Standard Operating Procedures - Chapter 10

OPERATIONS OF THE IRB

10.1 Initial Applications

Submission of New Applications

UMASS provides application forms for new studies through its website. All applications submitted for IRB review are screened in the HRPO for completeness before determining the appropriate review level. A complete submission for IRB review includes the following, when applicable: (1) application form “441”; (2) abstract; (3) informed consent document(s); (4) recruitment materials to include ads, flyers, phone screening procedures, scripts, and/or screening questions; (5) survey instruments; (6) other materials specific to the proposed study (e.g., grant application, investigator’s brochure, sponsor correspondence with a regulatory agency such as the FDA regarding test item risk, etc.); and (7) training certificates.

If the application is incomplete or poorly prepared for review, it may be returned to the principal investigator with a request for necessary changes or additional information. The Principal Investigator (PI) may be contacted requesting clarification of study issues prior to IRB review. Once a complete application with supporting documents is received, it is assigned an IRB number that remains with the study.

Determination of Review Level

The HPA or support personnel, as designated by the Chair, screens the entire application and supporting documents for completeness and forwards to the Chair. Studies are assigned to full board review unless: (1) criteria for an expedited review (45 CFR 46.110) are met (Chapter 10.1 below) or (2) criteria for an exemption review (45 CFR 46.101(b)) are met (see Section 10.1 below). All studies involving the use of investigational drugs, devices, or biologics for which an Investigational New Drug (IND)/Investigational Device Application (IDE) is required, receive full board review. Studies involving prisoners receive full board review unless the study involves minimal risk as defined for prisoner populations, in which case it may receive expedited review.

Full Board Review Process

• Scheduling of Meetings

The IRB meets once monthly. Meetings may be cancelled by the Chair in consultation with the HPA due to: (1) insufficient studies requiring full board review; (2) an inability to secure a quorum for attendance; or (3) other reasons that may arise that make a scheduled meeting unnecessary or otherwise inappropriate. The Chair and/or HPA may schedule additional meetings or reschedule a meeting as necessary.

• Pre-Meeting Distributions to Members

The meeting agendas and study materials are prepared and distributed to IRB members approximately 10 days in advance to allow adequate time for a thorough review process. The agenda indicates: (1) the meeting date, time, and location; (2) new proposals, modifications, continuing reviews, adverse events, and responses to be reviewed; and (3) any other activities to be discussed at the meeting as determined by the IRB Chair or HPA.

The IRB members receive documentation for each item listed on the agenda (if documents are applicable). Specifically, IRB members receive: (1) protocol application forms and supporting materials; (2) copies of the continuing renewal requests and supporting documentation; (3) copies of modifications/revisions and supporting documents; (4) adverse event information; (5) previous meeting minutes for review and approval; (6) reports of research approved by the expedited review process; and (7) any other materials as determined by the IRB Chair and/or HPA. Before these materials are distributed to the IRB members, the HPA may communicate with the investigator(s) or a research contact person to clarify any issues that may arise from the pre-review of the new application, continuing renewal, or revision submission.

• Primary and Secondary Reviewers

Two IRB members serve as primary and secondary reviewers for new studies requiring full board review. The HPA assigns reviewers in advance of a full board meeting. The Chair may serve as a reviewer. In selecting the reviewers, consideration is given to the individual’s knowledge of the subject area embodied in the proposal, as well as any known potential conflict of interest. Primary and secondary reviewers are also assigned for continuing reviews or study modifications that require full board review.

The primary reviewer leads the discussion of the new study or continuing review application at the IRB meeting. In the absence of the primary reviewer, these roles default to the secondary reviewer. In addition to the assigned reviewers, the rest of the IRB members review the application and supporting documents.

• Voting and Quorum Requirements

• o Quorum Required to Transact Business

To transact business, a majority (one over half) of the IRB members (or their designated alternates), including at least one member whose primary concerns are in nonscientific areas, must be present to conduct a full board meeting. If the full IRB reviews research involving prisoners, an ex-prisoner or prisoner representative attends as a voting member for federally funded research.

