Uncertainties on Future Use of Study Participants’ Data
Patients may agree to donate a biosample (e.g., blood, urine, saliva, or tissue from biopsies or surgeries) for their physician’s clinical study, but potential future uses of that sample raise complex ethical issues.
Under the Common Rule, investigators can obtain broad consent for future use of identifiable samples, notes Sharona Hoffman, JD, co-director of the Law-Medicine Center at Case Western Reserve University in Cleveland. Therefore, if a patient whose sample will be used for a colon cancer study provides broad consent for the future use of the sample, a different researcher could use the sample for an Alzheimer’s disease study without notifying the patient.
“One problem is a lot of study participants may provide broad consent but not understand what that really means, and they won’t think to ask probing questions about it,” Hoffman says.
The average patient has no medical, academic, or scientific background. Average patients are unlikely to ask questions such as “What types of studies might my sample be used for in the future?” or “How long will the sample be retained?” Thus, for researchers, what is there to say about it? “Do you raise that concern for patients very explicitly, or more subtly?” Hoffman asks.
It might be better if investigators ask patients to agree for a sample to be used for a specific study and then for that sample to be destroyed. Sometimes, researchers want to keep the sample indefinitely, but that conversation is more complicated. “You don’t know what technologies or capabilities will develop,” Hoffman notes.
No one can really predict how others will use the sample in the future. “The fact that samples will be retained for future studies does have to be disclosed in the consent documents, but those are typically really long. Chances are the patient is not reading it carefully,” Hoffman says.
Some patients might not want their sample used for certain kinds of research, such as studies on reproductive technology or on genes that are associated with violence. “If something is being done that is controversial, it should absolutely be discussed with the patient,” Hoffman asserts.
If the patient objects for religious or other reasons or because of concerns about stigmatization, the researcher should address that concern.
“Doctors don’t want to discuss things in scary ways that are going to turn off prospective research participants. Not all doctors are highly skilled in communication or psychology, and they have limited time to do one-on-one discussions,” Hoffman observes.
Often, nurses or research staff are the ones who engage in consent discussions, closely following scripted language.
Recontacting every person who donated a sample is not feasible. “People might suggest we contact everyone anytime the sample is used for a new study instead of obtaining broad consent. But if it’s 1,000 people, and many of them have moved, you can’t do it,” Hoffman says.
Since samples often are de-identified, investigators cannot know the patient’s identity. “Research with de-identified samples is not covered by the Common Rule, so no consent needs to be obtained for any research with those samples,” Hoffman explains.
If the sample cannot be connected with the patient, investigators never have to obtain permission from patients, regardless of the nature of the project. If researchers need to ask questions about the adequacy of broad consent or de-identification, they can refer to the IRB for consultation.
“While doing research without specific consent from patients might seem distasteful, it is vitally important to facilitate research that can lead to medical advances that will benefit all of us,” Hoffman says.
Some researchers seek explicit consent. This means participants’ data are used for a specific study. “This model differs from broad consent, which permits researchers to use data for future, unspecific purposes and is often pursued in the context of biobank research,” says Vasiliki Nataly Rahimzadeh, PhD, a postdoctoral fellow at Stanford Center for Biomedical Ethics.
Generally, the informed consent process needs improvement, particularly when it comes to explaining to participants what data will be used and how, according to Rahimzadeh.
“Responsible data-sharing rests on making quality data accessible to authorized researchers to meaningfully advance science while respecting participant values,” she says.
Participants may perceive some types of data as more sensitive than others, such as genomic information. “To enhance transparency, there have been proposals, at least among some teaching hospitals, to notify patients that their data may be used for research,” Rahimzadeh says.
The concept of a learning health system depends on treating the patient encounter as an opportunity to improve care delivery through research. “Innovations in health information exchange platforms using blockchain technology, for example, may soon enable participants to exercise greater control over the data they share for research that advances their values and interests,” Rahimzadeh predicts.
Rebecca D. Pentz, PhD, professor of research ethics at Winship Cancer Institute at Emory School of Medicine in Atlanta, makes it clear to participants that no research on their samples can be conducted without IRB approval.
“Explaining the regulatory process that makes sure only ethical research is conducted is important,” Pentz says. For example, research using any personal identifiers must justify the use and explain in detail how the information will be protected.
Pentz and colleagues recently explored whether face-to-face or electronic informed consent was more effective for participants in biobank research.1 They analyzed 501 patients at two U.S. biobanks, finding no differences in understanding between the two methods.
Electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. Face-to-face consent may lead to better understanding and higher enrollment of Hispanic patients and those of lower socioeconomic status. Researchers should consider maintaining a face-to-face consent process to better address the needs of some populations.
“In all cases, the consent should be conducted by a well-trained person who will interact with the potential participant respectfully and ask for any concerns that person may have. Then, address each concern,” Pentz says.
Some study participants worry genetic information might be used in a way that would stigmatize a racial or ethnic group. “We recommend being up front about past research abuses in certain communities and the protections we now have,” Pentz says. “With the new awareness of the importance of diversity, we are now even more careful. Journals are more careful about publishing discriminatory articles.”
Other candidates might ask questions about sharing samples with other countries. “During informed consent, the researchers should be up front and transparent about whom will have access to the biorepository’s samples and data,” Pentz says.
Specifically, researchers should disclose if the samples will be shared internationally, which countries will have access, and if samples will be shared with for-profit companies.
“If none of these are true, it can simply be stated that the samples will be shared within the institution and ... with other academic health centers,” Pentz says.
Recruiters should convey how important biosamples are in the search for new treatments to cure diseases. In two previous studies, Pentz and colleagues found most potential participants were quite willing to participate.2,3 This was true even at an inner city hospital whose patients were the underserved.
“We make it clear that you can always opt out at any time, though samples already given to researchers cannot be returned,” Pentz says.
Jeffrey R. Botkin, MD, MPH, says his impression is research participants do not ask questions about this issue because most people do not understand what research entails.
“We all know that the informed consent process is largely ineffectual in promoting a thorough understanding of the facts and implications of the proposed research,” says Botkin, professor emeritus of pediatrics at the University of Utah S.J. Quinney College of Law.
Most participants do not know enough about secondary uses to ask questions. In a focus group, Botkin and colleagues found the lay public does not know clinical data or tissues can be used for research without their permission.4 However, when the process and protections were discussed, most participants were comfortable with the system and supported an opt-out approach to consent.
“It would be ideal to have a more effective consent process to more fully inform participants about this and other issues,” Botkin offers.
Sometimes, candidates want to know if a company will make a profit off their data. The answer probably is yes.
“This is a turnoff for many potential participants. Yet we all know pharmaceutical companies, for example, expect to make a profit,” says Elizabeth Eisenhauer, PhD, RN, assistant professor at the Oakland University School of Nursing in Rochester, MI.
Other candidates ask if their sample could be used for cloning research. “However, I’d say the majority of potential participants simply don’t have sufficient genetic or scientific literacy to ask these questions at all,” Eisenhauer says.
That means people are making important decisions without sufficient knowledge. “In other words, they are making uninformed decisions. It is not ethical for researchers to obtain consent from individuals who don’t understand what they are agreeing to,” Eisenhauer says.
Eisenhauer sees a need for legislation that requires researchers to provide explicit examples during the informed consent process of the types of research that may be conducted with personal information or biospecimens.
“We need not just beneficial, life-saving research examples, but examples of controversial research, too,” Eisenhauer says.
This information should be provided even if the candidate does not know to ask for it. A tiered approach to informed consent is a possible solution. For example, individuals may agree to provide a biospecimen, but not provide access to their medical records. “The current status of informed consent for biospecimen and data research is greatly flawed,” Eisenhauer says.
Currently, if data or biospecimen are “nonidentified,” it may not even be considered human subjects research, even though the data or biospecimen certainly came from a human. In the case of biospecimen research, deleting someone’s name may not remove the feeling of complicity in various types of biomedical research some find unethical.
“Just because a researcher removes a name from a biospecimen doesn’t make it OK for them to do whatever they please with it,” Eisenhauer concludes.
- Simon CM, Wang K, Shinkunas LA, et al. Communicating with diverse patients about participating in a biobank: A randomized multisite study comparing electronic and face-to-face informed consent processes. J Empir Res Hum Res Ethics 2022;17:144-166.
- Warner TD, Weil CJ, Andry C, et al. Broad consent for research on biospecimens: The views of actual donors at four U.S. medical centers. J Empir Res Hum Res Ethics 2018;13:115-124.
- Pentz RD, Billot L, Wendler D. Research on stored biological samples: Views of African American and White American cancer patients. Am J Med Genet A 2006;140:733-739.
- Botkin JR, Rothwell E, Anderson R, et al. Public attitudes regarding the use of electronic health information and residual clinical tissues for research. J Community Genet 2014;5:205-213.
Generally, the informed consent process needs improvement, particularly when it comes to explaining to participants what data will be used and how. Responsible data-sharing rests on making quality data accessible to authorized researchers to meaningfully advance science while respecting participant values.
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