Engagement in Research

118 Review is used when proposals lack definite plans for human subject involvement. 

Under federal regulations (§46.118), certain grant applications are submitted without specific plans for human subjects' involvement detailed in the proposal. These situations typically fall into three categories:

• Institutional Grants: Specific projects are determined by the institution at a later stage.
• Research Training Grants: Activities involving human subjects are yet to be selected.
• Projects Dependent on Preliminary Work: Human subjects' participation depends on the development of instruments, completion of prior animal studies, or purification of compounds.

Process for 118 Proposal Review:

• Submission: Principal Investigators (PIs) should submit their proposals to the IRB when applying for grants that fall under §46.118. Submissions should occur at the grant application stage, prior to the selection or development of specific human subject activities.
• Assessment: The IRB will review the proposal to assess whether the project involves human subjects at its current stage. The review will determine if the application meets the criteria for §46.118 and if it can be approved as lacking definite plans for human subjects' involvement.
• Outcome: If the preliminary proposal is acceptable under §46.118, the IRB will issue a determination to satisfy federal sponsor requirements, such as Just-In-Time submissions, allowing access to funding for aspects of the project not involving human subjects.
• Conditions: The initiation of any human subject research activities is strictly contingent upon the completion and approval of a full application. This includes submission of all required materials (e.g., recruitment materials, consent forms, surveys, research tools, etc.) and obtaining IRB approval in accordance with §46.111.

When the 118 Determination is Not Acceptable:

If the IRB determines that the proposal does not meet the criteria under §46.118:

• The PI will be notified and must provide additional details or modifications to address the IRB's concerns.
• The project cannot proceed with human subject activities until these requirements are met and full IRB approval is obtained.
• The IRB will provide guidance on what is needed to make the proposal acceptable.

PIs should anticipate this process and submit their proposals as early as possible to ensure timely review and determination. This allows for necessary adjustments and avoids delays in accessing grant funds or commencing human subjects research.

The term “exempt” is frequently mistakenly interpreted as not requiring IRB review. However, exempt human subjects research still necessitates an IRB determination of exempt status. Researchers are not authorized to independently determine if their study qualifies for exemption; such exemption determinations are issued by the IRB. Furthermore, it's important to note that exempt status does not exempt research from ethical considerations or regulatory requirements. Studies meeting the exemption criteria must still undergo IRB for review before commencing the research as well as report enrollment status to the IRB annually. For a full list of exemption categories, see Resource: Appendix – Exemption Categories. 

Criteria for Exemption:

To qualify for exempt status, research activities must meet specific criteria as outlined in federal regulations (45 CFR 46):

• Minimal Risk: The research presents minimal risk to participants, meaning that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.
• Specific Categories: The research falls into one or more categories specified in the federal regulations as eligible for exemption. These categories typically include research involving existing data, documents, records, or specimens; certain educational practices; anonymous surveys or interviews; and certain types of public observation.
• Protection of Privacy and Confidentiality: Adequate measures are in place to protect the privacy and confidentiality of participants and their data.
• Voluntary Participation: Participation in the research is voluntary, and participants provide informed consent when required, ensuring they are fully aware of the nature and purpose of the study before deciding to participate.

Process for Exempt Review:

• Submission: Researchers seeking an exempt determination must complete and submit an IRB application along with the proposal, consent documents, site letters, subject-facing materials (e.g., recruitment flyers/emails, questionnaires, survey documents), and any other relevant attachments. These materials should be submitted via email toresearch@umassd.edu for review and approval.
• Review: Exempt reviews are conducted by designated IRB members who focus on confirming that the research meets the exemption criteria and ensuring appropriate protections are in place for participants.
• Outcome: If the study qualifies for exemption, the IRB will issue an exempt determination. Studies receiving this determination do not receive an expiration date and do not require continuing review. However, PIs are responsible for notifying the IRB annually of the study's enrollment status.

