Certificates Of Confidentiality Research Articles

Certificates of confidentiality: privileging research data.

With the Supreme Court's decision in Dobbs, reproductive research now joins other sensitive research topics that present legal risks to research participants, underscoring the role of Certificates in protecting them. Yet, stakeholders question whether Certificates will hold up in court. In this article, we describe the essential arguments supporting Congress's regulation of biomedical research and, thus, Certificates, under its authority to regulate interstate commerce. Our analysis should reassure researchers and Institutional review boards who rely on Certificates to protect the confidentiality of research participants' data. We conclude with recommendations for stakeholders based on our analysis.

Certificates of Confidentiality: Mind the Gap.

Certificates of Confidentiality: Mind the Gap.

Certificates of confidentiality and unexpected complications for pragmatic clinical trials.

IntroductionThe need to protect the confidentiality of research data has long been recognized. One means to help protect research data from use in civil or criminal matters in the United States is a Certificate of Confidentiality (CoC). Until recently, investigators applied for a CoC when conducting research that was sensitive, stigmatizing or where the disclosure of private information could possibly result in civil or criminal liability. However, effective October 1, 2017, CoCs are automatically issued for much research supported by the National Institutes of Health (NIH). While automatic issuance reduces administrative burden, it also poses some surprising unanticipated challenges for research in general and pragmatic clinical trials (PCTs) in particular, which are key elements of learning health systems.MethodsWe reviewed the new policy on CoCs to identify and analyze issues related to it that are potentially problematic for PCTs.ResultsWe identified three relevant issues: (1) whether the EHR may be populated with research data that may be sensitive or stigmatizing without explicit consent from subjects; (2) incomplete protections for sensitive data in the EHR; and (3) requirements for notifying subjects about the CoC provisions.ConclusionFormal guidance from the NIH is needed to address the application of CoCs to the setting of PCTs. In the meantime, it is essential for researchers designing and conducting PCTs, as well as health care systems in which this research is conducted, to be aware of the nuances inherent in CoCs so they can best adhere to their legal obligations regarding them. In the absence of guidance, special attention should be paid to pragmatic research that populates the electronic health record with research data as well as research conducted without explicit consent. Given the large amount of pragmatic research precipitated by the Coronavirus Disease 2019 pandemic, which has been accompanied by major efforts to share data, the need for such guidance is especially urgent.

Genomic databases, subpoenas, and Certificates of Confidentiality

Genomic databases, subpoenas, and Certificates of Confidentiality

Substance use disorders in pregnancy: clinical, ethical, and research imperatives of the opioid epidemic: a report of a joint workshop of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, and American Society of Addiction Medicine

Substance use disorders in pregnancy: clinical, ethical, and research imperatives of the opioid epidemic: a report of a joint workshop of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, and American Society of Addiction Medicine

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's protections, and analyze some of the vulnerabilities of a Certificate's protections. This analysis allows us to make specific recommendations for strengthening the protections afforded to research data.

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

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

Certificates of Confidentiality: Legal Counsels' Experiences with and Perspectives on Legal Demands for Research Data

The certificate of confidentiality (Certificate) is an important tool for protecting identifiable, sensitive human subjects research data in the United States. However, little is known about the Certificate's effectiveness in protecting identifiable data. We interviewed 24 legal counsel representing U.S. research institutions about their experiences with legal demands for research data. Our respondents reported few, if any, legal demands over the course of their tenure, but two-thirds had experience with legal demands for data protected by a Certificate. They reported such demands often were resolved without disclosure of identifiable research data, typically without court intervention. While our respondents reported similar success protecting identifiable data in court, they often did not rely on the Certificate to do so.

Certificates of Confidentiality and the Marshfield Clinic's Personalized Medicine Research Project

Enrollment in research studies is often limited by the fear that one’s personal information cannot be kept private. One way researchers can address this is by obtaining a certificate of confidentiality (CoC) for their study. This article briefly reviews what a certificate of confidentiality is, how to obtain one, and the Marshfield Clinic’s experience in recruiting for the Personalized Medicine Research Project.

