IRB Procedures

The first step in the IRB review process is for all submissions to undergo a Regulatory Review, where the IRB performs the following steps:

1. Verify Completeness: Review the submission to confirm all required materials are provided by the Investigator. Then the IRB verifies the completeness and appropriateness of the application, proposal, consent forms, training documentation, site letters, translations, subject-facing materials, and any other relevant documents provided for review.
2. Identify Regulatory Requirements: Identify and document all applicable local, state, or international regulatory requirements that must be considered for the submission. This ensures compliance with specific determinations such as waivers, the involvement of vulnerable populations, and use of medical devices, etc.
3. Level of Risk and Review: Evaluate risk to participants and determine the likely level of review (Exempt, Expedited, Full Board, 118, or Non-Engaged) based on the submission's content and associated risks.
4. Review of New Information: When new information is provided, follow the above steps, and additionally review the new documentation/information to assess if it involves updates related to new funding, financial conflicts of interest, increased or new risks, protocol deviations, unexpected harm related to research, compliance issues, breaches of confidentiality, informed consent issues, or external reports. The IRB then assesses the impact of this new information on the study and participant safety, determining if it involves an Unanticipated Problem (UP), increased risk, or noncompliance.
5. Consult Expertise as Needed: When the IRB lacks the necessary expertise for the review, it seeks external consultation to resolve review requirements and manage study team responses. This may involve consulting with experts in the relevant field or involving licensed mental health professionals for studies dealing with sensitive topics.
6. Document Findings: Document findings for the Chair and/or DIEC to review. Then the submission is assigned to a Designated Reviewer for a Non-Convened Review or Committee Review. If Committee Review is required, the Designated Reviewer and Chair collaborate to ensure issues raised during the Regulatory Review are addressed in advance of or at the meeting.

The second step in the IRB review process is the assignment of a designated reviewer which entails:

• Conflict of Interest (COI): Ensuring the reviewer has no conflicts of interest that could affect their objectivity. If a COI is identified, the reviewer must notify the Chair and DIEC to establish reassignment.
• Review Expertise: Verifying the reviewer has the necessary expertise to conduct the review effectively. The DIEC and Chair are always available to assist reviewers with questions related to regulations and specific sponsor requirements. If the reviewer has concerns of lacking the required expertise, they should request reassignment from the Chair and DIEC. Sufficient expertise includes:
  • Relevant Knowledge: Possessing the necessary ethical, scientific, and scholarly knowledge pertinent to the study’s research area to accurately assess the study's design, methodology, and potential impact on participants.
  • Experience with Populations: Having knowledge of or experience with the target population, particularly if the research involves vulnerable populations and is funded by an entity with specific requirements for including these populations.
  • FDA-Regulated Test Articles: Being knowledgeable about FDA regulations and their implications for study design and participant safety if the research involves FDA-regulated test articles.
  • Federal Agency Requirements: Understanding the specific requirements and regulations associated with federal agencies (e.g., DOD, DOE, DOJ, ED, EPA, NIH) if the research is sponsored by these agencies.
  • Community-Based Participatory Research: Familiarity with community-based participatory research methods and their ethical considerations if the study employs these approaches.
  • Prisoner Research: Qualification as a prisoner representative or expertise in ethical considerations related to research with incarcerated individuals if the study involves prisoner research.
  • International Research: Knowledge of the relevant country’s regulations, cultural context, and ethical standards if the research is conducted internationally.

The Designated Reviewer is responsible for reviewing each submission to ensure:

• Completeness: The protocol explicitly outlines the design and procedures from inception to completion.
• Minimization of Risks: Risks to subjects are minimized:
  • By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
  • Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
• Risk-Benefit Ratio: The risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The reviewer should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy).
• Equitable Selection of Subjects: The selection of subjects must be equitable and conducted in a manner that is fair and just. Ethical considerations include:
  • Ensuring the research does not disproportionately burden or exclude specific groups, particularly vulnerable or marginalized populations, unless justified by the research objectives. The benefits of the research should be distributed fairly among all potential subjects.
  • Ensuring the recruitment process does not exploit vulnerable populations or individuals in a disadvantaged position. Avoid selecting subjects based on their ease of access or likelihood to consent without regard for their situation.
  • Guaranteeing all subjects are able to make an informed and voluntary decision about their participation. Recruitment strategies should facilitate understanding of the research, its risks and benefits, and ensure subjects are not subjected to coercion or undue influence.
  • When appropriate, aim for a diverse and representative sample to enhance the generalizability of the research findings and reflect a range of experiences and characteristics relevant to the study.
• Protection of Vulnerable Subjects: When subjects are considered part of a vulnerable population, additional safeguards must be integrated into the study to protect their rights and welfare, which includes ensuring that:
  • The research design incorporates specific protections to address the vulnerabilities of the population involved.
  • Consent processes are adapted to accommodate the needs and circumstances of vulnerable subjects.
  • The study includes mechanisms for monitoring and responding to any adverse effects or signs of coercion.
• Informed Consent: Each subject or their legally authorized representative must provide informed consent as required. Ensuring:
  • The consent process is comprehensive and includes all necessary information about the study's purpose, procedures, risks, benefits, and alternatives.
  • Consent is appropriately documented, or an appropriate waiver is requested and justified.
  • The consent process is conducted in a language and at a literacy level that the subject can understand, and that subjects have adequate time to consider their participation.
• Deception or Withholding of Information:If deception or withholding of information is necessary for adequate testing of the hypotheses and there is no practical alternative:
  • Sufficient justification is provided that the potential benefits to the subject or the importance of the knowledge to be gained outweigh any potential risks that may be present as a result of such deception.
  • Assurance of an acceptable debriefing process is in place to provide subjects with a full explanation of the deception and its purpose, as well as any potential effects or risks resulting from participation. If the research design includes deception, ensure that:
    • The debriefing occurs as soon as possible after participation, or at a time deemed appropriate by the IRB if immediate debriefing could affect data collection.
    • If the deception might cause emotional distress, the debriefing must be thorough and timely, addressing any concerns or questions the subjects might have.
  • Adequate Facilities and Resources: The facilities and resources necessary for the protection of subjects’ rights and the completion of the study are adequate, which includes:
    • Evaluating the physical, technological, and personnel resources available to ensure they meet the study's needs.
    • Confirming the facilities are safe and conducive to the study's conduct.
    • Ensuring there are contingency plans for emergencies or unexpected issues that may arise during the study.
  • Data Monitoring: There are robust provisions for data monitoring to protect subject safety. This includes:
    • Implementing a data monitoring plan that specifies how data will be reviewed and analyzed to ensure ongoing participant safety.
    • Establish criteria for halting the study if interim findings indicate unexpected risks or adverse effects.
    • Appointing a data monitoring committee or individual, if required, to oversee data collection and analyze interim data to ensure subjects’ safety and welfare.
  • Privacy and Confidentiality: Adequate measures are in place to protect subject privacy and maintain data confidentiality, which includes:
    • Implementing secure data storage and handling procedures to prevent unauthorized access or disclosure of personal information.
    • Ensuring that data is de-identified or anonymized as appropriate and that any identifiers are kept secure.
    • Informing subjects of how their data will be used, stored, and shared, and obtaining consent for any use beyond the scope of the initial study.

At the review's completion, the designated reviewer documents findings via notes for the Chair and/or DIEC.

The Non-Convened Review procedure begins when the Chair or DIEC determines the submission may be reviewed and approved via a Non-Convened Review. Once the Designated Reviewer completes the review, the IRB may proceed as follows:   

If not specifically Human Subjects Research, the reviewer will make one of these determinations:

• “Not Human Research”: The reviewer determines the submission does not meet the definition of Human Research. Notify the Chair and DIEC of the review.
• “Human Research Not Engaged”: The reviewer determines the submission meets the definition of Human Research but does not engage the institution.
• “Additional Information Necessary”: The reviewer determines the review requires additional information to be provided to assess if the human subject’s research is being conducted. The reviewer’s documented notes outline a list of concerns which must be addressed before a determination can be made.

