Standard Operating Procedures - Chapter 5

IRB RELATIONSHIP TO OTHERS

5.1 Regulatory Authorities

As required by federal regulations and by the Assurances, the IRB will directly contact the appropriate governmental authority at OHRP and/or FDA regarding questions or to file reports of reportable events, such as serious unexpected harm to participants, serious or continuing investigator noncompliance, or termination or suspension of research studies.

5.2 Compliance with Federal Regulations

• Title 45 CFR. 46, Protection of Human Participants, U.S. Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP)
  UMASS has Assurances on file with the U.S. DHHS OHRP affirming that UMASS is in compliance with 45 CFR 46.
  
• Title 21 CFR 50, 56, 312, and 812: Food and Drug Administration (FDA)
  In studies involving products regulated by the Food and Drug Administration (FDA) regulations, UMASS IRB comply with the requirements set forth in 21 CFR 50, and 21 CFR 56, and where applicable research will comply with 21 CFR 312, and 21 CFR 812 and appropriate FDA regulations.
  
• Other Federal Departments and Agencies
  UMASS also complies with other federal regulations depending on the funding source and participants to be included in the study. For example, if federal prisoners are involved, the Department of Corrections regulations also will apply.

5.3 Institutional Official

For matters relating to the execution of its duties and responsibilities, the IRB has direct access to the authorized Institutional Officials or their designees. The signatory official for the University of Massachusetts Amherst is the Senior Vice Chancellor for Academic Affairs and Provost.

5.4 Research Investigators

Only UMASS faculty, staff and postdoctoral fellows may serve as a principal investigator (PI) on research studies. Only one PI is recognized for each study and he/she assumes ultimate responsibility for his/her research study. All official IRB correspondence is addressed to the principal investigator; other personnel, as designated by the PI, may also receive correspondence.

Student researchers (e.g., undergraduate or graduate students) may not serve as PI’s and are required to designate a faculty advisor when submitting a research study to the IRB for review.

The IRB will help to educate investigators regarding their responsibilities to conduct research in a way that minimizes any risks or harm to participants and to comply with regulatory requirements and institutional policies and procedures. Typically, the IRB staff communicates directly with the PI of each study, who in turn communicates with other investigators involved in the research. However, in the conduct of its responsibilities, the IRB may query, require responses from, or otherwise communicate directly with any personnel involved with a human participants research study, whether they are listed investigators or not, or with participants themselves.

The IRB will notify investigators of its decision to approve or disapprove research studies or of modifications required to secure IRB approval. After disapproval actions, the IRB will provide written notification of the reasons for its decision, and will give the investigator an opportunity to respond in person, in writing, or both.

5.5 Other Institutions

The IRB may agree to permit another federally sanctioned IRB to act as the IRB of record for studies to be conducted by or with the assistance of UMASS personnel or at the facilities of a second institution. The IRB may agree to function as the IRB of record for another investigator and/or institution if the study involves material collaboration from UMASS personnel. Guidance on such collaborations and a sample of an agreement can be found at OHRP under "Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement." Copies of these agreements will be maintained at the respective administrative area.

5.6 Other University Committees

The IRB copies the Institutional Biosafety Committee (IBC) in on all approved projects and communication between the IBC committee and the IRB regarding status of review and/or conditions of approval, when applicable.

• Institutional Biosafety Committee (IBC) – The primary responsibility of the IBC is to review research activities that involve potentially biohazardous materials (plant and animal pathogens, oncogenes, carcinogens, toxins and recombinant DNA), as required by University, State and Federal directives. The IBC also addresses infectious-waste disposal, and handling of human blood and tissue samples. If it is unclear as to whether a material is a potential biohazard, contact the Biological Safety Officer in Environmental Health and Safety (EHS) at 413-545-2682.

5.7 Sponsors

Unless specifically required by a sponsor, federal regulations or the IRB, no written notifications of IRB deliberations shall be provided to the sponsor of a research study. Principal investigators, in complying with the requirements related to their research obligations, serve as the link between the IRB and sponsor. The IRB does not deviate from institutional policies and procedures at the request of a sponsor.

5.8 Research Participants and Others

The IRB and/or the HRPO does not routinely communicate with research participants unless a participant calls the HRPO with questions, concerns or complaints about their research participation. These communications are handled by qualified staff in the HRPO or referred to the principal investigator. If a concern involves potential non-compliance issue, it is handled according to the Standard Operating Procedure (SOP) entitled, “Handling Allegations of Non Compliance” (See Appendix A). Each question or concern is taken seriously and handled confidentially. Federal law prohibits the discrimination against persons that bring forth legitimate concerns for investigation. Occasionally participants are contacted directly by the HRPO if there are questions regarding the conduct of a study.

For quality assurance, the IRB or HRPO may observe the consent process or other procedures involved in a research study.

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