Our Services
Our office provides a variety of services, templates, and resources that can help you throughout your research work. Explore some of these opportunities below.
Onboarding, training, and professional development
OHSP provides training opportunities and resources to support study teams —some of which are required by federal agencies, institutional policy, and study sponsors. Our training-related resources are summarized below. Visit our Training page to explore all of these opportunities.
Human Subject Protection (HSP) training is required to engage in human subject research. Some study sponsors and funding agencies further require Good Clinical Practice (GCP) training. These types of training are available through an online platform called the Collaborative Training Initiative (CITI). For additional information, visit our Required Training page.
- Training framework: OHSP has developed online training courses to aid in the professional development of faculty and staff conducting human subject research. For additional information, visit our Training Framework page.
- Customized, small group training: Upon request, OHSP can lead training sessions on the research topic of your choice for your team. Examples include an overview of the IRB review process for students/residents, a team refresher on good documentation practices, and more. To learn more and request a session, contact Kelly Unsworth at kelly_unsworth@urmc.rochester.edu.
- Monthly forums: OHSP hosts monthly educational sessions around a variety of research topics, which are a great way for you to stay up-to-date. Visit our Forums page to learn more.
RSRB (IRB) review
An Institutional Review Board (IRB) is a committee, constituted per federally-defined membership requirements, tasked with reviewing human subject research to ensure subject rights, safety and welfare are protected. The University of Rochester’s IRB is referred to as the Research Subjects Review Board (RSRB). RSRB review is required for all human subject research, regardless of sponsorship, conducted or supported by employees or agents of the University.
Quality Improvement reviews
The OHSP Division of Quality Improvement (OHSP-QI) conducts routine and directed (for cause) QI reviews to evaluate:
- Compliance with the IRB-approved protocol; and
- Applicable federal and state regulations and guidance, and institutional policy.
Study teams can also request a free review by contacting the OHSP Quality Improvement Team. Reach out to our team at ohspqi@urmc.rochester.edu to learn more.
Quality-related consultations
OHSP-QI can consult with you about a variety of topics, some of which are outlined below. If you’d like to connect with us to discuss further, contact ohspqi@urmc.rochester.edu.
Post-Approval Consultations
Free consultations are available to help set study teams up for success in achieving compliance with the regulations, policies, and guidance applicable to their specific study. Consultations can be requested following IRB/RSRB approval, but prior to initiating the research.
Quality Management Plan guidance and consultation
Assessing quality in research is often reactive. Errors are not identified and addressed until after they offer. Quality management should be a proactive effort, whereby research quality is continuously assessed. To support such efforts, OHSP-QI has developed a Quality Management Plan (QMP) Guide. Free Quality Management Consultations to support study teams in planning and implementing their QMP are also available.
Templates
OHSP has a variety of templates to guide your research efforts. Visit our Templates page for a comprehensive overview. Explore some of our frequently-requested template types below.
Protocol and consent templates are available to serve as starting points for developing research protocols and consent documents. These templates include the elements necessary for an Institutional Review Board (IRB) to make determinations required by federal regulations and/or institutional policy.
Study Documentation Resources, including modifiable templates, are available to help study teams document and track study activities.
Self-Audit Tools are available for study teams to assess and review the quality of their study documentation. These tools can be customized and used:
- For general quality-related reviews (e.g., as part of an informal self-check);
- To support implementation of a Quality Management Plan; or
- To prepare for a quality improvement review, monitoring visit, audit or inspection.
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