Vardit Ravitsky on Whether Research Participants Should Know Their Results

Fast Moving Fronts Commentary, March 2011

Vardit Ravitsky

Article: Disclosing individual genetic results to research participants


Authors: Ravitsky, V; Wilfond, BS
Journal: AM J BIOETH, 6 (6): 8-17, NOV-DEC 2006
Addresses: NIH, Dept Clin Bioeth, Ctr Clin, Bethesda, MD USA.
NIH, Dept Clin Bioeth, Ctr Clin, Bethesda, MD USA.
Univ Penn, Philadelphia, PA 19104 USA.
NHGRI, Social & Behva Res Branch, NIH, Bethesda, MD 20892 USA.
Univ Washington, Seattle, WA 98195 USA.

Vardit Ravitsky talks with ScienceWatch.com and answers a few questions about this month's Fast Moving Fronts paper in the field of Social Sciences, general.


SW: Why do you think your paper is highly cited?

Our paper addresses a question that is challenging and has important social and ethical implications: when should researchers disclose individual results to participants in genetic research? Traditionally, researchers were not used to sharing individual findings with participants for two main reasons. First, in the context of research the significance of such findings is often not clear yet. Second, researchers did not see disclosure as a part of their role, since research is supposed to produce "generalizable knowledge," not to address the needs of individuals.

Our paper addresses the emerging issue of individual genetic results that may have some utility or some meaning for participants, even in the preliminary stage of research. For example, should researchers share with participants their individual results in a study that gradually establishes an association between a certain mutation and an increased risk for a certain disease?

The paper is timely because the development of ethically justified policies to address such disclosure is becoming more pressing for a number of reasons. First, genetic research is increasingly prevalent as the focus is shifting from studying rare diseases in isolated families to determining the contribution of genetics to common disorders such as cancer and heart disease. Second, the probabilistic character of genetic information and the pleiotropic nature of genes (a single gene influences a few phenotypic traits) make accurate interpretation and communication particularly challenging. Third, the potential impact of genetic information on family relationships, reproduction, and personal identity highlights the subjective value of genetic results and may further complicate their communication.

"The approach that the research community takes towards the disclosure of individual results to research participants will therefore become increasingly important and will affect many people in very significant ways."

In the paper we propose an ethical framework that can help researchers determine which results to offer in which study. It can also help them design their studies in a way that foresees and addresses future issues. Our framework allows researchers to inform participants in advance regarding their disclosure-approach and to learn about participants' preferences. This is important in light of the fact that currently the practices of researchers vary greatly and often such issues have to be addressed in an ad hoc fashion after the study has already begun and without the prior informed consent of participants.

SW: Does it describe a new discovery, methodology, or synthesis of knowledge?

The paper describes a novel approach to a highly complex issue, an approach that is comprehensive, balanced, and nuanced. It is based on the ethical principles of beneficence, respect, reciprocity, and justice and allows researchers to take many considerations into account and analyze on a case-to-case basis how to address different types of results in the contexts of different studies.

SW: Would you summarize the significance of your paper in layman's terms?

The importance of the approach we are proposing in this paper is in the fact that it is sensitive to the nuances of each case and to the context of each study. We called it a "result-evaluation approach" because it analyzes the nature of each result and puts it in the broader context of a specific study in order to determine whether or not it should be routinely offered to participants.

First, we propose to evaluate the analytic validity (is the result reliable) and the clinical utility (can it be used to improve the participant's well-being) of a specific result. This means that even within the same study, different results may require different disclosure-decisions. We argue that reliable results that have clear clinical utility should be offered to participants routinely.

Next, we propose to assess the possible personal meaning that a result may have for participants because genetic results may have the potential to impact participants' relationships or personal identity. For example, issues related to lineage can arise in family studies, issues related to ethnic or cultural identity can arise in ancestry studies, and issues related to personal identity can arise in studies about genetic associations of behavioral traits that are potentially modifiable, such as obesity or addiction.

"Our paper addresses a question that is challenging and has important social and ethical implications: when should researchers disclose individual results to participants in genetic research?"

We also propose to assess the researchers' capabilities for appropriate disclosure (do they have the necessary skills or the budget to hire a genetic counselor), the participants' alternative access to the result (can they be referred to a clinical lab to obtain the same result), and their relationship with the researchers (when the relationship is long-term and intense, reciprocity may justify a bigger investment on the side of researchers). This analysis shows that the same result may require different disclosure-decisions in different contexts.

SW: How did you become involved in this research, and how would you describe the particular challenges, setbacks, and successes that you've encountered along the way?

This research was conducted as a part of my post-doc fellowship at the National Human Genome Research Institute (at the National Institutes of Health). Benjamin Wilfond and I worked on this paper while consulting with numerous genetic researchers, clinicians, and bioethicists. The main challenge was probably bridging the "cultural gap" between the scientists and their pragmatic concerns regarding the feasibility of the research and our ethical concerns which focused on the importance of respecting the rights of research participants.

SW: Where do you see your research leading in the future?

Since the publication of our paper in 2006 much work has been done in this area. I believe that we are definitely heading in the direction of establishing a norm of offering certain individual results to research participants and I believe the approach we proposed contributed to this trend.

SW: Do you foresee any social or political implications for your research?

Absolutely! Genetic research will continue to expand in volume and is likely to produce results that are increasingly relevant to individual's health, well-being, and life plans. The approach that the research community takes towards the disclosure of individual results to research participants will therefore become increasingly important and will affect many people in very significant ways.End

Vardit Ravitsky, Ph.D.
Assistant Professor
Bioethics Programs
Faculty of Medicine
University of Montréal
Montréal, Canada

KEYWORDS: INDIVIDUAL GENETIC RESULTS, RESEARCH PARTICIPANTS, DISCLOSURE, CLINICAL UTILITY, CLINICAL VALIDITY, GENETIC RESEARCH, CORONARY HEART DISEASE, CLINICAL RESEARCH, BREAST CANCER, ALZHEIMERS DISEASE, POPULATION, PRIVACY, CONSENT, TRIAL.

 
 

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