Studies which receive exemption determinations must only submit amendments when:

• Adding procedures that could alter risks to participants; or
• Adding procedures outside the approved exemption categories; or
• Involving new types of participants, especially vulnerable populations (e.g., adding children, individuals with cognitive impairments, prisoners, pregnant women, etc.) or
• Changing the Principal Investigator.

Examples of modifications that would likely require IRB review:

• Changes to the data storage plan which may affect confidentiality.
• Removal of the consent process, or use of deception or incomplete disclosure.
• Significant changes to the recruitment procedures.
• Adding sensitive questions to a survey or interview process (e.g. questions regarding illegal activities; traumatic events such as childhood, sexual, or domestic abuse; suicide; or other probing questions that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation).
• Collection of new or additional identifiable information or sources.

Restrictions on Exemptions:

• Studies which are greater than minimal risk do not qualify for exemption.
• Exemptions do not apply to research with prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners. [45 CFR 46.104(b)(2)].
• Exemption 2(iii) and Exemption 3 do not apply to research with children.
• Only exemption category 6 (for taste and food quality evaluation and consumer acceptance studies) applies to studies that are FDA-regulated. Exemptions, other than Exemption Category 6, do not apply to FDA-regulated research. 

Expedited review is a streamlined process designed for specific types of non-exempt, minimal-risk research. This type of review is faster than full board review but still requires careful IRB scrutiny to ensure ethical standards are met and participant protections are in place. Research must fall into one of the seven regulated categories to qualify for expedited review. For a full list of Expedited Review Categories, see Resource Appendix: Expedited Review Categories.

Key Points for PIs:

• Eligibility:Only non-exempt, minimal-risk research qualifies for expedited review.
• Privacy and Confidentiality:Risks related to privacy and confidentiality must be minimal.
• Exemptions:Not applicable if risks related to privacy breaches or confidentiality are more than minimal.
• Common Examples:Moderate exercise studies by healthy volunteers, data analyses, linguistic studies, ethnographic studies, focus groups, non-anonymous sample collection with minimal risk.

Criteria for Expedited Review:

To qualify for expedited status, research activities must meet specific criteria as outlined in federal regulations (45 CFR 46):

1. Minimal Risk: The research presents minimal risk to participants, meaning that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.
2. Specific Categories: The research falls into one or more categories specified in the federal regulations as eligible for expedited review. These categories typically include:
• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.
• Prospective collection of biological specimens for research purposes by noninvasive means.
• Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice.
• Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes.
• Collection of data from voice, video, digital, or image recordings made for research purposes.
• Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
• Continuing review of research previously approved by the convened IRB under specific conditions.

Process for Expedited Review:

1. Submission: PIs must complete and submit an IRB application along with the proposal, consent documents, site letters, subject-facing materials (e.g., recruitment flyers/emails, questionnaires, survey documents), and any other relevant attachments. These materials should be submitted via email to irb.research@umassd.edu for review and approval.
2. Review: Expedited reviews are conducted by at least one designated IRB member who focuses on confirming that the research meets the expedited criteria and ensuring appropriate protections are in place for participants.
3. Outcome: If the study qualifies for expedited review, the IRB will issue an approval. Approved studies are valid for one year and require an annual continuing review. PIs must seek IRB approval for any changes affecting review category, risk, population, study funding, or PI. PIs who wish to continue their research projects beyond the year term should plan to submit a continuing review application before the one-year expiration date.

Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review (also referred to as Convened Review). This is the most rigorous level of review and, accordingly, is reserved for research projects that present more than minimal risks to subjects.

Common examples include:

• Greater than Minimal Risk: Research projects involving more than minimal risk
• Clinical Trials: Research projects involving clinical trials and/or clinical interventions
• Vulnerable Populations: Research involving vulnerable populations, such as children, prisoners, pregnant women, or individuals with intellectual or physical impairments/disabilities, is subject to Full Board review due to the additional protections required.
• Medical Devices: Research involving medical devices, especially if the device is FDA-regulated, often requires Full Board review.
• Sensitive Information: Research that involves the collection of sensitive information (e.g., child abuse, violence, sexual conduct/misconduct, mental health/status information, AIDS, alcohol, compulsive disorders, etc.) may require Full Board review to ensure adequate protections are in place.
• Potential Coercion: Projects that involve possible coercion or undue influence that induces or entices consent (e.g., excessive compensation, inequitable relationship, etc.)
• Deception: Research involving deception or incomplete disclosure to participants typically requires Full Board review to address ethical concerns (e.g., intentionally misleading subjects about their status, giving false information about the researchers or the research purpose).
• Significant Changes: Any notifications or significant changes to an approved greater than minimal risk study that impact risk levels, participant populations, or the study’s design must be reviewed and approved by the Full Board before implementation.

