Consult fathers, too, in research involving fetuses
IRBs may ask for informed consent by fathers
Changes to federal regulations regarding research protections for pregnant women and fetuses now require investigators to obtain the informed consent of a fetus’ or neonate’s father before certain types of research may proceed.
IRBs may need to take this change and some other recent controversial issues into consideration when revising policies regarding research involving pregnant women.
For example, another conflict that may require close IRB scrutiny involves a pregnant woman’s right to privacy vs. the safety of her fetus.
Under the revised regulations, an IRB needs to decide whether a clinical trial will benefit both the mother and the fetus, whether potential risks will be minimal to the fetus, and whether it’s necessary to obtain an informed consent from the father of the fetus, says Julie Wright, PharmD, vice chair of the Adult Health IRB at the University of Missouri-Kansas City.
IRBs also should be familiar with the federal regulations’ definitions of neonates, fetuses, and what is and not viable.
The revised 45 CFR 46, Subpart B, titled, "Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research," were published Nov. 13, 2001, in the Federal Register and went into effect in 2002. The regulations include the following provisions:
Pregnant women or fetuses may be involved in research when these conditions are met:
- when preclinical studies and studies on nonpregnant women have been conducted and have provided data for assessing potential risks to pregnant women and fetuses;
- when the risk to the fetus is caused by interventions that hold out the prospect of direct benefit to the woman or the fetus, or when there is no potential direct benefit when the risk is minimal and the research’s goal is to develop important biomedical knowledge that cannot be obtained by other means;
- when potential risks are the least possible for achieving the objectives of the research;
- when the woman’s informed consent is obtained;
- when the research has potential direct benefit only to the fetus then the informed consent of the pregnant woman and the father is obtained, except when the father is unavailable, incompetent, temporarily incapacitated, or when the pregnancy resulted from rape or incest;
- when informed consent includes information about the foreseeable impact of the research on the fetus or neonate;
- when children are pregnant, assent and permission are obtained in accord with federal regulations;
- when there are no financial or other inducements offered to the pregnant woman to terminate the pregnancy;
- when researchers will not have any part in decisions regarding terminating a pregnancy;
- when researchers will not have any part in determining the viability of a neonate.
Cover potential pregnancy in consent forms
The University of Missouri-Kansas City has ample policies protecting the needs of pregnant women and fetuses, but if the IRB were presented with a study that touched on issues raised in the revised federal regulations, then the institution and IRB would have to look at it very carefully, says John R. Baumann, PhD, director of the Office of Sponsored Programs & Research Support.
A situation more commonly encountered by IRBs involves a clinical trial in which a female subject becomes pregnant during the course of the trial, and this situation would require the investigator to report a serious adverse event, says Roger Sommi, PharmD, chair of the adult health IRB at the University of Missouri-Kansas City.
"We have not had any pregnancy studies but, clearly women of childbearing age and potential issues come up all the time," he says.
"One of the things that’s changed over the last two to three years is when you look at sponsor-developed consent forms, these tend to have a lot of information that is not necessarily helpful in discussing women who may become pregnant during a study," Sommi says. "We ended up changing the forms and simplifying the language and making a special section."
It’s important to inform women of childbearing age that there may not be a lot of knowledge about a particular drug’s impact on a fetus, and the informed consent routinely should include information about birth control, he says.
Wright was an investigator on an HIV study that had one participant who had become pregnant during the study.
"We did urine pregnancy tests at each monthly visit," Wright recalls. The woman was taken out of the study, and investigators followed her through her pregnancy and delivery, reporting the information to the Food and Drug Administration, she says. "The baby and delivery were fine," Wright adds.
Another potential issue is that some drugs may affect a woman’s hormones and disrupt the effectiveness of some pregnancy medications, so women of childbearing years need to be informed that they may have to use a barrier method of contraceptive while they are involved with the study, Wright says.
Privacy concerns could be red lights
Research involving pregnant women can pose additional problems, including privacy issues.
An IRB at the University of South Dakota in Vermillion spent six months dealing with this issue when the IRB was presented with a protocol for a five-state study of fetal alcohol syndrome that involved identifying and monitoring women who drink during pregnancy, says Howard Coker, PhD, compliance officer at the University of South Dakota.
South Dakota state law requires officials to report potentially abusive behavior toward a fetus, including drinking alcohol, he says.
The study’s goal was to assist pregnant women with drinking problems through an educational intervention that was aimed at helping them maintain sobriety, Coker adds.
However, investigators could not offer research participants a certificate of confidentiality or other privacy protection because of the state law. This meant that women who volunteered for the study could be reported to state officials and possibly face legal repercussions because of their substance use while pregnant, he says.
"The question came back to whether particular subjects would participate, and they probably wouldn’t participate if they would be immediately charged with child abuse and thrown into prison," Coker says.
While the IRB and state officials grappled with this dilemma, the study was continuing in four other states where the subjects’ privacy could be maintained without it conflicting with state reporting laws.
"Our IRB understood that there were not going to be any people becoming subjects of this study unless this issue was addressed," Coker says.
"So what took six months was the grantee discussing things with the governor’s office until they negotiated an approach that was acceptable," he adds.
In this case, South Dakota officials finally took an action that made it possible for the IRB to decide in favor of the protocol. Ultimately, the governor’s office wanted the study to proceed since its objectives involved a positive intervention, Coker says.
A decision was made to continue to require the women be reported to the state agency collecting the information, but the agency would take no action against any of the individual participants of the study, he explains.
"Once that understanding was achieved, then the IRB went ahead and approved the project," Coker says. "Then there would be no reason why they shouldn’t participate."
Changes to federal regulations regarding research protections for pregnant women and fetuses now require investigators to obtain the informed consent of a fetus or neonates father before certain types of research may proceed.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content