SOP #27 Initial Review

IRB humansubjectsresearch research

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 27
Effective Date: 10/8/2021

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the courses of action the CSS IRB may take when reviewing and approving research involving human subjects.

Policy

As a result of its review of the research application, the IRB may take any of the following courses of action including:

To approve the proposed research activity;
Require modifications (specified changes to the proposed research);
To defer the action;
To table the action;
To disapprove the proposed research activity;
To acknowledge receipt of non-material changes to previously approved research; or 7) Conduct Limited Review for activities under 45 CFR 46.104 (Exempt Research).

Definitions

Full Board Review Review of proposed research at a convened Full IRB meeting at which a majority of the membership of the IRB is in attendance, including at least one member whose primary concerns are in non-scientific areas. For the research to be approved, it must receive the approval of a majority of those members attending the meeting.

Material Change A modification to the research-related documentation that alters the conduct of the research or the assessment of the risks and benefits of the study. Non-material changes (e.g. staff changes) do not require IRB review or approval.

Review Using Expedited Procedures Review of proposed research by the Chair or designee. The designee must be an experienced IRB member/alternate. (See also, CSS IRB SOP # 11 Expedited Review)

Effective Approval Date The date of confirmation that all of the IRB’s requested clarifications and modifications have been satisfactorily completed and that all ancillary approvals or other conditions for approval (e.g., evidence of FDA approval, etc.) have been met.

Human Subjects Research Research involving human subjects. (See also, CSS IRB SOP # 07 Determination of Human Subject Research)

Institutional Official The individuals identified on the Federalwide Assurance with OHRP as authorized leaders of The College of St. Scholastica’s human subjects protection program, the CSS President and VPAA.

Submission Requirements

PIs must submit a completed Application for Approval of Research with Human Subjects with each new study proposal, available at IRBNet.

The application requires descriptions of:

The subject population and that selection of subjects is equitable;
The recruitment process;
The Informed Consent process including permission from the legally authorized representative if applicable;
The research design and procedures as they affect human subjects;
Risks to subjects in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result;
How risks to subjects are minimized (See, CSS IRB SOP #13 IRB Determination of Minimal Risk.);
Precautions taken to safeguard the subjects’ welfare;
Methods to be used to protect data confidentiality and subject privacy;
Whether any inducements (e.g., cash, gift card) will be used;
Whether deception will be used (See, CSS IRB SOP #14 Deception in Research w/Sample Debriefing Scripts.);
What to do / whom to contact in case of injury; ● Other information as requested by the IRB;
Other information as governed by funding sources.

The application requires copies of:

Current (i.e., within 3 years) CITI training certificates of the PI and all research personnel;
All recruitment materials (e.g., text of an email, copy of flyer to be displayed on campus);
All consent/assent/permission forms to be used;
All surveys/scales/questionnaires/questions to be administered;
All stimuli to be presented to subjects (e.g., in words and figures/images);
Description/copies of all instruments to be used (e.g., in words and figures/images);
Debriefing statements, where appropriate;
Other materials as requested by the IRB;
Other materials as governed by funding sources (e.g., FDA documentation).

The IRB acts on all applications within one month after submission. The IRB notifies investigators in writing of board’s decisions within one week of board action. Decisions to disapprove are accompanied by reasons for the decision.

Determinations Procedure

Except when expedited review procedures are used, decisions will be based upon a simple majority of the members and alternates participating in the IRB meeting. The IRB may make one of the following determinations as a result of its review:

Approval – (Convened IRB and Expedited Review) The protocol and accompanying documents are approved as submitted. IRB approval indicates that the IRB (or IRB expedited reviewer(s)) has concluded that the application (including the research plan and consent forms) meets the federal criteria for approval. IRB approval verifies that the IRB agrees with the assessment of the protocol and/or specific findings as described by the PI in the application. The investigator will receive an approval letter documenting the IRB decision. IRB approval will commence on the day the study is approved by an action of the convened IRB or IRB Chair or designee and expire within a defined time period based on risk assessment and regulations. Approvals are always conditional. If specific conditions are stipulated in the approval letter, those conditions must be met by the designated date or approval may be withdrawn. (See also, CSS IRB SOP # 12 Criteria for Approval of IRB Research.)
Modifications Required - (Convened IRB and Expedited Review) ) IRB conditional approval indicates that the IRB (or IRB expedited reviewer(s)) has approved the protocol pending submission of minor modifications and that the IRB has given the IRB Chair (in the case of convened full review) or designee the authority to approve the minor modifications which do not involve substantive issues. At the discretion of the IRB, additional conditions for approval may be imposed. These may include third party verification of information including auditing of study records or observation of the consent process to provide additional protection for subjects. The criteria used to determine whether third-party verification is required may include:
- Studies that involve a potential high risk to subjects;
- Studies that involve vulnerable populations, particularly those studies that are greater than minimal risk;
- Studies that involve enrollment of a large number of subjects; ▪ The IRB’s previous experience with the investigator or sponsor, and;
- Studies selected at the discretion of the IRB.