Submission Process:

PIs must complete and submit an IRB application along with the proposal, consent documents, site letters, subject-facing materials (e.g., recruitment flyers/emails, questionnaires, survey documents), training, and any other relevant attachments. These materials should be submitted via email to irb.research@umassd.edu for review and approval.

Review Process:

The ability to schedule a study for review is related to the pre-review response time needed to ascertain whether the application is complete, provide IRB members time to review these materials prior to a convened Full Board Meeting, and allow the IRB the opportunity to gather additional expertise that may be required for the review. Full Board committee meetings are held once monthly, and ad-hocs are scheduled on an as-needed basis to review applications, typically within two weeks of submission of all necessary proposal materials. The committee discusses the study and determines whether the Criteria of Approval for Human Subject Research are met and makes a decision. Within one week after the meeting, the IRB will communicate to the PI any changes requested by the committee and will work with the study team to resolve any issues. Typically, this communication will indicate one of the following:

• Approval: This letter indicates nothing else is needed and you may proceed using the protocol or other documents uploaded in the submission.
• Modifications Required: This determination is made when the IRB or designated reviewer requires specific, clear-cut modifications to the research before approval can be granted. This means that all regulatory review criteria have been met; however, additional modifications or documents must be provided for the protocol to be considered complete (for example, minor modifications to consent forms, revision of a flyer, or completion of training). Modifications may be reviewed and approved by the IRB without requiring re-review by a convened IRB.
• Steps for PIs: The PI must address concerns identified and submit the revised documents to the IRB. The IRB will review these modifications and, if satisfactory, grant final approval without requiring another full board review.
• Tabled: This determination is made when the IRB was unable to reach a determination during the specified meeting time and will discuss the proposal at a later date. This tabling may be needed if additional information is needed from the IRB applicant before review can continue.
• Returned: This determination is made when the convened IRB determines that regulatory review criteria either have not been met or that not enough information is provided to determine if these criteria have been met (for example, risks to subjects are unclear or not minimized, subject selection is not equitable, the consent process described is not approvable). When making this motion, the IRB describes its reasons for this decision, offers suggestions for revisions to address these concerns, and provides the investigator an opportunity to respond by providing additional information or justification to the IRB. Responses to a deferred protocol require review by the full committee at a convened IRB meeting.
• Steps for PIs: The PI must address the concerns identified and submit the revised documents to the IRB. The IRB will review these modifications and, if satisfactory, submit for another full board review.
• Disapproved: This determination is made when the IRB determines that it is unable to approve research because the protocol does not meet regulatory approval criteria, and the IRB also cannot describe modifications that might make the research approvable in its current state or design. When making this motion, the IRB describes its reasons for this decision and gives the investigator an opportunity to re-write and resubmit the protocol. The investigator may request to be allotted time in a convened meeting to discuss the issues with the board. The research may also be disapproved at an institutional level if it involves subject areas or procedures unacceptable to the university’s vision or mission. The Institutional Official may not approve a study if the IRB has disapproved it. Protocols that are disapproved require a full re-design and a new submission to be reconsidered by the IRB.
• Suspended: This determination is made when the IRB decides to temporarily halt the research due to concerns regarding participant safety, regulatory compliance, or other issues that need resolution.
• Terminated: This determination is made when the IRB decides to permanently halt the research due to serious noncompliance, participant safety concerns, or other significant issues.

