A–Z Resources
This A–Z index provides a comprehensive list of resources available through the Office for Human Subject Protection (OHSP), including policies, guidelines, webpages, training materials, templates and reference materials. Links to other research-related institutional offices, support materials, as well as external resources are also provided.
If you have questions or need help accessing these materials, please contact us.
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Resources list
A
- Acronyms and abbreviations
- Agreements
- Ancillary Committee Reviews
C
- Center for Advanced Brain Imaging & Neurophysiology
- Center for Advanced Research Technologies
- Center for Health + Technology
- Certificates of Confidentiality
- Children
- Click IRB
- Clinical & Translational Science Institute (CTSI)
- Clinical Materials Services Unit
- Clinical Research Center (CTSI)
- Clinical Research Billing
- Clinical Trials Coordination Center
- ClinicalTrials.gov
- Concept Studies
- Conflict of interest
- Continuing Review
- Coordinating Center Studies
D
- Data and Safety Monitoring
- Data Management and Sharing
- Data Security
- Decisional Impairment
- Department & Scientific Review
- Department of Defense
- Department of Health & Human Services (DHHS)
- Devices
- Drugs, Biologics & Supplements
E
- e-Consent
- Educational Research
- Emergency Use
- Emergency Medicine Research Committee
- Expanded Access (CTSI)
F
- Food & Drug Administration (FDA)
- Federalwide Assurances
G
- Genetic Testing
- General Data Protection Regulation (European Union GDPR)
- Genomic Data Sharing Template Language
- Good Clinical Practice (GCP)
H
- HIPAA
- OHSP Policy 702: HIPAA Privacy Rule
- HIPAA Homepage
- OHSP Explains: Navigating HIPAA Compliance in Human Subject Research: The Privacy Rule
- OHSP Explains: Navigating HIPAA Compliance in Human Subject Research: The Security Rule
- OHSP FAQ: What is a covered entity and how does it affect my research?
- URMC & Affiliates Notice of Privacy Practices (English)
- URMC & Affiliates Notice of Privacy Practices (Spanish)
- URMC & Affiliates HIPAA Policy & Training Manual
- URMC & Affiliates Research Forms & Guidance (including HIPAA Forms for: Reviews Preparatory to Research [25.3]; Research on Decedent’s Information [25.4]; De-identified Information [25.5.1, 25.5.2]; and Limited Data Sets/Data Use Agreements [25.6.1, 25.6.2, 25.6.3])
- HIV Testing
- Home Visits
- Human Research Protection Program (HRPP)
- Human Subject Protection (HSP) Training
I
- Imaging Science Clinical Trial Services
- Integrated Online Research Administration (IORA) Grants, Awards & Agreements Resources
- Informed Consent
- Institutional Biosafety Committee
- IRB Coordinator
- IRB Fee Schedule
- IRB Membership
- OHSP Policy 302: RSRB Membership & Composition
- OHSP Policy 303: Board Member Conflict of Interest
- OHSP Board Member Resources (**Access is restricted to current RSRB Members only**)
- OHSP Guideline for Board Member Terms of Appointment & Evaluation
- Request for IRB Membership Information
- IRB Scope
- OHSP Policy 301: RSRB Scope and Authority
- OHSP Guideline for Determining Engagement in Research
- OHSP Guideline for Determining Human Subject Research
- Research vs. QI Determination Checklist
- When Do You Need to Get IRB Approval?
- FAQ: I reviewed the determination checklist above and I’m still unsure whether IRB review is required for my project?
- FAQ: My funding agency requires documentation from the IRB confirming a proposal does not involve human subject research. How does this get reviewed?
- FAQ: Do proposals that qualify for IRB exemption need IRB review?
-
- IRB Overview
- Getting Started with Your Human Subject Research Guide and Flowchart
- Preparing your IRB Submission
- RSRB (IRB) Exemptions
- RSRB (IRB) Review Process
- IRB Submission Checklist
- Criteria for IRB Approval
- Deferred vs. Modifications to Secure Approval
- OHSP Policy 401: Functions of the RSRB Office
- OHSP Policy 402: RSRB Meetings
- OHSP Policy 403: Notification of RSRB Determinations
- OHSP Policy 405: HRPP Maintenance of Records
- OHSP Policy 501: Levels of RSRB Review
- OHSP Policy 502: Types of RSRB Submissions
- FAQ: What is the difference between a ‘not human subject research’ and ‘exemption’ determination?
- FAQ: What is the difference between exempt and expedited reviews?
- FAQ: What are the RSRB’s submission deadlines for convened board review?
- FAQ: What is the difference between the approval and effective date?
- FAQ: When can I close a study with the IRB/RSRB?
- Intellectual Property
- International Research
- Internet Research
- Investigational Drug Service (IDS)
M
P
- Participating in Research at the University
- Pathology & Laboratory Medicine
- Payment
- OHSP Policy 703: Recruitment & Subject Payment
- OHSP Guideline for Subject Payment
- OHSP Guideline for Payment to Subjects to Recruit Other Subjects (Peer Recruiters)
- FAQ: What does the RSRB consider reasonable in terms of payment to subjects for participation?
- University Accounts Payable Policies & Procedures
- University Policy on Enrollment Incentive Payments by or to University Clinical Trial Researchers
- Advarra Participant Payment System
- Placebo
- Policies
- Pregnant Women
- Prisoners
- Privacy & Confidentiality
- Professional Research Certification
- Protocols
- Protocol Deviations
R
- Radiation Safety
- Recruitment
- REDCap
- Reliance
- Reportable Events
- Repositories
- OHSP Guideline for Research Involving Repositories (Databases, Repositories & Registries)
- Research Definition
- Risk Assessment
S
- Screening & Enrollment
- Secondary Use of Data, Records & Specimens/Chart Reviews
- SMART IRB
- Social Media
- Study Coordinators Organization for Research & Education (SCORE)
- Study Documentation
-
-
- What does ALCOA stand for?
- What is a certified copy?
- How do I correct a mistake on a study document?
- What is a note to file?
- What is a protocol deviation log?
- What are ‘tracked changes’? How do I track revisions to a document?
- What is a CV? Do I need one? How do I write a CV?
- How do you redact a study record for the purposes of remote monitoring?
-
- Study Start-Up Manual (Clinical Research, CTSI)
- Study Team Members & Responsibilities
- Identifying Study Team Members on IRB Submissions
- University PI Eligibility Policy
- OHSP Policy 901: Investigator Responsibilities
- OHSP Guideline on Residents, Interns, ACGME-Approved Fellowships as Study Coordinators
- OHSP Guideline for Investigators Leaving the Institution
- OHSP Explains: Leaving the University? A PI’s Departing To-Do List
- OHSP Explains: Leaving your Position? A Study Team Member’s Departing To-Do List
T
- Translator Attestation
- Training & Onboarding Resources
-
- HRPP Training Requirements
- OHSP Resources
- Training Overview
- Guideline for Training Research Personnel
- Informed Consent: Refresher Training
- Training Framework
- Training Tools
- UR-HRPP Educational Forum and Materials
- Refresher Training:
- ORPA Continuous Learning for Administrators of Sponsored Programs
- ORS Investigational New Drug (IND) Training
- ORS Investigational Device Exemption (IDE) Training