IRB Policies and Procedures
Policies & Procedures
- An Overview
- Application Process and Deadlines
- Board Authority and Composition
- Board Determinations
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Definitions
- Dietary Supplements
- Exempt Review
- Expedited Review
- Full Review
- General Data Protection Regulation
- Incentives in Research
- Informed Consent and Assent
- International Research
- Mandatory Reporting
- Mandatory Training
- Misconduct
- Non-English Speaking Participants
- Oral History and Journalism
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Research Advisors
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- Whistleblower Policy
Reproductive Risk in Clinical Research
Purpose
The purpose is to describe the policies and procedure related to reproductive risk in clinical research.
Policies
No reference to contraception may be used in the informed consent form or any other materials shared with human subjects participating in research.
If reproductive risks have been identified in a proposed study, the following language is required in the informed consent form:
Avoidance of Pregnancy: The medicines and procedures used in this study may be unsafe for an unborn baby, an infant, sperm, and eggs. If you, a woman of child bearing potential, are a study/trial participant, you must agree to avoid pregnancy during your participation in this study and for ____________ months after the completion of the study (include protocol time frame as appropriate); if you, as a participant are a man, you must agree to not conceive a child during your participation in this study and for ____________ months after the completion of the study (include protocol timeframe as appropriate). If you do become pregnant during the study or if you father a child during the study, you should immediately notify Dr. ____________ (name of contact) at _____________ (contact information). In addition, if you are already pregnant or are breast feeding, you cannot participate in this study.
Procedure
Whenever reproductive risks are identified in a proposed study, the investigator includes the above language in the informed consent form’s risk section.
History
11/24/2020: Updated format and added procedures