Reliance or Facilitated reviews occur when the UMassD IRB relies upon the review of another IRB (IRB of Record), in accordance with the terms of a reliance agreement.  A facilitated review does not require a convened IRB review, rather, a facilitated review accepts and relies on the approval issued by the external IRB (either center or single IRB).   A facilitated review is conducted when an IRB agrees to rely on the review of an IRB from an external institution, via an executed IRB Authorization Agreement (IAA) or other reliance agreement. The specific details of the level of review and the criteria for review of protocols process is contingent upon the relevant Agreement.  The DIEC may act in liaison with the IRBs of other institutions as necessary to assist in the review of joint and cooperative projects involving multiple sites and/or investigators. Approvals under these categories are reported to members of the IRB that conducted the facilitated review via approved minutes. Studies that qualify for an exempt determination, do not require a reliance agreement, although consultation with the IRB office is recommended to confirm the exemption status and ensure proper documentation.

During a reliance or facilitated review process, the IRB undertakes several key steps to ensure ethical and regulatory compliance for research involving human subjects.

Process for Reliance/Facilitated Review:

2. Submission: PIs must complete and submit an IRB application along with the proposal, consent documents, site letters, subject-facing materials (e.g., recruitment flyers/emails, questionnaires, survey documents), and any other relevant attachments. These materials should be submitted via email to irb.research@umassd.edu for review and approval.
3. Evaluate the Request: The IRB reviews the request for reliance or facilitated review to ensure appropriateness, including the scope of the study and the institutions involved. This involves assessing whether the research meets the criteria for reliance or if facilitated support is needed.
4. Coordinate with External Parties: The IRB coordinates and manages communication with researchers, external reviewers, and/or consultants, as needed, to obtain additional expertise or feedback throughout the review process. Establish a clear communication plan between the relying institution and the IRB of Record to ensure all parties are informed of any updates, changes, or issues.
5. Facilitate Resolution of Issues: The IRB works to resolve any ethical or compliance issues that may emerge during the study. This may involve coordinating with other institutions, reviewing additional documentation, or making recommendations for improvements.
6. Assess and Confirm Compliance: For facilitated review, the IRB may conduct a preliminary review to identify and address major issues before the full review. For reliance, the IRB reviews documentation from the lead institution’s IRB to verify that the study has been reviewed and approved according to applicable regulations.
7. Execute Agreements: Once a reliance/facilitated review is completed, if there are no issues, and if the study qualifies for reliance, the IRB executes a reliance agreement that outlines the responsibilities and terms of reliance between institutions and specific instructions related to the review of each different type of event (e.g., new protocols, modifications, unanticipated problems, noncompliance, etc.) explained in the respective sections. Via a reliance agreement, the IRB accepts to rely on the approval issued by the external IRB, which may be a single IRB or a central IRB, in accordance with the terms of a reliance agreement.
8. Monitor and Ensure Compliance: The IRB monitors the study’s ongoing compliance with ethical standards and institutional policies, whether through direct oversight or by working with the lead IRB and local investigators in reliance scenarios to ensure terms of agreement are followed. This includes submitting amendments, continuing review, reviewing reports, and addressing any issues that arise. Approvals under reliance/facilitated reviews are reported to the IRB members via approved minutes. Maintain thorough documentation of all reliance agreements, reviews, communications, and decisions to ensure transparency and accountability.

For more information see guidance: IRB Guidance on Reliance Agreements.

• Amendments: Before implementing any changes or modifications that impact the approval category, risk, population, study funding, or PI, the PI must obtain IRB approval for the amendment(s) which:
• Add procedures that could alter risks to participants.
• Add procedures that deviate from the approved protocol.
• Involve new types of participants, especially vulnerable populations (e.g., adding children, individuals with cognitive impairments, prisoners, pregnant women, etc.). or
• Change the Principal Investigator.

