRB review and/or approval will also be required when data originally collected for non-research purposes will be used in research.
• Sometimes information (including data) that has been collected for program evaluation purposes, e.g., will later be used to generalize to similar programs. In this case, the IRB can review the proposal as research involving secondary use of existing data. Per the 2018 Common Rule, secondary research may include information and/or biospecimens that were not in existence at the start of the research but will be collected for clinical purposes in the future. If collected data were not identifiable, efforts cannot be undertaken to identify them. At the very least, the IRB may perform limited review. It will be up to the IRB to determine whether the after-the-fact submission will be accepted. The IRB may refuse to review the proposal, especially if there are indications that avoiding the IRB was the reason a proposal was not submitted early during project implementation.

Types of Reviews

The TDMHSAS IRB will conduct initial, limited, and continuing reviews, as deemed appropriate, in addition to reviewing amendments for currently reviewed and/or approved research.

Initial Review

Assumes exemption has been ruled out or that limited review was deemed necessary.

Initial review encompasses the first full review of a research proposal/other research activities by the TDMHSAS IRB. The review may be undertaken for any research activity.  Requests for initial review must conform to and comply with appropriate laws and regulations. For example, the research must conform to policies outlined in 45 CFR Part 46, Protection of Human Subjects. In addition, the research must comply with current TDMHSAS policies regarding the Health Insurance Portability and Accountability Act (HIPAA), Title 33, and 42 CFR Part 2 where applicable.  Requests to conduct research requiring initial review must be in writing and include a cover letter addressed to the TDMHSAS-IRB Chairperson.  A concise, yet thorough, description of the study should be submitted despite the fact that the study may be exempted. The IRB needs to have a “full picture” of the study, including:

• Study title;
• Study purpose and objectives;
• Research questions or hypotheses;
• Research design including information on the target population - study participants and recruitment;
• Research method(s) including instrumentation (commercial or locally developed) and measures;
• Research ethics including informed consent procedures and forms that comply with 45 CFR §§ 46.116-117 (Research ethics should specifically incorporate how the researcher will obtain informed consent and protect the confidentiality of participants throughout the study period. A copy of all informed-consent forms for study participants and any other pertinent forms and assessment tools must be submitted at the time of the request.);
• How the data will be collected and protected; participant coding, and how confidentiality will be maintained; and
• Data analysis.

Proposals must address informed consent as well as assent if children, i.e., persons younger than 18 years of age will be involved in the research. The informed consent document should, at minimum, include the following information:

• Statement that the study involves research, the purpose of the research and the expected duration of the participant’s involvement in the research, a description of the procedures to be followed and identification of any procedures that may be experimental.
• Discussion of any foreseeable risks or discomforts to the subject.
• Discussion of any benefits to the participant.
• Disclosure of any alternative treatments that might be advantageous to the participant.
• Statement indicating the extent to which confidentiality of the data will be maintained.
• Explanation of whether any compensation and medical treatment might be available to the subject if injury occurs, and if so, what compensation and/or medical treatment is available or where further information may be obtained.
• Explanation of whom to contact for further information.
• Statement that participation is voluntary and refusal to participate or discontinue participation at any time will not result in penalty or loss of benefits or services to which the participant and/or his or her family is otherwise entitled.

The TDMHSAS IRB voted not to allow the broad consent option for researchers in consent documents so any Waiver of Consent/Authorization request requires the PI/researcher to demonstrate to the IRB that the:

• Research involves no more than minimal risk to participants;
• Research cannot practicably be carried out without using the identifiable information/specimens;
• Waiver does not adversely affect the welfare and/or rights of participants; and
• Participant and/or his or her legally authorized representative is offered pertinent information regarding the study when completed, if appropriate.

All initial requests to conduct research associated with the RMHIs must have written executive approval. Permission to conduct the research can be provided by the TDMHSAS Commissioner/Deputy Commissioner, or their designees. Written approval can be provided electronically or in hard copy.

Initial research submitted by some entity other than the PI must have written approval from the PI prior to review by the TDMHSAS IRB. Written approval can be provided electronically or in hard copy.

