Investigator Guidance
Assistance for Researchers
ORRP staff hold office hours to help researchers, including graduate and undergraduate students, who are preparing Institutional Review Board submissions and exemption requests. Sessions are intended to help investigators, research staff, students and their faculty advisors navigate IRB forms, policies and review procedures.
Templates and Sample Research Documents
- Consent, Assent, & Parental Permission
- Short Form Consent for Non-English Speaking Participants
- Verbal Consent Script and Contact Information Card
- HIPAA Research Authorization
- Guidelines for Writing a Research Protocol
- Guidelines for Writing a Banking/Repository Protocol
- Communication REP Recruitment – Website Posting Template
- Psychology REP Recruitment – Website Posting Template
- Linguistics LOC Recruitment – Website Posting Template
Investigator/Staff Guidance by Topic
- Collaborative Research – Tools for Investigators
- Community Engaged Research
- Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions (SACHRP)
- Criteria for IRB review and approval (IRB Reviewer Reference Sheets – 02/24/2022)
- CTSA Data and Safety Monitoring Board Training Manual for Investigator-Initiated Studies
- Data and/or Specimen Banking and Research Use of Banked Materials
- dbGaP and Other Genomic Data Sharing
- Event Reporting
- Exempt Research
- FAQs, Terms and Recommendations on Informed Consent and Research Use of Biospecimens (SACHRP)
- FDA Inspections
- FDA-Regulated Drug Studies – Tools for Investigators
- FDA-Regulated Medical Device Studies – Tools for Investigators
- Human Subjects Regulations Decision Charts (OHRP)
- Medical Marijuana FAQs
- NIH online genetics course for social and behavioral scientists
- QA, QI, and Human Subjects Research
- Virtual Reality and Human Subjects Research
Educational Presentations
- Mock IRB Meeting (ORRP) – This presentation simulates IRB meeting discussions and interactions
- ORRP Educational Sessions – presentation slides and recordings from various ORRP educational offerings
- OHRP Educational Videos (HHS YouTube channel)
- General Informed Consent Requirements
- Research Use of Human Biological Specimens and Other Private Information
- Reviewing and Reporting Unanticipated Problems and Adverse Events
- IRB Membership
- Prisoner Research 1: 45 CFR 46 Subpart C—Basics
- Prisoner Research 2: Considerations When a Subject Becomes a Prisoner
- OHRP Exploratory Workshops
- Beyond Altruism – Exploring Payment for Research Participation (09/15/2022)
- Review of Third-Party Research Risk: Is There a Role for IRBs? (09/24/2021)
- Practical & Ethical Considerations for Single IRB Review (09/17/2020)
- Privacy and Health Research in a Data-Driven World (09/19/2019)
- Meeting New Challenges in Informed Consent in Clinical Research (09/07/2018)
- ORI and OHRP Educational Video
- PRIM&R Webinar Recordings
Student Researchers
- On Being a Scientist: Third Edition (The National Academies Press)
- webGURU (Northeastern University) – Interactive guide for undergraduate researchers