• Continuing Reviews: Research approved by the IRB via expedited review, or a convened Full Board is approved for one year. The expiration date is included in the approval letters. The PI is notified 60 days prior to the expiration date that they must submit a progress report in sufficient time for the IRB to approve the continuation of human subjects research activities. Any active protocol that previously received a full board review must come back to the Full Board for its yearly renewal. PIs who wish to continue their research projects beyond the year term should plan to submit a continuing review application before the one-year expiration date. In certain cases, a protocol that previously received Full Board review can go through an Expedited review (Category #8), so long as it meets one of the following three requirements:
  • The research is permanently closed to the enrollment of new participants;
  • All participants have completed all research-related interventions; and
  • The research remains active only for long-term follow-up of participants; or where no participants have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis.
• New Information and Unanticipated Problems: PIs must promptly report any new information or unanticipated problems that may affect the risk to participants or others. This includes any new findings that may impact the participant's willingness to continue in the study. The PI must submit a report to the IRB detailing the nature of the new information or unanticipated problem, the potential impact on the study, and any proposed changes to the protocol. Any instances of noncompliance with the approved protocol or IRB requirements must be reported to the IRB immediately. Noncompliance includes but is not limited to, deviations from the approved study procedures, failure to obtain informed consent, or failure to adhere to regulatory requirements. The PI must provide a detailed report outlining the nature of the noncompliance, the circumstances surrounding it, and any corrective actions taken to prevent recurrence.

Report the following to IRB within 5 business days of discovery. If unsure, contact the IRB ASAP.

1. New Funding and Financial Conflicts of Interest

• Types of Reports: New financial conflicts of interest or changes in funding affecting the study’s integrity.
• IRB Review Process: Expedited or Full Board Review to evaluate potential impacts on research objectivity and participant welfare.

2. New or Increased Risk/Safety Issue and Protocol Deviations

• Types of Reports: New information indicating increased or new risks, revised investigator brochures or device labeling, protocol violations or deviations that harm participants or increase their risk, and participant complaints indicating new risks. Any changes significantly increasing the risk to participants and affecting the research conduct, including any deviations from the approved research protocol that affect the study’s integrity or increase risk.

• IRB Review Process: Expedited or Full Board Review based on the severity and impact of the risk or deviation on participant safety and study conduct.

3. Unexpected Harm Related to Research

• Types of Reports: Harm that is unexpected based on previously reviewed risk information. Harm that is at least possibly related to the research procedures, in the investigator’s opinion. Serious adverse effect on health or safety, life-threatening problem, or death associated with a device or procedure not previously identified. Complaints which cannot be resolved by the research team.

• IRB Review Process: Expedited or Full Board Review based on the severity and relevance of the harm.

4. Compliance and Data Integrity Issues

• Types of Reports: Noncompliance with federal regulations or IRB requirements, inspection audit reports, written reports from study monitors, unreviewed protocol changes, premature suspension/termination of the study by sponsor or investigator, and issues affecting the integrity or validity of research data, including potential falsification or manipulation.
• IRB Review Process: Expedited or Full Board Review based on the nature, severity, and impact of the compliance and data integrity issues.

5. Breach of Confidentiality

• Types of Reports: Security incidents or breaches involving research data.
• IRB Review Process: Expedited or Full Board Review based on the severity and potential impact of the breach.

6. Informed Consent Issues and Unexpected Benefits

• Types of Reports: Problems affecting participant understanding or rights in the informed consent process, and if new, unexpected benefits were identified during the study that were not anticipated in the original IRB review.
• IRB Review Process: Expedited or Full Board Review based on the impact of the issues on participant rights, understanding, and study conduct.

7. External Reports

• Types of Reports: Early suspension or termination of the study by the sponsor, investigator, or institution, findings from additional regulatory bodies, compliance issues not covered by primary IRB oversight, significant participant complaints related to study procedures or safety, and safety monitoring or final study reports.
• IRB Review Process: Full Board Review to evaluate the circumstances, address additional regulatory findings, assess the impact on participants, and ensure proper follow-up and final reports.