The IRB chair sends the investigator a letter describing the modifications requested by theIRB. The PI responds to modifications requested by the IRB and sends the response to the IRB. The Chair or designee may forward the responses to the entire IRB for additional review (return to the convened Board), request additional information from the investigator, or approve the response.

Tabled - (Convened IRB only ) Significant questions are raised by the proposal requiring its reconsideration after additional information is received from the Sponsor and/or Investigator. A vote of tabled or deferred indicates that the IRB withholds approval pending submission of major revisions/additional information. The IRB chair sends the investigator a letter listing the reasons for tabling and includes a description of the revisions or clarifications requested. For some studies, the IRB may request that the IRB chair discuss the reasons with the investigator. The proposal is assigned for review at a specific, future meeting.
Deferred - (Convened IRB only ) Significant questions are raised by the proposal requiring its reconsideration after additional information is received from the Sponsor and/or Investigator. The proposal is postponed to an unspecified future meeting.
Disapproval - (Convened IRB only) A majority vote to disapprove research indicates that the IRB will not allow the research to be conducted. Disapproval of a protocol usually occurs when the IRB determines that the risk of the procedures outweighs any benefit to be gained or if the proposed research does not meet the federal criteria for IRB approval. Disapproval generally indicates that even with major revisions to the application the issues preventing approval will not be resolved. [Examples: part or all of the research is prohibited by a law, regulation or institutional policy; there is insufficient preliminary research to justify the proposed study; there is insufficient expertise or resources locally to safely conduct the study; the nature of the research will adversely affect the rights or welfare of the subjects]. The IRB chair sends the investigator a letter describing the reasons for disapproving the protocol. Investigator responses to the IRB decision to disapprove research are reviewed at a subsequent convened meeting of the IRB.

Notification of IRB Determinations

Documentation regarding the IRB’s determinations will be provided to the Investigator. Electronic copies of IRB meeting minutes will be available to the President of CSS and the VPAA as the Institutional Officials (IO) by request. The President and the VPAA will be notified of any suspensions, terminations, serious or continuing non-compliance, or unanticipated problems involving risks to subjects or others. (See also, CSS IRB SOP # 24, Unanticipated Problems / Adverse Event Reporting; CSS IRB SOP # 31, Suspension or Termination of IRB Approval; and CSS IRB SOP # 30, Non-Compliance with Human Subjects Research Policies.)

Length of Approval

For studies approved or conditionally approved by the IRB, the IRB determines the length of approval as appropriate to the degree of risk, but not longer than one year from the meeting date that the study was approved or conditionally approved, unless as noted below:

Non-FDA regulated research eligible for expedited review do not require a length of approvalunless the IRB determines and provides a justification for the requirement of continuing review. For research that does not require IRB continuing review, an institutional expiration date will be set per Institutional Review Policy.
The IRB may set a shorter approval period for: 1) high risk protocols; 2) protocols with highrisk/low potential benefit ratios; 3) studies involving the first use of an experimental drug or device in humans where safety data is limited; 4) studies involving research procedures not normally reviewed by the IRB; or 5) any other study the Board determines a shorter approval period and the resultant continuing review are appropriate.
The date of the meeting (convened IRB review) or date of determination (expedited IRBreview) becomes the first day (start) of the approval period with the expiration date being the first date that the protocol is no longer approved. However, studies conditionally approved by the IRB may not begin until the IRB’s conditions of approval (revisions) are approved by the designated IRB reviewer (final approval).
If the research is approved for one year, the expiration date is determined to be the same dateone year from the date which the IRB (or IRB expedited Reviewer) approved the protocol or conditionally approved the protocol. For example: the IRB reviews and approves a protocol without any conditions or approves a protocol with minor conditions for one year at a convened meeting on October 1, 2002. September 30, 2003 is the last day that research may be conducted under this approval. October 1, 2003 is the first day that the study approval is expired.
The expiration date is the first day that research is not approved and must stop unless thestudy has been re-approved (See, CSS IRB SOP # 20, Continuing Review of Approved Research).
For studies that are tabled/deferred due to substantive issues identified during the review atone convened meeting and subsequently reviewed and approved by another convened meeting, the approval period starts with the date of the subsequent convened IRB meeting.

Appeals

If the PI has concerns regarding the IRB decision/recommendations for changes in the study, he/she may submit his/her justification for changing the IRB decision to the IRB Chair for final resolution. If the investigator is still dissatisfied with the IRB decision, the IRB chair will send the protocol appeal to the convened IRB for review.