If the submission involves Human Subject Research per OHRP definition, then take one of the following actions:

• “Requires Revisions”: The submission requires revisions before it can be granted the action of “Approve.” The reviewer’s documented notes outline a list of concerns which must be addressed via revision/modifications, or a justification/clarification must be provided before approval can be issued. This action requires the resubmission to be re-reviewed by the assigned Designated Reviewer, DIEC, or Chair.
• “Return/Deny”: The submission does not meet the criteria for approval and the submission is found to have extensive deficiencies. The reviewer’s documented notes include a list of concerns which must be addressed via required revisions/modifications and/or justification/clarification. This action requires the resubmission be re-reviewed by the assigned Designated Reviewer, DIEC, or Chair.
• “Approve”: The submission meets the criteria for approval.

If exempt, designate the corresponding review category and confirm:

• The research is not FDA-regulated.
• The research does not involve nor interact with Prisoners, nor is conducted or funded by DHHS, Dept. of Defense (DOD), and is NOT aimed at involving a broader subject population that only incidentally includes prisoners.
• The research is not classified nor conducted or funded by the Department of Energy (DOE).
• The research presents no more than Minimal Risk to subjects.
• The selection of subjects is equitable, the research is appropriate for the population being studied.
• If the research involves interactions with subjects, standard requirements for informed consent are met, or an appropriate waiver is requested.
• The research does not involve 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.

If expedited review, designate the corresponding review category and confirm:

• The research is not classified.
• The research presents no more than Minimal Risk to subjects.
• If prisoners are involved, the prisoner representative reviewed the submission and concurs with determination.
• The research does not involve the identification of subjects and/or their responses in a manner that would reasonably place them at risk of criminal or civil liability, damage their financial standing, employability, insurability, or reputation, or cause stigmatization unless reasonable and appropriate protections are implemented to ensure that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
• The standard requirements for informed consent are met, or an appropriate waiver is requested.
• If the submission involves a modification, this does not affect the design of the research nor add more than minimal risk to the subjects.
• “Committee Review”: The reviewer determines the submission warrants review Full Board.

If new information is provided for review, take one of the following actions:

• “Accept/Acknowledge”: The reviewer examines the new information provided by the study team and determines that no further action or additional information is required. This means the IRB accepts the documentation and considers the matter resolved without the need for further review or action.
• “Request Additional Information/Modifications”: The reviewer examines the new information provided by the study team and determines further information is required before the review can proceed. The reviewer’s documented notes include a list of concerns which must be addressed via required revisions/modifications and/or justification/clarification. This action requires the resubmission to be re-reviewed by the assigned Designated Reviewer, DIEC, or Chair.
• “Rescind Approval”: A prior approval of a document, site, investigator, and so forth was incorrectly provided by the PI and therefore approval is rescinded. The research may not continue once approval is rescinded. The reviewer’s documented notes include a list of concerns which must be addressed via required revisions/modifications and/or justification/clarification. This action requires the resubmission be reviewed by the assigned Designated Reviewer, DIEC, or Chair.
• “Committee Review”: The reviewer determines the submission warrants review Full Board.

Meeting Review Procedure

During a Committee Review, the Designated Reviewer leads the discussion in collaboration with the Meeting Chair and IRB members who collectively share the responsibility of:

• Having the appropriate expertise to discuss scientific/scholarly review.
• Reviewing all submitted materials for consistency, reviewing the findings/concerns identified via the Regulatory Review, and identifying any additional findings/concerns or information is necessary to answer questions about the submitted materials.
• Assessing if the criteria of approval are met. If one or more criteria are not met, consider what specific and directive changes would make the protocol approvable.
• For reviews related to an Unanticipated Problem Involving Risks to Researchers or Others, Serious Noncompliance, Continuing Noncompliance, Suspension of IRB Approval, Termination of IRB Approval, or new information is provided, determine whether additional information is necessary, or if the submission, approval interval, corrective action plan, or monitoring plan requires modification.
• Summarizing the IRB’s consensus and providing notes to the DIEC for the generation of minutes and correspondence.