The IRB cannot retrospectively approve research. Please do not begin research without IRB approval. Approved IRB protocols which deviate from the policies, procedures, stipulations, or decisions of the IRB are subject to further inquiry by the IRB.  Initially, DIEC may send the investigator(s) in question a notice requesting the suspension of all research activities while the issue of noncompliance is reviewed, consistent with Federal Mandate 45 CRF Part 46.113. This initial notice will also include a statement detailing the rationale for the IRB's action.   Finally, DIEC will investigate allegations of noncompliance.

Areas of Noncompliance IRB Inquiry Review:

• Category of Review: Determine if the study was reviewed as Exempt, Expedited, or Full Board.
• Type and Nature: Identify whether the noncompliance is general, serious, or continuing. Assess the impact on participants, research integrity, and the informed consent process.
• History of Noncompliance: Review the noncompliance history of the PI, CO-PI, and/or faculty sponsors.
• Deviation and Implications: Assess specific deviations observed and evaluate how investigators deviated from the approved protocol or failed to adhere to IRB procedures. Consider the context of these deviations, including their impact on research integrity, participants' rights and welfare, and study outcomes. Ensure there is adequate documentation supporting the described noncompliance issues.
• Reporting: Evaluate how and when the event was reported to the IRB, including the submission of the final report and Corrective Action Plan (CAP). Confirm that outcomes of corrective and preventive actions are communicated to relevant stakeholders, including participants and research staff.
• Corrective Actions: Assess the actions taken to address and mitigate the noncompliance, including necessary revisions to the protocol, study design, or other relevant aspects. Evaluate the plans for training or re-training research staff on procedures and practices to prevent recurrence of the issue. Review the monitoring measures established to ensure ongoing compliance, including how these measures will be tracked and reported.
• Preventive Actions: Examine changes made to processes or systems designed to prevent similar issues in the future. Ensure mechanisms are in place for ongoing feedback to identify potential issues early, including how feedback will be collected and addressed. Confirm that clear deadlines are provided for implementing corrective and preventive actions and identify who is responsible for overseeing these actions. Outline how the effectiveness of the corrective and preventive actions will be assessed, including any follow-up reviews or audits.

Noncompliance Process

Allegation:

1. Concerns about possible Noncompliance can be raised by DIEC, IRB Chairs, IRB members, investigators, subjects, or others. Concerns not raised by a DIEC should be forwarded to a DIEC for initial determination.
2. The DIEC may determine if the concern constitutes General Noncompliance or warrants further inquiry. Concerns determined to be greater than General Noncompliance are considered allegations and are forwarded to the Chair for review.

Investigation:

1. DIEC conducts the Investigation, contacting relevant individuals for verification of facts.
2. Once sufficient information is available regarding the allegation, a report is prepared for committee review.
3. The IRB Chair or convened IRB may accept, reject, or modify DIEC’s findings and recommendations report. Corrective actions may include changes to the research protocol, required training, research restrictions, subject notification, data destruction, publication disallowance, oversight monitoring, or protocol suspension/termination.
4. The Convened IRB, IRB Chair, or DIEC can make a final determination, including severity and corrective actions, will be documented in the IRB meeting minutes.
5. A Final Report reflecting the IRB’s final determinations is sent to the IO. If Noncompliance is found, the Report is sent to Need to Know Individuals; if not, it is provided only to the Respondent.

Outcome:

1. If the Respondent disagrees with the Final Report, they may notify the IO, DIEC, and IRB Chair, to request an appeal citing reasons for disagreement within 30 days. The IRB Chair or DIEC can make the final decision, in consultation with the IO, as necessary.
2. If the PI agrees with the Final Report or after the IRB’s final decision, the DIEC or IRB Chair ensures the corrective and preventive action plan is implemented. If necessary, a notice of closure is sent to Need to Know Individuals.

Not for Cause Audits:

1. If Noncompliance is identified during a DIEC audit, DIEC determines the type of Noncompliance.
2. If not General Noncompliance, DIEC follows the same steps for investigation, reporting, and corrective actions as detailed above.

Notification to Regulatory Agencies or Sponsors:

The DIEC reports Serious or Continuing Noncompliance to the appropriate regulatory agencies and sponsors as required. This includes OHRP, FDA (for drug and device research), and other relevant parties at the DIEC’s discretion.

