The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.
The Committee wishes to thank Kurt Barnhart, MD, MSCE; Jeffrey Ecker, MD; and Carol Tauer, PhD; for their assistance in the development of this document.
ABSTRACT: Recent advances in reproductive medicine include treatment of subfertility as well as investigation of agents that may serve as both contraceptives and potential prophylaxis against sexually transmitted diseases, including potential protection from human immunodeficiency virus (HIV). Although there is no doubt regarding the need for informed consent by women participating in trials evaluating the safety and effectiveness of these novel agents and treatments, there has been some debate regarding the necessity and propriety of requiring consent from the partners of women involved in certain types of clinical trials involving reproductive health. Issues of partner consent are unique to research surrounding women's reproductive health as opposed to research pertaining to women's health, in general. This is due, in part, to a valid concern about a potential effect of the research on the partner. There are, therefore, legitimate reasons to obtain partner consent for a woman's participation in a clinical trial. In the absence of such reason, partner consent should not be mandated.
A large number of clinical trials are currently being conducted in nearly every therapeutic area, including women's health. Women may be motivated to participate in clinical trials by altruism to further the care of women, by the ability to receive novel and state-of-the-art medical care, or by the benefits of highly supervised medical monitoring of treatment. Often women without health insurance choose to participate in these trials because such trials may provide enhanced access to care, the care provided is often rendered without cost, and there is reimbursement for time and travel. The American College of Obstetricians and Gynecologists supports the development of new devices and medications to advance women's health and reproductive options. The American College of Obstetricians and Gynecologists also endorses the highest ethical and moral conduct of clinical research. All women, regardless of socioeconomic status and race, should have access to enrollment in clinical trials. The decision to enter a clinical trial should be autonomous, without coercion, and after informed consent. Informed consent is the ability to understand the risks and benefits of one's participation in a research activity and to authorize one's participation in this activity freely (1).
A research subject is defined as "An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control." (2). In research on women's reproductive health, sometimes both the woman and her partner will be the subjects. For example, in a study designed to identify any risk or harm to a partner of a new contraceptive method, both the woman and her partner may be research subjects. If a partner is a subject in the research, informed consent for both participants is required. This Committee Opinion primarily addresses the need for partner consent in research for which the woman, and not a partner, is the research subject. The respect for the autonomy of research subjects to consent to participation is one of the pillars of The Belmont Report, promulgated by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979 (3). The decision to reproduce or use contraceptives should remain autonomous for a woman even when enrolled in a clinical trial.
It also is important to note that the discussion and recommendations that follow do not pertain to research involving pregnant women. There are specific regulations that apply to federally funded research involving this population (4).
Partner Consent Requirement Inconsistencies
Recent advances in reproductive medicine include treatment of subfertility as well as investigation of agents that may serve as both contraceptives and potential prophylaxis against sexually transmitted diseases, including potential protection from human immunodeficiency virus (HIV). Although there is no doubt regarding the need for informed consent by women participating in trials evaluating the safety and effectiveness of these novel agents and treatments, there has been some debate regarding the necessity and propriety of requiring consent from the partners of women involved in certain types of clinical trials involving reproductive health. Some local institutional review boards (IRB) have requested consent of a woman's partner and at other times a trial sponsor or an individual investigator has made the decision unilaterally. Because of the lack of guidance on this issue, there is great inconsistency regarding requirements for partner consent and the manner in which partner consent is obtained (see box "Methods of Obtaining Partner Consent").
When Is Partner Consent Needed?
Issues of partner consent are unique to research surrounding women's reproductive health as opposed to research pertaining to women's health, in general. This is partly due to a valid concern about a potential impact of the research on the partner. Therefore, there are legitimate reasons to obtain partner consent for a woman's participation in a clinical trial. In the absence of such reason, partner consent should not be mandated. Partner consent should be obtained if:
- A sexual partner is a subject in the same clinical trial as the woman.