Initial research being conducted by a researcher affiliated with an academic institution must further provide institutional IRB approval prior to submission to the TDMHSAS IRB.

Continuing Review

Required of studies reviewed under the pre-2018 Common Rule or deemed necessary at initial, limited, and/or subsequent reviews under the revised 2018 Common Rule.

Proposals requiring continuing review have been previously reviewed and approved by the TDMHSAS IRB. In most cases, participant enrollment will be ongoing at the time of the continuing review.  Continuing review may also involve:

• Exempted research where routine follow-up of privacy and confidentiality protections was required by the IRB; and/or
• Studies reviewed and approved in advance of January 21, 2019, where annual continuing review was the standard.

Continuing review will be conducted at intervals appropriate to the degree of risk but at least annually.

Limited IRB Review

Related to concerns regarding privacy and/or confidentiality for specified research categories that have been exempted per the revised 2018 Common Rule.

For this option, collected information (data and/or biospecimens) tends to be identifiable and/or sensitive, though risk is minimal.  The TDMHSAS IRB will determine the scope and responsibility for limited IRB review. Limited IRB review will be a function of the nature of the study and adequate protections as perceived by the TDMHSAS-IRB membership. Ongoing review (i.e., the equivalence of continuing review) to ensure adequate privacy and confidentiality provisions may be recommended by the membership.

Review of Amendments to Currently Approved Research

Includes research obtaining Initial, Limited, or Continuing review.

It may become necessary for PIs/researchers to amend their research proposal. These amendments are typically associated with changes to the protocol. Sometimes the changes are minor and do not substantially alter the risk level of the study. However, changes can be substantive and result in significant changes in the risk level of the research. Nevertheless, any change requires an amendment(s) to the research proposal and IRB approval prior to implementation.

Formal submission is required for amendments, major or minor. The cover letter should indicate which components are being amended and why. Amendments requiring changes to the protocol or forms should be so documented; use “Track Changes”.  Level of risk and/or other factors associated with the changes will determine whether the amendment request will be expedited or handled at a convened meeting. Changes in PI will likely be expedited. More substantial changes, especially changes that may impact risk level, will likely be handled at a convened meeting. 

An amendment(s) cannot be implemented until IRB approval (expedited or full review) has been rendered.  Review dates and/or version/revision numbers on stamped documents for amendments will change. However, the oversight expiration date will remain unchanged unless the amendment review is part of a scheduled continuing review.

Review Processes

Initial review, continuing review, limited review, or review of amendments may be conducted by the full Board or as few as a single TDMHSAS IRB member.

Full Review

(i.e., full/convened Board meeting)

In most cases, reviews of research involving vulnerable populations or service recipients at the RMHIs regardless of the level of risk, will be conducted at a full Board (convened) meeting.  The types of research which may require full review by the TDMHSAS IRB include, but are not limited to:

• Research that requires access to identifiable PHI where the identifiers are to be included in the data maintained by the researcher; and
• Research that involves obtaining information through intervention or interaction with the individual other than those qualifying for exemption.
• Studies that involve more than minimal risk. OR
• Studies involving complex research designs, deception, and/or vulnerable populations.

Full review will require the presence of at least a quorum (majority) of the voting membership. Further, at least one member in attendance must be a nonscientist. Members will meet in person, virtually, and/or through a conference line. The meeting will be convened in a scheduled location at a scheduled time and the quorum (majority) should be in attendance during discussion and vote on each request (proposal) for review at the meeting.  Discussions and votes taken during the full review (convened) meeting will be recorded and included in minutes.

• Members with conflicting interests must recuse themselves from voting.
• Members will also have the opportunity to abstain during a vote. A member only minimally involved in the research may abstain from voting.
• Members may vote to approve, approve with conditions, disapprove, table (postpone), closeout, suspend, and/or terminate research activities.