If IRB approval of the Human Research expires, no human subjects activities may occur. This includes recruitment, enrollment, interventions, interactions, and collection of private identifiable information. Continuation of Human Research procedures is a violation of federal regulations. If IRB approval of the Human Research expires, the Principal Investigator (PI) must report the lapse to the IRB and include:

1. An explanation of how the lapse occurred.
2. A strong corrective action plan to avoid a future lapse.
3. The timeline for when the lapse will be resolved, either through a Continuing Review application or Study Closure.
4. Confirmation that no human subjects research activities took place during the lapse.
5. Confirmation that there are no pending issues/modifications, participant complaints/concerns, etc.
6. A statement about whether there have been prior lapses for this project.
7. Verification of the lapse has been communicated to the sponsor, local site/IRB, DSMB, etc., if/when applicable.

If it is necessary to continue Human Research activities to eliminate apparent immediate hazards to participants, prior notification is required.

Note: Consult IRB for guidance on appropriate actions for specific circumstances not covered above.

If the PI of an IRB-approved study plans to leave the university, please consider the following options:

For Active Research:

1. Transfer to Another Institution with Ongoing Enrollment: Submit a modification describing plans for notifying subjects, determining their willingness to continue participation, and safely transferring or ending subject participation.
2. Transfer to Another Institution with Completed Enrollment: Submit a modification to describe how confidentiality of identifiable data will be maintained according to subjects' consent agreements.
3. Change of PI at Current Institution: Identify a qualified individual to serve as PI and submit a modification to implement this change.
4. Data or Material Transfer: Execute an appropriate agreement before transferring any data or materials collected at the university to an external site.

For Research Not Yet Started or Concluded with Pending Publication: Submit a closure submission to the IRB.

Regardless of how a study was approved (full review, expedited review, or exempt), closure is required in any of the following situations:

• The study was not initiated and will not be.
• The study was discontinued before completion.
• The IRB-approved time period for the study has ended, and no extension was requested.
• Data collection and study-related interventions are complete, and use of identifiable data has ended.
• The PI will no longer be affiliated with UMassD and does not plan to transfer the protocol.

A study should be closed when all human subject interactions have ended and subjects are not identifiable. Studies are eligible for closure once the following criteria are met:

• Enrollment of subjects is closed.
• All research-related interventions are completed.
• Data collection is finished.
• Data are de-identified.(identifiers are separated from the coding system or stored securely).
• No additional research beyond the original intent is planned for these data.

For IRB closure requests, the study is considered complete if only data analysis using de-identified data remains. If identifiers remain on the data, researchers must request continuing review. It remains the research team's responsibility to maintain the confidentiality of the data.

The IRB may close a study without the principal investigator’s permission if:

• The principal investigator is no longer affiliated with UMassD, and no protocol transfer was arranged.
• The protocol has lapsed and no extension or closure request was made.
• An application for continuing review was submitted, but the PI has not addressed the IRB’s requests.
• The IRB determines the protocol should be terminated due to issues like misrepresentation or ethical concerns.

Closing Process:

1. Closure Request:Submit a closure report upon completion of the study before the study expiration date. The closure report is a brief summary of the research project signed by the PI and, if applicable, the faculty sponsor.
2. Confidentiality:If any risk to confidentiality remains (e.g., subjects can still be identified in the data during analysis), do not close the study until this risk is mitigated.

What to Do After Closing a Study

After closing a study, the research team must:

• Cease data collection and analysis of identifiable data.
• De-identify data and destroy identifiable data as per the protocol.
• Securely retain all study-related materials (excluding identifiable data) for three years (such as: signed consent forms, de-identified data, data collection measures, and study advertisements).

If included in the IRB-approved protocol, activities that may continue after study closure include:

• Communicating with participants for non-data collection purposes.
• Distributing remuneration.
• Fulfilling grant-related responsibilities (excluding data collection/analysis).
• Analyzing and disseminating results from de-identified data.

For additional data collection post-closure, submit a new study application to the IRB.