IRB Administrative Procedures

The DIEC is responsible for administrative oversight of the IRB administrative processes. 

 Meeting Preparation: As a part of meeting preparation, the DIEC ensures:

  • All attendees are provided with or have access to the materials at least one week before meetings.
  • Each agenda item has a reviewer, and Designated Reviewers are prepared to present assignments.
  • IRB members (regular, alternate, IRB chairs) confirm availability to be present at the meeting and that the meeting quorum will be appropriately met. If the meeting will not meet the quorum requirements, make arrangements to meet the quorum requirements.
  • The IRB has the appropriate expertise to review submissions listed on the agenda. If the IRB does not have the relevant expertise available, a consultation may be requested from university employees or external consultants. If a consultant is requested, ensure to determine if there is a Conflict of Interest. Ensure the documentation agreement of the consultant to maintain the confidentiality of information provided, before the Committee Review invitation. If the consultant provides a written report, provide the report to the IRB members for review.

Agenda: The agenda is provided to IRB members electronically in advance of the meeting and includes:

    • New Protocols, Renewals, Modifications, or New Information submissions.
    • All relevant submission documents and designated reviewer pre-review notes.
    • Identifies Conflicts of Interest.
    • Lists of the submissions issued as approved, require revisions and have been withdrawn via Non-Convened Designated Review since the last meeting.
    • Previous Committee Review meeting minutes for review and approval.
    • Administrative updates relating to IRB announcements and/or educational materials.

Minutes: Meeting minutes are drafted and distributed to all IRB members by DIEC before the next meeting for review and approval. Committee Review minutes include the meeting date, time of start and finish, attendance, conflicts of interest, and discussion of agenda items. The minutes section of each registration includes information on:

  • Submission Information: Lists the IRB Number, Project Title, PI, Sponsor Name, Grant Number, Review Category, Designated Reviewer, Vulnerable Populations, Level of Risk, and Basis for Level of Risk.
  • Discussion Summary: Includes a brief discussion summary, including mention of any previous actions, consultation reports, and controverted issues or concerns relating to the submission are identified with proposed resolutions.
  • Determinations: Include all applicable determinations (waivers; subparts b, c, d; devices; etc).
  • Motion: Each motion requires specific information to be captured:
    • For a motion of “Approval,” no other information needs to be recorded.
    • For a motion of “Requires Revisions” related to an initial or continuing review submission records the reasons and required modifications.
    • For a motion of “Table” and “Return/Deny” record the IRB’s reasons and recommendations.
    • For a motion of “Suspend” record the specific activities suspended, reason for suspension, and the IRB’s recommendations, if any.
    • For a motion of “Lift Suspension,” no other information needs to be recorded.
    • For a motion of “Terminate” record the IRB’s reasons.
  • Vote: Each vote must be captured for each voting member vote as:
    • “For”: Voting for the motion.
    • “Against”: Voting against the motion
    • “Abstain”: Present for the vote, but not voting “For” or “Against”
    • “Absent”: Present for the meeting but not present for the vote.
    • “Recused”: Present for the meeting but not present for discussion and vote due to a Conflicting Interest.
  • Correspondence: Drafting all IRB correspondence (approval letters, notices, post-review requests for revisions, and acceptance memos) for review and approval by the Chair before distribution.

Schedule: The IRB meets monthly. If there are no submissions that require Committee Review, the meeting is then canceled by the Chair or DIEC. If there is a time-sensitive matter which requires Committee Review, submissions with specific funding timelines, noncompliance or serious and/or unexpected events/problems, an emergency ad hoc meeting can be called to order by the Chair or DIEC, as necessary. Meetings may be conducted by teleconferencing and a written record of the meeting is created by the DIEC to document committee actions and requirements.

The post-review process begins when a Designated Reviewer or Committee Review determines whether a submission requires revision to secure approval or cannot be approved.   

Communication of Findings and Actions:

  • The IRB communicates its findings and actions to the investigator.
  • The IRB reports its findings and actions to the institution as required.
  • When the IRB disapproves of research, it provides the investigator with a statement of the reasons for the decision and offers the opportunity to respond in person or in writing.

Timeliness of Communications:

  • Communication of review results to investigators is completed within 7 business days of the IRB meeting or receipt of completed review.
  • Reporting of Serious Non-Compliance, Continuing Non-Compliance, Suspension of IRB Approval, Termination of IRB Approval, and Unanticipated Problems Involving Risks to Subjects or Others to outside agencies, as applicable, must occur within 30 days of the determination of a reportable event.