If conditional approval is recommended, conditions to be addressed by the PI will be delineated by the membership during the meeting.  The IRB Administrator will relay the Board’s decision to the PI within ten (10) working days of the convened meeting. This decision may be communicated electronically and/or in hard-copy format.  If conditions are indicated, the PI will have up to thirty (30) days from receipt of the conditional requirements to satisfactorily address them.  Conditions of approval are typically reviewed by a single member, usually the IRB Administrator, and then discussed with the TDMHSAS-IRB Chairperson. On occasion, an additional member or two might be asked to review whether conditional requirements were satisfactorily met. The TDMHSAS-IRB Chairperson will determine if more than one reviewer is needed.  The reviewer(s) will have ten (10) working days from receipt of responses to conditions for review and reporting back to the TDMHSAS-IRB Chairperson.  Turnaround from the TDMHSAS-IRB Chairperson is typically a one-to-two-day process. (The Co-Chairperson will fulfill this responsibility if the Chairperson is not available.)  Once the TDMHSAS-IRB Chairperson (or Co-Chairperson in the absence of the Chairperson) approves the decision of the reviewer(s), the IRB Administrator will have (10) working days to share results with the PI. This final decision may be provided electronically and/or in hard copy. TDMHSAS IRB’s Adverse Event/Unanticipated Problem form will accompany each approval message or letter to the PI. This form should be used to report serious adverse events/unanticipated problems to the Board as stipulated in the Common Rule.

Expedited Review

Expedited reviews will be restricted to minimal risk studies and to review of amendments requiring minor changes and no increase in risk level. Some studies that could undergo expedited review, however, may be reviewed during a full Board (convened) meeting.  The TDMHSAS-IRB Chairperson or designee may elect to conduct expedited review of submitted research proposals. Review under the expedited procedure gives full IRB authority to the reviewers, except the ability to disapprove the research (To disapprove research requires review by a fully convened TDMHSAS IRB.)  Requirements of informed consent are still applicable under the expedited review procedure.  An expedited review must fulfill all review requirements contained in 45 CFR § 46.111 and its subparts and any subsequent revisions and amendments.

The types of research which may qualify for expedited review include research that presents no more than minimal risk to human participants and involves only procedures from one of the following categories:

• Clinical studies of medical devices and drugs that do not require an investigational new drug or device exemption application;
• Collection of blood samples by ear stick, heel stick, finger stick, or venipuncture that do not exceed specified amounts in an eight-week period or occur more often than twice weekly;
• Prospective collection of biological specimens for research purposes by nonintrusive means;
• Routine, nonintrusive data collection that is typically employed in clinical settings (Medical devices must be pre-approved for marketing);
• Research involving de-identified or non-identifiable data, documents, records, or specimens that have been or will be collected solely for non-research purposes;
• Data collection from voice, video, digital, or image recordings made for research purposes;
• Research on group or individual behaviors or characteristics like cultural beliefs or practices, social behavior, etc., or research that uses survey, interview, focus group, program evaluation, human factors evaluation, oral history, or quality assurance methods; or
• Exclusions from expedited review include research where participant identification and/or responses would reasonably place participants at risk of criminal or civil liability or be damaging to them as well as classified research. (Expedited review may be used if risks associated with invasion of privacy and breach of confidentiality would be minimized.)

An IRB may also use the expedited review for research for which limited IRB review is a condition of exemption under 45 CFR § 46.104(d)(2), (3), (7), and (8).  Expedited review will typically involve a single member, usually the IRB Administrator. One or more IRB members may be involved in the review, but not the full Board. Reviewers cannot have a conflicting interest in the request (proposal).  Expedited review will follow the same process and time frame as full review.

Waiver of Consent/Authorization

 If review warrants a Waiver of Consent/Authorization, the waiver form and PI Assurance Form must be completed.  Reviewer decisions involving the Waiver of Consent/Authorization and PI Assurance Form are handled in the same way as decisions for full review. The adverse event/unanticipated problem form is also shared for reporting purposes, if appropriate.

Exempt Research

The TDMHSAS-IRB Chairperson or designee may exempt a study from full or expedited review.  Research qualifying for exemption includes research as described in 45 CFR § 46.104, and at the discretion of the IRB Chair or designee.