Constitutional Confidentiality

Federal Certificates of Confidentiality (“Certificates”) protect sensitive information about human research subjects from disclosure and use in judicial, administrative, and legislative proceedings at both the state and federal levels. When they were first authorized by Congress in the 1970s, Certificates covered sensitive information collected in research about drug addiction use. Today, however, they extend to virtually all personal information gathered by biomedical research studies. The broad reach of Certificates, coupled with their power to override state subpoenas and warrants issued in the context of law enforcement, abortion regulation, and other police powers typically under state control, beg the question whether Certificates are constitutional. This Article, for the first time, examines the fundamental constitutional underpinnings of Certificates and situates them within the context of federal statutory privilege law. In so doing, it makes several contributions to the existing literature. First, after a brief background about Certificates and other congressional action relating to biomedical research, this Article argues that the Certificate statute creates a federal statutory privilege. To date, the language of privilege has been wholly absent from discussions of Certificates and their reach. Yet understanding the Certificate as a privilege provides well understood nomenclature and legal principles for applying the Certificate statute. Second, this Article locates the primary constitutional authority undergirding the Certificate statute in the Commerce Clause. Third, this Article argues that Congress’s power to tax and spend provides further constitutional grounding for Certificates, at least with respect to federally-funded researchers and institutions. For both bases of constitutional authority, this Article maps new territory, yielding clarity where there has previously been uncertainty. Fourth, this Article brings together constitutional doctrines limiting both congressional power and evidentiary privileges to illuminate how these doctrines may require Certificate protections to give way in exceptional cases. In so doing, it bridges traditional constitutional law and evidence law, reaping insights from their intersection from which scholars in both fields may benefit. Finally, this Article considers the implications of this constitutional analysis not only on Certificates, but also on congressional action aimed at regulating human subjects research more generally and on the law surrounding federal statutory privileges

Prospective Biorepository Participants' Perspectives on Access to Research Results

Disclosure of individual research results to research participants has been the subject of professional guidelines as well as scholarly commentary, yet controversy remains. To gather data on participant perspectives, we interviewed 40 individuals from the Durham, North Carolina area about a biorepository consent form and conducted an in-depth analysis of responses to a series of questions concerning access to research results. Cross-cutting themes emerged about (1) the nature of research; (2) the nature of research results; (3) expectations concerning access to research results; and (4) practical issues in providing access to research results. Our findings highlight the importance for sound policy development of soliciting stakeholder input, and exploring the complexities behind their evaluations

Developing a Simplified Consent Form for Biobanking

BACKGROUND: Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. METHODOLOGY/PRINCIPAL FINDINGS: We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. CONCLUSIONS: Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively

Am I a control?: Genotype-driven research recruitment and self-understandings of study participants

Genotype-driven research recruitment complicates traditional study roles and may leave those recruited worried about unwelcome surprises from their DNA. This study investigated the ways that individuals experience genotype-driven recruitment, and conceptualize their roles as research participants

Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice

The federal Certificate of Confidentiality plays an important role in research on sensitive topics by authorizing researchers to refuse to disclose identifiable research data in response to subpoenas in any legal setting. However, there is little known about how effective Certificates are in practice. This article draws on our legal and empirical research on this topic to fill this information gap. It includes a description of the purpose of Certificates, their legislative and regulatory history, and a summary of the few reported and unreported cases that have dealt with Certificates. In addition, we outline other statutory confidentiality protections, compare them to the Certificate\u27s protections, and analyze some of the vulnerabilities of a Certificate\u27s protections. This analysis allows us to make specific recommendations for strengthening the protections afforded to research data

The Meaning of Genetic Research Results: Reflections from Individuals with and without a Known Genetic Disorder

In the debate about whether to return individual genetic results to research participants, consideration of the nature of results has taken precedence over contextual factors associated with different study designs and populations. We conducted in-depth interviews with 24 individuals who participated in a genotype-driven study of cystic fibrosis: 9 of the individuals had cystic fibrosis, 15 had participated as healthy volunteers, and all had gene variants of interest to the researchers. These interviews revealed that the two groups had different ideas about the meaningfulness of genetic results. Our findings point to the importance of understanding research context, such as participants’ relationship with the researcher and whether they have the disease condition under study, when considering whether to return individual results

Recommendations for ethical approaches to genotype-driven research recruitment

Recruiting research participants based on genetic information generated about them in a prior study is a potentially powerful way to study the functional significance of human genetic variation. However, it also presents significant ethical challenges that, to date, have received only minimal consideration. We convened a multi-disciplinary workshop to discuss key issues relevant to the conduct and oversight of genotype-driven recruitment and to translate those considerations into practical policy recommendations. Workshop participants were invited from around the U.S., and included genomic researchers and study coordinators, research participants, clinicians, bioethics scholars, experts in human research protections, and government representatives. Discussion was directed by experienced facilitators and informed by empirical data collected in a national survey of IRB chairs and in-depth interviews with research participants in studies where genotype-driven recontact occurred. A high degree of consensus was attained on the resulting 7 recommendations, which cover informed consent disclosures and choices, the process for how and by whom participants are recontacted, the disclosure of individual genetic research results, and the importance of tailoring approaches based on specific contextual factors. These recommendations are intended to represent a balanced approach—protecting research participants, yet avoiding overly restrictive policies that hinder advancement on important scientific questions

A survey of practices for the use of electronic health records to support research recruitment

Electronic health records (EHRs) provide great promise for identifying cohorts and enhancing research recruitment. Such approaches are sorely needed, but there are few descriptions in the literature of prevailing practices to guide their use. A multidisciplinary workgroup was formed to examine current practices in the use of EHRs in recruitment and to propose future directions. The group surveyed consortium members regarding current practices. Over 98% of the Clinical and Translational Science Award Consortium responded to the survey. Brokered and self-service data warehouse access are in early or full operation at 94% and 92% of institutions, respectively, whereas, EHR alerts to providers and to research teams are at 45% and 48%, respectively, and use of patient portals for research is at 20%. However, these percentages increase significantly to 88% and above if planning and exploratory work were considered cumulatively. For most approaches, implementation reflected perceived demand. Regulatory and workflow processes were similarly varied, and many respondents described substantive restrictions arising from logistical constraints and limitations on collaboration and data sharing. Survey results reflect wide variation in implementation and approach, and point to strong need for comparative research and development of best practices to protect patients and facilitate interinstitutional collaboration and multisite research

Research Participants' Perspectives on Genotype-Driven Research Recruitment

Genotype-Driven Recruitment is a potentially powerful approach for studying human genetic variation but presents ethical challenges. We conducted in-depth interviews with research participants in six studies where such recruitment occurred. Nearly all responded favorably to the acceptability of recontact for research recruitment, and genotype-driven recruitment was viewed as a positive sign of scientific advancement. Reactions to questions about the disclosure of individual genetic research results varied. Common themes included explaining the purpose of recontact, informing decisions about further participation, reciprocity, “information is valuable,” and the possibility of benefit, as well as concerns about undue distress and misunderstanding. Our findings suggest contact about additional research may be least concerning if it involves a known element (e.g., trusted researchers). Also, for genotype-driven recruitment, it may be appropriate to set a lower bar for disclosure of individual results than the clinical utility threshold recommended more generally