Members may be present in person or audio or audio-visual teleconference. Members present via teleconference are noted as such in the meeting minutes. Such members must receive all pertinent information prior to the meeting and be able to actively and equally participate in all discussions. IRB minutes record the quorum and votes for each IRB action and determination. Members excusing themselves due to conflicts of interest may not be counted toward quorum requirements (i.e., may not be counted among those voting or abstaining). IRB minutes list the names of the members excusing themselves from participation due to conflicts by study.

o Types of Voting:

IRB members may cast a vote for or against a motion, or abstain. Voting is conducted by verbal “yea” or “nay” or a show of hands. The official meeting minutes record, without individual identification, the number of votes to approve, disapprove, no decision or abstain. It is the policy of the IRB to attempt to gain a consensus of the IRB members during the conduct of the study review before calling for a vote. A majority vote of the members present at the meeting is required for approval.

When the Chair is absent from a meeting the Vice-Chair, or member assigned by the Chair, fills in.

Only individuals listed on the official IRB membership roster as voting members may vote. Alternate members may vote only when the regular member for whom they are authorized to replace is not present at the meeting or is attending the meeting in a non-voting capacity. Under this circumstance, the alternate member holds the full voting rights in place of the regular member. An alternate may cast only one vote, even if authorized to replace two regular members and both of the latter are absent. Members unable to attend a meeting (and not available via audio or audio-visual teleconference) cannot vote in absentia.

o Types of Motions:

The IRB will make a motion for each application request (e.g., new study, modification, continuing review) presented to it. All voting members may vote upon studies according to the following types of motions or another motion offered:

• Approved with no required changes. The research may proceed.
• Approved with minor changes clearly delineated by the IRB so that the investigator may simply concur with the IRB’s stipulations. The research may proceed after a designated IRB member, verifies the required changes. The IRB member is often the primary review assigned to the study or the HPA.
• Deferred or tabled pending receipt of additional substantive information. The IRB has determined that the application and supporting documents lack sufficient information to proceed with its review. The research may not proceed until the full IRB has approved a revised application incorporating all the requested information.
• Disapproved. The IRB has determined that the research cannot be conducted as proposed at UMASS.
  
• Role of Investigator at IRB Meetings

When new studies are to be discussed at the meeting, PIs (and key personnel, if applicable) may be invited to attend the meeting to discuss their study with the IRB. An investigator and advisor (if applicable) may be required to attend the meeting for other reasons such as modification requests, non-compliance issues, adverse events, etc.

The outcome of the IRB decision at the Full Board meeting is communicated to the Principal Investigator. Copies of all approval letters are sent to the Office of Grant & Contract Administration (OGCA) if the project is sponsored.

Expedited Review Process

The expedited review process is used in accordance with federal regulations for studies that qualify for expedited review. The IRB Chair, or their designees, is responsible for overseeing these reviews. The expedited review process may be used for studies involving no more than minimal risk as indicted in the following examples:

1. Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows: (a) from healthy, non-pregnant adults, who weigh at least 110 pounds. For these participants, amounts drawn may not exceed 550 ml in an 8 weeks period and no more than 2 times per week; or (b) from other adults and children, considering age, weight, and health of the participants, collection procedure, amount of blood to be collected, and frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml/kg in an 8-week period and collection may not occur more frequently than 2 times per week.

2. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) excreta and external secretions (including sweat); (c) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax; (d) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings.

3. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice. Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencelphalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

4. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

5. Collection of data from voice, video, digital, or image recordings made for research purposes.

6. 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.

7. Continuing review of research previously approved by the full IRB (a) where the research is permanently closed to the enrollment of new participants, and all participants have completed all research-related interventions, and the research remains active only for long-term follow-up of participants; or (b) where no participants have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.

Federal regulations define minimal risk as the “probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102(i)). In addition, expedited review cannot be used where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability, or be damaging to the participants’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections are implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

The Chair or his/her designee(s) review the supporting documentation provided with the application, including the grant, if applicable. The IRB Chair or his/her designee may approve studies as submitted or require modifications prior to approval. They are not empowered to disapprove studies reviewed through the expedited process; in such cases, the study must be submitted for full board review along with the comments and recommendations of the chair or his/her designee. Approved expedited studies are subject to at least an annual review. This information is communicated to the principal investigator in the approval letter. Copies of all sponsored project with expedited review approval letters are forwarded to the Office of Grant and Contract Administration (OGCA). Studies that are reviewed and approved through the expedited process are reported to all IRB members at the next IRB meeting.

Exempt Review Process

Certain types of research may be found by the IRB to be “exempt” from IRB oversight (45 CFR 46.101[b]). Investigators, however, may not make an independent determination that research is “exempt” from the review process. Only a designated IRB member or qualified staff from the HRPO have the authority to determine if a research study is “exempt” from IRB oversight. The determination can be made only following careful review of a research study. Documentation of verified exemptions will be included in the IRB research study file. The HRPO will communicate the exempt status in writing to the investigator.