Meeting Vote

During meetings, the Meeting Chair and DIEC ensure:

• All members who are part of the quorum vote. If the quorum is lost, ensure no further action is taken until quorum is restored.
• Notes and/or concerns from absent members are included in discussions, though absent members may not vote.
• To determine the voting status of alternate members, ensure the number of voting members does not exceed the number of regular members on the IRB roster.
• If a guest/observer attends, ensure they do not participate in deliberations, unless requested to serve as a consultant. Guests/observers can participate in the vote and must agree to maintain confidentiality of the IRB proceedings.
• After sufficient discussion of each agenda item, call for a vote from IRB members present at Committee Review as “For,” “Against,” or “Abstaining” in the motion for:

• • “Approval”: The research meets the criteria for approval and more than 50% of the quorum votes in favor of protocol approval. For initial and continuing review, include in the motion, the level of risk (minimal risk or greater than minimal risk), and either that continuing review is not required, or the period of continuing review.
  • “Requires Revisions”: The research will meet the criteria for approval with minor prescriptive changes or requirements that can be verified without considering the criteria for approval. Summarize the IRB required modifications and reasons. For initial and continuing review, include in the motion, the level of risk (minimal risk or greater than minimal risk), and either that continuing review is not required, or the period of continuing review. If the protocol is ambiguous, request to obtain written information from the sponsor or investigator
  • “Table”: Further information is necessary to supplement the initial, continuing, or modification submission to meet the criteria for approval and requires re-review by the Committee Review. Summarize the IRB reasons for motion and detail information Review of submissions may also be tabled when a quorum is lost. A tie vote for and against “Approval” / “Conditional Approval” also results in the tabling of a registration review.
  • “Return/Deny”: When the initial, continuing, or modification submission does not meet the criteria for approval and the IRB considers the research to have extensive deficiencies. Summarize the IRB reasons for the motion and detail all information required to meet the criteria.
  • “Suspend”: Based on new information, the previously approved research no longer meets the criteria for approval, or when only some research activities meet the criteria for approval, or when the IRB has revision recommendations to make the research meet the criteria for approval. Summarize the IRB reasons and/or recommendation for the motion, including which research activities must stop or be modified, and detail all information required to meet criteria. The IRB may lift suspension when resubmission addresses concern and meets the criteria of approval via Non-Convened Review.
  • “Terminate”: When the IRB determines that based on new information the previously approved research no longer meets the criteria for approval and the IRB has no recommendations to make the research approvable. Summarize the IRB reasons for the motion.

The DIEC is responsible for administrative oversight of the IRB review process. The DIEC schedules meetings, creates the meeting agenda, disseminates submission documents, and relevant meeting materials electronically, records minutes and then distributes minutes for IRB members to review.

Schedule: The IRB meets monthly. If there are no submissions which require Committee Review, the meeting is then cancelled 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.

Agenda: The agenda is provided to IRB members electronically in advance of 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 the submissions issued as approved, require revisions, and have been withdrawn via Non
• Convened Designated Review since last meeting.
• Previous Committee Review meeting minutes for review and approval.
• Administrative updates relating to IRB announcements and/or educational materials.

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 quorum requirements.
• The IRB has 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 documenting agreement of the consultant to maintain confidentiality of information provided, prior to Committee Review invitation. If the consultant provides a written report, provide the report to the IRB members for review.

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 members 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 Chair prior to distribution. 

Post Review

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 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.

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.

IRB Follow Up

• Check in with investigators who have not resubmitted within 14 days of 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

Consultant Review

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 is 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 IRB meeting by the consultant or IRB Chair.

IRB Record Requirements

A. Documentation of IRB Activities

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

1. Research Proposals and Consent Documents:
   • Copies of all research proposals reviewed.
   • Approved sample consent documents.
   • Continuing reports submitted by investigators.
2. 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).
3. 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.
4. Correspondence:
   • Copies of all correspondence between the IRB and the investigators.
5. Significant New Findings:
   • Any statements of significant new findings (unanticipated risks or adverse reactions) were provided to subjects.
6. Adverse Reactions Reports:
   • Adverse reactions reports and documentation that the IRB reviews such reports.
7. Emergency Use Reports:
   • Emergency use reports.
8. 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.

B. 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.