3.9 Contraception Requirements

Last Revised: 5/5/2025

1.0 Purpose

The purpose of this policy is to describe the contraception requirements for subjects participating in research involving drugs, devices or biologics.


2.0 Policy

It is the policy of the Organization that subjects must utilize appropriate contraception methods while participating in research with potential for reproductive toxicity.


3.0 Fetal Risk Categories


4.0 Allowable Contraception Requirements


5.0 Additional Requirements


6.0 Additional Consideration for research involving devices


ADDENDUM #1

ICF Pregnancy Risk Statements Group 2 drugs {no evidence of adverse developmental outcomes}:

PREGNANCY RISKS

Group 3 drugs {No human data but animal studies show no evidence of adverse developmental outcomes}:

PREGNANCY RISKS

Group 4 drugs {Animal studies show evidence of adverse developmental outcomes, at dose levels higher than those to be used in this study}:

PREGNANCY RISKS

Group 5 Drugs {evidence of adverse developmental outcomes; OR mechanism of action of the drug suggests the possibility of adverse developmental outcomes}:

PREGNANCY RISKS

ADDENDUM #2 (For Studies Involving Devices)

ICF Pregnancy Risk Statements are as described in Addendum #1, except the first paragraph of the Pregnancy Risks statement should be replaced with:


DOCUMENT HISTORY:  Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 11/21/2017 - revision not documented

 Revised 11/27/2024 - Revised to base contraception requirements on PLLR rather than previous FDA Use-In-Pregnancy category; revised to use gender neutral language; added comment that risks to those who can become pregnant or contribute to a pregnancy, as well as contraception requirements, will be discussed in a developmentally and cognitively appropriate manner (section 5.4); stylistic changes.

 Revised 5/5/2025 - Revised purpose to specify policy addresses contraception requirements for subjects participating in research involving drugs, devices or biologics; added additional considerations for research involving devices (sections 2.1.1 and 6.1 thru 6.5); added ADDENDUM #2 (ICF Pregnancy Risk Statements for studies involving devices); minor stylistic changes and correction of typographic errors.


Revision #10
Created 24 October 2019 21:32:42 by Autumn M Eberly
Updated 14 May 2025 15:25:26 by Robert A Lewis