The right to withdraw: What does it really mean?
Review withdrawal procedures, language in consent
Every study participant has seen some variation of this assurance in informed consent documents: "You are free to participate in this research or to withdraw at any time without penalty or loss of benefits you are entitled to receive."
That notice, and the underlying right to withdraw from research, is required by federal regulations. But what happens at the point when a participant decides to invoke that right? What can and should researchers say to participants about the decision? Is it permissible to ask a departing research subject to submit to some final tests for their own good, or for the good of the study?
Marjorie Speers, PhD, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), says that the regulations are less clear on these questions.
"I would say it's not fully addressed in the federal regulations, so it's an area where it's really important for IRBs and researchers to think through these issues and to make an ethical decision," Speers says.
Elisa Gordon, PhD, MPH, an associate professor of medicine at Alden March Bioethics Institute in Albany, NY, has studied the language of informed consent documents to see how they address the issue of withdrawing from studies. She says that while documents always contain the required statement about a right to withdraw from studies, other important aspects of withdrawal are often left out or vaguely worded.
For example, a review of 114 consent forms from one Midwestern academic center found that 30 forms asked participants to submit to additional activities before withdrawing from a study. Only four forms cited safety as the reason for an additional visit or test.
"The language in the consent forms I saw was really ambiguous," Gordon says. "They said things like, 'we encourage,' 'we recommend,' or 'we expect' something or other. That doesn't say whether someone is required to do it, but it also conveys a kind of power language. A study participant trusts the doctor and will probably want to do what the doctor says, given that ambiguous language.
"People should be told up front, very clearly: You have this right to withdraw, there are risks you should know of, and it would be great if you could come in so that we can make sure the drug testing went safely. Just be transparent about it."
Gordon says investigators may be resistant to the idea of discussing withdrawal in detail in consent forms. "They don't want subjects to have that in mind," she says. "But that just raises the whole point of voluntariness."
Detailing consequences
Federal regulations require that where appropriate an informed consent document must spell out the potential consequences on a patient's health or well-being of withdrawing from a study early.
Gordon says that in her review of consent documents she found none that addressed that issue.
"It's an area where we can make a lot of headway," she says. "We need to state explicitly what the consequences on the patient's health are, if it's the kind of study that's therapeutic and would have some bearing on their health. It's important for the consent form to articulate what the risks of withdrawing are, just as we inform people what the risks of participating are."
Speers notes that the regulations only require this type of disclosure when it's appropriate. In many studies, it wouldn't be necessary to bring it up.
"Say you're doing an hour-long survey and halfway through the survey, the individual says, 'I just don't want to continue.' In that situation, I can't imagine any consequences of discontinuing participation," she says.
"But let's say you're doing a clinical trial, where the individual is scheduled to receive an intervention — whatever it is, standard arm or experimental treatment arm. If they decide to discontinue in the study, there can be consequences," including having to seek the standard treatment from another source or having to be monitored for safety reasons.
"In that case, it would be ethically appropriate and really the obligation of the researcher to spell out the consequences of discontinuing the study," Speers says.
What can we do to keep you in?
Once a person has decided to withdraw from a study, the issue arises of how far investigators can go to try to persuade the subject to reconsider.
Some attempts could be considered benign — helping a subject find child care in order to continue to attend study visits, for example. But others could be seen as coercive.
Gordon says the power differential between a subject and patient makes walking this line particularly tricky.
"Even among those subjects who have high socioeconomic status and high education, it might be hard psychologically to withdraw if someone is trying to sell you to stay in," she says. "I'm cautious and not settled about the issue of people asking, 'What can we do to keep you in?'"
For her own part, when someone wishes to withdraw from her studies, Gordon is careful even when asking the subject's reason for withdrawing.
"On the one hand, I feel comfortable asking [why] for the sake of tracking, so that the study investigators can do a better job in the future with retention," she says. "I'll say, 'I track the reasons people don't want to participate, may I ask you' — I first ask if I can ask — 'what your reasons are?' They have the option to say no, they don't want to respond.
"I try to make it as transparent and open to people as possible."
Speers says it's ethical to ask the participant the reason for withdrawal, because it could be in the best interest of the subject to resolve the issue.
"If it's in a clinical study where there's an intervention, because we don't know the outcome of the study, we also don't know the outcome if someone drops out of the study early," she says. "So if they drop out, we don't have a way to follow them and monitor them. If they stay in the study we have a way to do that.
"It can be in their best interest to potentially stay in the study and [for the researcher to] explore with the individual why they want to drop out in a non-coercive manner."
Gordon and Speers agree that if a subject is determined to leave the study, that right must be respected.
Gordon says subjects should not be asked to participate in additional visits or testing only to aid in the collection of data for the study.
"If somebody says they want to leave, you should let them leave," Gordon says. "If the rationale given for asking people to undergo a further study visit is to collect additional scientific data, that's not ethical."
Speers says such a request could be made, but would have to be handled very carefully, to ensure the subject doesn't feel coerced.
Keeping withdrawal in mind
IRBs should examine protocols with withdrawal issues in mind, say Gordon and Speers.
While it's not possible to anticipate all the reasons a person might want to drop out, Speers says an IRB should ask whether the researcher anticipates an attrition rate, and then discuss the possible consequences of withdrawal for the subjects.
"If there are negative consequences, then those need to be described in the consent process. You would be looking in the protocol for those consequences, some type of harm," she says. "Also, if there need to be procedures in place for terminating or discontinuing in the study, to spell out what those procedures will be."
In the case of unexpected withdrawals, Speers says the investigator should go back to the IRB to seek guidance on how to proceed.
Gordon says IRBs should be particularly rigorous in examining consent forms for withdrawal language.
"I think there should be more attention to any barriers to withdrawal that are in the consent forms — manifested, for example, in that kind of ambiguous language I mentioned."
She says that if study participants are asked in consent forms to undergo further testing or visits after withdrawing, the rationale should be stated clearly.
"I think it requires just a little bit more attentiveness," she says. "I know that's hard in this day and age, where IRB reviews take a long time, but this is an issue that deserves some attention."
Every study participant has seen some variation of this assurance in informed consent documents: "You are free to participate in this research or to withdraw at any time without penalty or loss of benefits you are entitled to receive."You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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