Reproductive Risk in Clinical Research
No reference to contraception may be used in the informed consent form or any other materials shared with research participants. 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.
Policies & Procedures
- Approval of Research
- Continuing Review
- Deception in Research
- Definitions
- Departmental Review Boards
- Dietary Supplements
- Exempt Review of Research
- Expedited Review of Research
- Full Review of Research
- General Application Procedures
- Incentives in Research
- Informed Consent, Parental Consent and Child Assent
- International Research
- IRB Administration
- IRB Review Process
- Mandatory Training
- Misconduct
- Non-English Speaking Participants
- Oral History
- Overview
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Required Reporting
- Responsibilities of Investigators and Sponsors
- Revisions to Previously Approved Research
- Sponsorship
- Student Research
- Submission of Applications
- University Policy on Human Research
- Whistleblower Policy
For IRB or IRBNet questions, please contact irbhelp@marywood.edu.
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Keith J. O'Neill Center for Healthy Families, Room 208 | 570-348-6211, x.2233