Exemptions are limited to research involving no more than minimal risk. Research that qualifies for exemption from the requirements must fall within one or more of the six exempt categories:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special educational instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (a) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and (b) any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior not otherwise exempt under the above two categories if the human participants are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants. NOTE: Research falling into this category must involve only data, documents, records or specimens that are in existence at the start of the study.

5. Research and demonstration studies which are designed to study, evaluate, or otherwise examine public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payments for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies if wholesome foods without additives are consumed; or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the United States Department of Agriculture (USDA).

Exemptions are not available for all kinds of research such as:

• Research involving prisoners or focused primarily on pregnant women or fetuses
• Survey research involving children that would fall into category 2
• Observational research of children.

Investigators conducting research designated by the UMASS IRB as exempt are required to (1) report any proposed changes in the research activity that may affect the exempt status and (2) obtain IRB review before such changes are initiated, except where necessary to eliminate apparent immediate hazards to the participant. Investigators must also report any unanticipated problems involving risk to participants or others that occur as a result of participation in exempt research.

Approval letters listing the approval level and a summary of Principal Investigator responsibilities are forwarded to the PI and OGCA, if sponsored. Investigators are asked to submit a final report to the HRPO upon completion of the study.

Length of Approval

Approval is granted for a maximum of one year; approval periods requiring more frequent review may be designated when appropriate. For research reviewed by the full board, the period of approval begins on the date of the IRB meeting where approval was granted. Continuing review must occur within 1 year of the date of the convened IRB meeting at which the IRB reviewed and approved the study. For research reviewed by the expedited process, the period of approval is no greater than 365 days from the date of review and approval.

10.2 Continuing Reviews

Continuing review is the responsibility of the Investigator. The HRPO assists in the process by sending the IRB Continuing/Final Report Form to the principal investigator and/or designated contact person 45 days before the approval expiration date. If the Report has not been received within 14 days of the approval expiration date, another Report form is sent. Research approved previously by expedited review is considered eligible for expedited review at the time of its regular continuing review, if, during the course of the study, the risks have not increased. Studies that were initially reviewed by the full board continue to receive the same level of review unless (1) the full board determines that the study meets the specific criteria for expedited continuing review as outlined in federal regulations; (2) 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; (3) no participants have been enrolled and no additional risks have been identified; and/or (4) the remaining research activities are limited to data analysis. The IRB Chair or HPA is responsible for these expedited reviews.

For research studies requiring continuing review by the full board, the review is scheduled for an IRB meeting held within 30 days of the approval expiration date. A designated IRB member serves as primary reviewer (where possible, the initial primary reviewer is used) for each research study due for continuing review. The primary reviewer has access to the complete IRB study file and reviews the study (including any modifications previously approved by the IRB), Continuing/Final Report, consent form, adverse event listings, any complaints, and any relevant communications from the sponsor. All other IRB members receive copies of the Continuing/Final Report, abstract, Form 441, latest consent form and any other forms that the PI may have included as part of the agenda packet distributed before the meeting. The reviewer summarizes the activity and progress of the study for the IRB and makes a recommendation about re-approval for another time period as defined by the IRB. The IRB votes on each continuing review study.

Principal investigators are notified in writing of the decision of the IRB and any requested changes. The IRB provides final renewal approval when all required changes have been made, reviewed and confirmed for approval. The investigator receives a memo indicating type of review, approval expiration date, and a summary of principal investigator responsibilities. If the project is sponsored, OGCA is also sent a copy of the continuation approval.

10.3 Modifications

A modification is a request by an investigator to make a change to an already approved study. Investigators must report planned changes in a study and receive approval from the IRB prior to implementing these changes, except where necessary to eliminate apparent immediate hazards to the participants. In the case of changes implemented to eliminate immediate hazards to the participants, the IRB must be notified no later then the next workday. When a principal investigator wishes to modify a study, he or she must submit these modifications to the IRB along with any supporting documentation. Modifications may include, but are not limited to:

• changes to a study
• adding or removing investigators/study personnel
• changing the participant eligibility or number
• changes in informed consent form(s).