Ethical conduct in intimate partner violence research: Challenges and strategies

Intimate partner violence (IPV) research has expanded dramatically in the past 2 decades. However, updated ethical guidelines to protect the safety and autonomy of research participants, study data, and the research team are still lacking in this evolving area of research. This article presents general concepts in research ethics and the specific challenges and strategies for IPV research related to recruitment and retention, maintenance of women's safety, privacy, and confidentiality, and their voluntary participation as well as assessment of benefits and risks, strategies to minimize risk, the Certificates of Confidentiality, and training of the research team. This area of nursing research is critical for developing practice guidelines and improving the health and quality of life of abused women.

Obtaining an NIH Certificate of Confidentiality to Protect the Identities of Research Participants

Certificates of Confidentiality (CoC) can be obtained from the National Institutes of Health (NIH) to protect researchers from forced disclosure of their participants’ personally identifiable information. We recently applied for an NIH CoC and it was approved. In this article, we describe an NIH CoC and why you might want one. Then we share our experiences in getting one, including one unexpected snag, and what we learned about CoCs that surprised us.

Certificates Should Be Retired

In their thoughtful Policy Forum on research ethics, “Certificates of Confidentiality and compelled disclosure of data” (14 November 2008, p. [1054][1]), L. M. Beskow, L. Dame, and E. J. Costello describe a case where research records, despite having this Certificate, were not fully protected from a court-ordered subpoena. Considering this case and our Institutional Review Board (IRB) experiences, we wonder whether the Certificate, unevenly required by IRBs and time-consuming to obtain, provides any additional, substantive protections to research subjects. Currently, Informed Consent and HIPAA authorization documents explicitly state how research data will be secured, with whom data may be shared, and what monitoring agencies may have access. Furthermore, consent documents often state which information (e.g., child or elder abuse) will be disclosed to authorities. These explicit data-sharing permissions and protections appropriately cover all research records, regardless of their supposed “sensitive” or “nonsensitive” content. Obtaining a Certificate of Confidentiality from NIH places burdens on investigators and lengthens informed consent documents already laden with confusing legal language. If time is critical, investigators may choose to remove sensitive questions or instruments to achieve more rapid IRB approval. Hence, the value of the research may be compromised. With the goals of enhancing subject recruitment and obtaining honest research data on sensitive topics, one must weigh the purported benefits of the Certificate against their potential impedance of established legal and judicial system processes. As imperfect as those processes may be, we believe that the effectiveness of legal arguments and the privacy rights provided to all research subjects by covered entities should govern final judicial decisions, and not a Certificate selectively issued by NIH. [1]: /lookup/doi/10.1126/science.1164100

Certificates Should Be Strengthened

As attorneys practicing in the area of bioethics, and members of the RAND Corporation's Institutional Review Board, we read with interest the Policy Forum by L. M. Beskow et al. (“Certificates of Confidentiality and compelled disclosure of data,” 14 November 2008, p. 1054). In our view, however, the authors overstated the implications of a recent appellate case involving Duke University Health System (DUHS), State v. Bradley, 179 N.C. App. 551 (2006). On the basis of Bradley, the authors concluded that “the protection Certificates [of Confidentiality] offer [to research data] is uncertain” and further suggest that “caution is warranted when representing the impact of a Certificate to potential research participants.” We disagree.

IRB Chairs' Perspectives on Genomics Research Involving Stored Biological Materials: Ethical Concerns and Proposed Solutions

WE EVALUATED 55 IRB CHAIRS' perspectives on ethical issues in a hypothetical study involving mental health-related genomics research using stored specimens to identify potential barriers and solutions to such research. Most Chairs identified the ethical issues of consent and confidentially as important. The majority of Chairs expressed concern about using materials in new research, especially concerning a mental health condition, that was not discussed in the original consent. Few Chairs considered permissible strategies, such as deidentification and waiver of consent, which could allow the proposed research to go forward without consent. Chairs who reviewed more protocols and had attended conferences on human subjects protection identified more of the salient ethical issues in the scenario. Our study could not determine whether Chairs were not familiar with the strategies of de-identification and waiver of consent, or believed that they did not adequately protect participants who had provided specimens for research. Thus, our findings suggest that investigators and IRBs should consider future use of specimens and obtain appropriate consent before collection of specimens. Furthermore, our findings suggest that IRBs can improve review of genomics research involving stored specimens by redesigning forms to prompt IRB members to consider some strategies, such as de-identification and Certificates of Confidentiality, that are recommended for this type of research and by sending members to conferences on human subjects protections and research ethics.