The appeal of IRB Decisions:

  • If an investigator disagrees with an IRB decision, they may submit a written appeal to the IRB Chair or DIEC within 30 days of receiving notification of the decision.
    • The appeal should include information supporting the disagreement.
    • For appeals involving research reviewed by a Designated Reviewer, the appeal is reviewed by the Designated Reviewer, IRB Chair, and DIEC.
    • For appeals involving research reviewed by the convened board, the appeal is reviewed by the convened board. The investigator may request to address the board to provide clarification or additional information.
    • The investigator will be notified in writing of the decision.
  • The IO may override the IRB’s decision to approve research; however, the IO or institution cannot approve research that has not been approved by the IRB or overrule other IRB decisions.
  • Check-in with investigators who have not resubmitted within 14 days of a request for revisions.
  • Remind investigators whose study is exempt within 30 days of the anniversary of approval that their study will continue to be considered open unless a closure report is submitted.
  • Remind investigators whose study is non-exempt within 30 days of the expiration that their study will require a continuing review application.
  • Notify investigators whose approval has lapsed due to lack of continuing review.
  • When possible, contact the investigator to determine if enrolled subjects should continue in the research because it is in their best interest.
  • Inform the investigator:
    • Which subjects may continue.
    • What procedures may continue.
    • All other research activities must stop, including advertisement, recruitment, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.
    • New subjects may not be enrolled.
    • The continuing review progress report must be submitted as soon as possible.

The IRB utilizes consultants to enhance IRB reviews when a project requires specialized expertise beyond the scope of IRB membership. Consultants may be needed for:

  • Expertise related to a particular intervention or procedure.
  • Understanding of the characteristics of a research population, including customs, social mores, or religious beliefs.
  • Knowledge of the scientific or scholarly validity specific to the research design.
  • Experience related to a research site or international locale, including local laws.
  • Expertise related to protecting participants, including informed consent, privacy, and data confidentiality.

During the initial review of a submission, if the Designated Reviewer identifies the need for additional expertise is needed to complete the review, the designated reviewer must notify the DIEC or IRB Chair. Once identified, the DIEC, IRB Chair, or IO will consult with IRB members, University, affiliate administrators, or faculty to identify suitable experts.

The convened IRB may also determine that additional expertise is required:

  • If the IRB decides that additional expertise is necessary before approval, the review and approval are deferred until the consultant’s review is completed and presented at a subsequent meeting.
  • If the IRB approves the submission with conditions but deems consultation necessary for finalizing changes, the consultant will work with the Designated Reviewer and DIEC to confirm the necessary information from the PI.

Consultants are not appointed members of the IRB and do not have voting rights. Their role is limited to providing expertise for specific submissions. Once an appropriate consultant is identified, the DIEC ensures:

  • The consultant has no conflicts of interest that might affect the review before engaging in the review process. Consultants with conflicts may only participate under these conditions:
    • They restrict their input to the information requested by the IRB, or
    • They disclose their conflict to the IRB before presenting their comments if no alternative expert is available.
  • Consultants receive relevant materials and must provide written comments and recommendations. These documents are attached as the agenda.
  • Consultant reviews, summaries, findings, considerations, and recommendations are presented to the Designated Reviewer via email or at an IRB meeting by the consultant or IRB Chair.

The IRB prepares and maintains adequate documentation of IRB activities within the Office of Research Administration, including the following:

  1. Research Proposals and Consent Documents:
    • Copies of all research proposals reviewed.
    • Approved sample consent documents.
    • Continuing reports submitted by investigators.
  1. Minutes of IRB Meetings:
    • Members present (any consultants/guests/others shown separately).
    • Results of discussions on debated issues and record of IRB decisions.
    • Record of voting (showing votes for, against, and abstentions).
  1. Continuing Review Activities:
    • Records of continuing review activities.
    • Updated consent documents and summaries of ongoing project activities.
    • Consent documents are stamped to show IRB approval and date of approval expiration.
  1. Correspondence:
    • Copies of all correspondence between the IRB and the investigators.
  1. Significant New Findings:
    • Any statements of significant new findings (unanticipated risks or adverse reactions) were provided to subjects.
  1. Adverse Reactions Reports:
    • Adverse reactions reports and documentation that the IRB reviews such reports.
  1. Emergency Use Reports:
    • Emergency use reports.
  1. General Project Information:
    • General project information provided to subjects (e.g., fact sheets, brochures).

Retention and Accessibility of Records

These documents and records shall be retained for at least three (3) years after the research is completed. The records shall be accessible for inspection and copying by authorized representatives of the Department of Health and Human Services, the Food and Drug Administration, the Department of Veterans Affairs, and other federal regulatory agencies, at reasonable times and in a reasonable manner.

Preservation of Informed Consent Forms

All forms submitted or retained as evidence of informed consent must be preserved by the investigator indefinitely. Should the Principal Investigator (PI) leave UMassD, signed consent forms are to be transferred to the DIEC to be secured within the Office of Institutional Ethics & Compliance.