Scientific Review of Human Subject Research Protocols

Purpose

To establish the process and core requirements for scientific review of human research protocols within the Department of EMPHS.

Scope

Applies to all human-subject research protocols, prior to review by the Institutional Review Board, as set forth by the URochester Office for Human Subject Protection

Responsibilities

1. All faculty and staff who engage in research involving human-subjects must have certification in human subjects protection commensurate with the degree of risk to participants in the research (HSPP or EPRP).
2. Principal Investigators (PIs) submitting protocols for IRB review must be familiar with UR Research Subjects Review Board (RSRB) Investigator Guidance, including required elements of a written research protocol¹
3. It is the responsibility of the faculty member in charge of the research (PI) to prepare and submit the documents for review.
4. The Chair of the Department of EMPHS will serve as the professionally credentialed researcher or will delegate scientific review to one or more individuals with appropriate research experience. The reviewer will have, as appropriate, findings from related departmental reviews, including assessment of investigator qualifications and sufficiency of resources, to support scientific review.
5. Through discussion with the PI and review of research documents, the scientific reviewer will evaluate adherence to these core requirements, commensurate with the category of anticipated risks of potential harm:
   1. Scientific Merit
      1. The protocol background supports the proposed study;
      2. The protocol provides well-framed, testable hypotheses and/or well-framed study aims;
      3. The study design and strategies are adequate to test the hypothesis and/or to achieve the study aims;
      4. The analysis plan and methods are adequate to test the hypothesis and/or achieve study aims;
      5. The proposed research may provide societal benefits.
   2. Risk Identification and Management
      1. Identify any foreseeable risks to research participants;
      2. Reasonable means to mitigate risks have been employed;
      3. Data and safety monitoring procedures appropriate to the design, specific risks and risk level of the study, and are adequate to safeguard the rights and welfare of study subjects.
   3. Investigator Qualifications and Resources
      1. The investigative team has the necessary skills and experience to bring the research project to a successful conclusion;
      2. The investigator has time and resources to conduct the research, including study treatments and/or data collections strategies;
      3. The investigator has a process to ensure adequate training and supervision of the study team.
6. Upon completion of scientific review, the Reviewer will complete a Scientific Review Form and will either: 
   1. Sign-off and upload this to the IRB electronic submission system as part of the departmental review, or 
   2. Return the protocol to the PI with specific feedback regarding identified gaps in information or concerns to address, so that appropriate modifications can be made before resubmission for scientific review. If this action is taken by a designee of the Department chair, then the Chair will be notified by the designated reviewer that the protocol was returned to the PI (with a brief description indicating the reason). 
7. Department sign-off on human subjects protocols attests the scientific merit of the proposed study, evaluation of risk identification and management, and assessment of investigator qualifications and available resources.

¹https://www.rochester.edu/ohsp/templates/