Federal regulations permit an IRB to review research modifications through an expedited procedure if the research constitutes a minor change in previously approved research during the period for which approval is authorized. Minor changes include those that: (1) do not change the risk/benefit ratio to a participant; (2) would not change the IRB’s conditions for approval; and (3) would not impact a participant’s decision to remain in the research. The HPA or designated IRB member determines the review level of a modification for an ongoing study based on the amount of risk to the research participant.

The IRB Chair, or their designee(s), may review the following types of revisions through an expedited procedure:

• Informational revisions with no potential impact on the risks for participants, e.g., editorial changes, changes to research staff, reduction in the number of research participants, or deletion of questions on questionnaires
• Minor revisions with minimal risk to the research participant, e.g., increasing the number of participants, adding non-sensitive questions to a questionnaire, adding a standardized test, changing the recruitment plan, adding a standard quality-of-life questionnaire, extending the time period of the study to include only follow-up with the research participants, changing the principal investigator, adding a research site, revising the format of the consent form, changing telephone numbers or contact persons on the consent forms, minor changes to participant compensation, or other minor revisions to the consent forms.

Major revisions involving more than minimal risk to the research participant must be reviewed and approved by full IRB. This type of modification reflects a major change in the direction of the study that may substantially change the purpose or goals of the study or may impact a participant’s decision to remain in the research. Examples of major changes with major risks include: changes in the treatment or drug dosage or frequency, additions or deletions of research groups, revisions to eligibility criteria, or changes to the consent form to include newly identified side effects or adverse events. For revisions requiring review by the full board, the HPA reviews the modification and prepares the issue(s) for presentation to the full board.

The primary reviewer and other IRB members receive a copy of the study modification, the study summary, consent form, and any other relevant communications from the sponsor or investigator as part of the agenda packet distributed before the meeting at which the modification review is scheduled.

Modifications may require the consent to be revised to reflect study changes. Investigators must submit a revised consent form for new (not yet enrolled) participants and a consent form addendum to provide the new information to current (already enrolled) participants, if applicable. The principal investigator receives a memo indicating type of review, approval expiration date, and a summary of responsibilities.

10.4 Revisions Prior to Final Approval

Revisions to new and continuing human participant applications may be required. Correspondence is sent to the principal investigator detailing requests for revisions, clarification, or additional information. The principal investigator is expected to address the requested revisions within a given and stated time period, generally 30 to 90 days.

If a response is not received within the stated time period, a reminder is sent giving the principal investigator 10 additional business days to respond to the request. If no response is received, the study or proposed modification is withdrawn from consideration. If the principal investigator wishes to conduct a study that has been withdrawn from consideration, he/she must submit a new application or modification request for IRB review and approval.

When specific changes are requested in the application and/or supporting document(s), the responses are reviewed for compliance. When the IRB designated reviewer confirms that the final requirements are addressed, the study receives final approval. In instances where substantive revisions are requested during a full board review, the revised documents are returned to the reviewers and other Board members, if requested.

Upon final approval, the principal investigator receives a memo indicating the type of review, approval expiration date and a summary of investigator responsibilities. The memo informs the investigators of their responsibility to notify the HRPO of any additions or changes to the study. All investigators are required to submit any changes to the research study to the IRB for review and approval before implementation, except where necessary to eliminate apparent immediate hazards to the participants.

10.5 Rebuttal or Appeal of IRB Decisions

Upon written receipt of requested changes, investigators may appeal the IRB recommendations either in person or in writing. If the IRB decides to disapprove a research activity, written notification, including a statement of reasons for its decision, will be provided to the investigator. An appeal of a disapproved research study must be reviewed at a full board meeting.

10.6 Unanticipated Problems Involving Participants

Investigators must report unanticipated problems to the HRPO in a timely manner. Significant Adverse Events must be reported within 5 days (see 10.7 below). Any new trend within a protocol, serious or not, should be reported to the IRB as soon as it is noticed and recorded on the Non-Significant Adverse Event Tracking Log (See IRB Guidelines - Adverse Events).

10.7 Adverse Events Involving Risks to Participants

Adverse events, including adverse device effects and safety reports, data and safety monitoring board reports, and protocol deviations or violations, are pre-reviewed by a designated IRB member within five working days of their receipt in the HRPO. Reports that indicate minimal risk for research participants are reviewed in an expedited process. All other reports are reviewed by the full board. (See IRB Guidelines - Adverse Events). The IRB has the authority to suspend or terminate approval of human participant research if the adverse event increases the risk level to participants.