- A partner will be exposed to a novel agent and there is a potential for more than minimal risks* of exposure to the investigational agent.
- Data will be collected regarding a partner's acceptance of the investigational agent, or the impact of partner's acceptance of the agent on the female participant.
- Inclusion or exclusion criteria directly relate to a partner, for example, if testing of a partner is required for a woman to enroll in the trial (eg, semen analysis or testing for a sexually transmitted disease).
If, after careful consideration, it is determined that none of the previous conditions apply, partner consent is not warranted because it should not needlessly:
- Impose a barrier to participation for a woman
- Interfere with a woman's choice of reproductive options
- Interfere with a woman's right to make independent decisions about her reproductive health care due to an IRB's or regulatory agency's paternalistic reasons for partner consent
Methods of Obtaining Partner Consent
Several methods exist that may be used to obtain partner consent regarding a woman's participation in a clinical trial. The suitability of these methods depends on the particular research study. Some ways of obtaining partner consent include:
- Having a partner attend the screening visit and sign the consent at that time
- Giving a copy of the consent to the participant and having a partner come in for a separate visit to consent
- Mailing the consent and having it mailed back
- Performing the informed consent process over the telephone
- Obtaining a single informed consent that is signed by the woman and partner
Recognizing the complexities of the conduct and consent requirements for trials in women's reproductive health, the following recommendations are made:
- The partner consent requirements of each clinical trial need to be individually evaluated and based on the best available scientific and medical evidence and ethical principles.
- When partner consent is required, efforts should be undertaken to decrease the likelihood that receipt of such consent will be a barrier for participation of a woman interested in enrolling in such a trial. The addition of consent adds complexity to all trials, often resulting in additional visits for the participant and partner. This can result in fewer women enrolling and a decrease in compliance.
- Whenever possible, the choice of a woman to enroll in a clinical trial regarding her reproductive function and health should be hers alone when it does not also include a partner as a research subject. In these instances, the woman, not the IRB or the researcher(s), considering the research study should determine the extent to which a partner is to be involved in the process of informed consent and the decision to participate. For example:
- In the case of the study of a microbicide or barrier contraception efficacy, the risk to a partner is likely negligible (compared with the female partner) because of minimal contact time. If potential irritation to a male partner is suspected, it should be ruled out in the early stages of clinical investigation.
- In contraceptive research where the participant may face an unintended pregnancy, a partner may be a potential father with the resultant legal and moral responsibilities for the child. However, the principle of autonomy, allowing a woman to make a choice to enter a trial regarding her reproductive rights, should take precedence (5). The American College of Obstetricians and Gynecologists does not support recognition of distinct paternal rights before the birth of a child (6).
- Regardless of the requirement for partner consent, communication with a partner about reproductive health and contraception use should be encouraged.
*According to applicable federal regulations, "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." (45 C.F.R §46.102[I]).
- American College of Obstetricians and Gynecologists. Informed consent. In: Ethics in obstetrics and gynecology. 2nd ed. Washington (DC): ACOG; 2004. p. 9–17.
- International Conference On Harmonisation. Guideline for good clinical practice. ICH Harmonised Tripartite Guideline E6. London: ICH; 1997. Available at: http://www.proclinica.fr/GCPICH.pdf. Retrieved August 26, 2004.
- The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington, DC: U.S Department of Health and Human Services; 1979. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. Retrieved August 26, 2004.
- Protection of human subjects. 45 C.F.R §46 (2003). Available at: http://www.access.gpo.gov/nara/cfr/waisidx_03/45cfr46_03.html. Retrieved August 27, 2004.
- 5. Holder AR. Contraceptive research: do sex partners have rights? IRB 1982;4(2):6–7.
- American College of Obstetricians and Gynecologists. Research involving women. In: Ethics in obstetrics and gynecology. 2nd ed. Washington (DC): ACOG; 2004. p. 86–91.
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Partner consent for participation in women's reproductive health research.
ACOG Committee Opinion No. 307.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:1467–9.