This article is the second in a two-part joint series between Quorum and Kinetiq that discusses informed consent and other considerations related to incidental partner pregnancies in clinical research.
Imagine: A pregnant woman learns her partner may have been receiving an experimental drug when she conceived. Researchers now want to collect information about the pregnancy. A huge range of feelings could spring up, including fear and worry.
As the researcher, how can you approach this challenging situation with compassion, yet still meet the goal to collect critical safety information helpful to people in the future?
As the sponsor or institution, how can you best support your researchers in handling this possibly charged situation?
Address This Scenario in the Protocol
As a protocol is being designed, decide if it will be important to follow any incidental pregnancies. The protocol should ideally discuss:
- What is your rationale for collection of pregnancy information?
(For example: We plan to follow pregnancies in partners, to help uncover any reproductive risks related to the drug being tested.)
- Do you plan to follow pregnant subjects, pregnant partners of male subjects, or both?
- Are you following just until pregnancy outcome? Or are you collecting post-natal data until the infant is age 3 months, 6 months? Why?
Include Information in the Consent/Authorization Form
An understandable document will support the researchers in obtaining permission from a pregnant partner. Overall, write clearly for the lay reader, avoiding overly technical language or legalistic jargon.
As we discussed in our last post, there are many considerations, including regulatory, when assessing whether pregnant partners are considered research subjects. Regardless of where you land in that debate, Quorum generally recommends providing pregnant partners sufficient information to ensure the collection of information is voluntary.
Often, the easiest way to do this is via a consent form that includes the regulatory elements of consent.
This approach supports the Belmont Report principle of respect for persons
Explain the context
It’s vital to provide the reader enough information so she can make a valid decision. Don’t assume a pregnant partner knows anything about the research.
Explain why the information is being requested and, if applicable, the nature of the drug that was being tested. If an experimental drug was taken by the male partner, include a description of the term “experimental” (for example, “a drug that is being tested and is not approved by the FDA”).
Steer clear of undue influence
You want to encourage the pregnant partner to allow her information to be collected—but to meet the principle of respect for persons, avoid strong-arm tactics. The information may be extremely valuable, but over-emphasis conflicts with regulatory guidance about undue influence and coercion.
Even if the protocol requires a researcher to attempt to collect pregnancy information, a woman may always choose to decline.
The primary risk may be a possible loss of confidentiality. Do not understate this risk, because the probability of a data breach or accidental loss has only increased in recent years.
It’s also relevant to explain any known risks to the pregnancy, embryo or fetus, as well as the possibility of unknown risks.
Avoid therapeutic misconception
The collection of pregnancy information could help others in the future, but it does not offer benefit to the pregnant woman. This activity is not being done to offer a therapeutic benefit.
Also take care to avoid implying any standard pregnancy care will be provided, and consider avoiding the term “pregnancy follow-up,” which could mislead the reader to think the pregnancy is being followed medically. We recommend statements such as:
- “We are asking to collect information about your pregnancy for the research. This will not change your regular pregnancy care. “
- “You should inform your regular care provider that your partner was taking an investigational drug when you got pregnant.”
Following these best practices can help you uphold principles of respect for persons and voluntariness as they relate to collection of incidental pregnancy information. These practices also support clear and compassionate communication during a potentially scary and worrying situation for the pregnant partner.