10.8 Other Monitoring Activities

On-site monitoring is conducted at the discretion of the IRB for both routine audits and for cause. Either an IRB member or a professional staff member from the HRPO acting on behalf of the IRB conducts the monitoring visit. The reasons for a routine on-site review may include (1) a random selection process, (2) complex studies involving unusual levels or types of risks to participants, or (3) studies that involve vulnerable populations, such as children or prisoners. A monitoring visit for cause may occur when (1) a continuing review of a study or report from other sources indicates that changes have occurred without prior IRB approval, or (2) investigators have failed to comply with IRB policies and procedures.

The on-site review process may include any or all of the following: (1) discussions with investigators and other study personnel to ascertain their level of knowledge of the guiding principles and policies of the IRB, (2) observation of the recruitment or consent process, (3) examination of previously signed informed consent forms, (4) observation of the research activity, (5) interviews with screened or enrolled participants, (6) examination of research records, (7) requests for progress reports and adverse event reports from investigators, and (8) educational instruction for study investigators and study personnel.

The on-site visit procedures may incorporate the following:

• The investigator is notified by letter to set up a date and time for an on-site visit. The visit time and place is confirmed 24 hours prior to the visit.
• The site auditor uses the necessary current documents from the IRB study file.
• The site auditor confirms that the study is being conducted according to the approved study and the IRB policies and procedures.
• A written report of the monitoring activity is sent to the investigator. A copy is placed in the IRB study file at the HRPO.

A follow-up to the visit may include the following:

• If the monitoring report determines that all procedures are in compliance, the report is filed in the IRB study file and a letter indicating such is sent to the principal investigator.
• If the report determines minor infractions or inconsistencies with the approved study or with IRB policies and procedures and there is no or minimal increase in risk to participants, a letter is sent to the principal investigator outlining the problem areas and an appointment is set up to review the needed changes and to educate him/her on the appropriate actions.
• If there are serious non-compliance issues or risk to participants, the standard operating procedure on the “Handling of Allegations of Non-compliance” (See Appendix A) is implemented immediately.

The results of each monitoring visit are presented and discussed at the next IRB meeting. Quality improvement will be implemented as needed. Additional guidelines and/or education will be developed when necessary.

An on-site monitoring review may involve a thorough review of the informed consent process. This includes: (1) a review of the number of consent forms signed to assess consistency with the number of participants enrolled; (2) confirmation of the use of the most currently approved form; (3) a review of the signed consent forms for all necessary signatures and dates; and (4) a review, including observation if appropriate, of the process of obtaining informed consent with a research participant.

When the monitoring is conducted with regard to the consent process, the following occurs:

• A written report of the findings is reported at the next IRB meeting and filed in the IRB study file in the HRPO.
• If necessary, appropriate education and/or remedial actions are implemented.

10.9 Non-compliance Investigations and Actions

Under institutional authority and federal regulations [Title 45 CFR 46.103(b)(5), Title 45 CFR 46.113, Title 21 CFR 56.113], IRBs are responsible to oversee the safety of research participants and may suspend or terminate human participant research that: (1) is not being conducted in accordance with federal and institutional requirements, or (2) has been associated with unexpected serious harm to participants. The IRBs are supported in this process by the HRPO. For specific information as to how allegations of non-compliance are handled by the IRBs, please see “Handling of Allegations of Non-compliance” (See Appendix A).

10.10 Monitoring the Use of Protected Health Information (PHI)

Information currently being updated.

10.11 Final Reports and Study Closure

When a study ends, is closed or canceled for any reason, a Continuing/Final Report Form must be submitted to the HRPO. This form serves as notification to the HRPO that IRB approval of the study is no longer needed.

If the principal investigator does not complete a final report by the continuing review expiration date, a memo is sent to the principal investigator (advisor, co-investigators and any other designee) stating that IRB approval has expired and the study is not longer active. This memo includes a reminder that no further human participant research activities may be conducted for the research unless IRB approval is first obtained. Copies of all memos are maintained in the IRB study file.

10.12 Urgent Review of Applications

Urgent review procedures may be invoked under limited circumstances (e.g., a principal investigator is faced with an immediate deadline beyond his or her control or a safety issue warrants immediate review). If the Chair and/or HPA permits urgent review of a study, the materials are distributed as soon as possible to IRB members to allow sufficient time for review prior to the meeting. The principal investigator and his/her advisor, if applicable, may be required to attend the meeting, or be available via telephone or videoconference, to answer any questions that arise. A quorum must be met for IRB actions to be taken. Meeting minutes will document the urgent review process.

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