Certificates of Confidentiality and Compelled Disclosure of Data

Ethical principles and professional codes of conduct require that researchers protect research participants' privacy, as well as the confidentiality of their data (1, 2). Certificates of Confidentiality are intended to help meet these obligations by preventing forced disclosure of identifiable data during legal proceedings (3). A recent case indicates that the protection Certificates offer is uncertain.

Collection, Storage, Retrieval and Distribution of Biological Materials for Research

Collection, Storage, Retrieval and Distribution of Biological Materials for Research

2008 Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research

2008 Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research

Ethical Issues in Couple and Family Research.

Federal regulations, ethical standards, and state laws governing ethics do not adequately address important issues in couple and family research. Including multiple family members, particularly dependent minors, in research requires the special application of fundamental ethical issues, such as confidentiality, privacy, and informed consent. The sensitive, commingled nature of couple and family information necessitates clear policies about data ownership and disclosure. Researchers need to have respect for the family as a unit and to evaluate benefits versus harms for the family as well as for individuals. This article highlights areas of potential concern and ambiguity related to abuse reporting and Certificates of Confidentiality and also addresses ethical issues with observational data, intervention studies, longitudinal designs, and computer-assisted research.

Certificates of confidentiality in research: rationale and usage.

Certificates of confidentiality (COCs) are a tool to protect researchers from being compelled to release identifying information about their subjects. Whereas institutional review board (IRB) review and informed consent procedures are mandatory tools to protect human subjects, COCs are voluntary. There are limited data about who procures COCs and why, and whether they are useful. Three Institutes of the National Institutes of Health (NIH) provided data on 114 research projects that had received COCs. Eighty-three researchers had procured a single COC and 11 researchers had procured 31 COCs. One hundred and four (91%) of the COCs were obtained by researchers at academic sites, and 17 institutions collectively accounted for 82 COCs. The most commonly cited sources of information about COCs came from colleagues (n = 18, 35%) and previous experience (n = 17, 33%). The most common reasons for procuring a COC were that the research involved genetics (n = 28, 54%), the research could lead to social stigmatization or discrimination (n = 22, 42%), or the research could damage an individual's financial standing, employability, or reputation (n = 21, 40%). These findings show that COCs are often congregated within institutions and by particular individuals. This may be because others are unaware of COCs or because others do not believe they are necessary or useful.

Certificates of Confidentiality in Research: Rationale and Usage

Certificates of confidentiality (COCs) are a tool to protect researchers from being compelled to release identifying information about their subjects. Whereas institutional review board (IRB) review and informed consent procedures are mandatory tools to protect human subjects, COCs are voluntary. There are limited data about who procures COCs and why, and whether they are useful. Three Institutes of the National Institutes of Health (NIH) provided data on 114 research projects that had received COCs. Eighty-three researchers had procured a single COC and 11 researchers had procured 31 COCs. One hundred and four (91%) of the COCs were obtained by researchers at academic sites, and 17 institutions collectively accounted for 82 COCs. The most commonly cited sources of information about COCs came from colleagues (n = 18, 35%) and previous experience (n = 17, 33%). The most common reasons for procuring a COC were that the research involved genetics (n = 28, 54%), the research could lead to social stigmatization or discrimination (n = 22, 42%), or the research could damage an individual's financial standing, employability, or reputation (n = 21, 40%). These findings show that COCs are often congregated within institutions and by particular individuals. This may be because others are unaware of COCs or because others do not believe they are necessary or useful.