NPRM – blog.Bioethics.gov https://bioethicsarchive.georgetown.edu/pcsbi/blog The blog of the 2009 - 2017 Presidential Commission for the Study of Bioethical Issues Mon, 09 Jan 2017 23:23:29 +0000 en-US hourly 1 Looking Back at the Bioethics Commission’s Blog https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/12/05/looking-back-at-the-bioethics-commissions-blog/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/12/05/looking-back-at-the-bioethics-commissions-blog/#respond Mon, 05 Dec 2016 16:00:04 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=2125 Throughout its tenure, the Bioethics Commission has maintained an active digital presence to connect with a global audience. A major component of this has been through its blog. This final blog post reflects on the role the blog has played in disseminating the Bioethics Commission’s work.first-blog

Former Bioethics Commission Executive Director Valerie Bonham launched the commission’s blog on November 15, 2010, announcing that the staff would be liveblogging during Meeting Three in Atlanta. From that meeting onward, Bioethics Commission staff continued to blog live from the Bioethics Commission’s meetings, held throughout the country in cities including Washington DC, Philadelphia, Salt Lake City, San Francisco, Chicago, and Boston. Meeting posts highlighted salient points of discussion as they occurred during the public meetings. For example, during Meeting Three, a blog post outlined the members’ deliberations regarding the risks and benefits of synthetic biology. During Meeting Eighteen, which focused on ethical issues in neuroscience, a blog post highlighted some of the discussion about the ethical challenges in neuroscience research. The Bioethics Commission also used blog posts to distill complex topics that arose during meetings. During Meeting Twelve, which focused on pediatric medical countermeasure research, a blog post presented a simplified structure of some of the federal regulations concerning pediatric research.

The commission’s blog also highlighted and explained the impact of the commission’s work. For example, during the commission’s tenure, a notice of proposed rulemaking (NPRM) to revise the Common Rule—the regulations that govern the ethical conduct of federally supported human subjects research—was published in the Federal Register on September 8, 2015. Elements of the commission’s work were included in this notice. In September and October 2015, the Bioethics Commission released a series of blog posts that described some of the relevant inclusions in the NPRM, and explained their significance.

The Bioethics Commission also used the blog to share its outreach activities and initiatives with a broad readership. For example, when Bioethics Commission staff attended the annual meeting of the American Society of Bioethics and Humanities in October 2015, a blog post highlighted the commission’s outreach efforts, and included answers to frequently asked questions that staff members fielded while at the conference. When the Bioethics Commission presented at the White House BRAIN conference, a blog post shared Executive Director Lisa M. Lee’s remarks. On June 8, 2016, Col. Nelson Michael gave an interview with the bioethics news site BioEdge, and the Bioethics Commission staff wrote a two-part blog post on some of the issues Col. Michael raised regarding democratic deliberation and ethics education. Blog posts were also written to describe publications in academic journals by Commission members and staff. A blog post shared a commentary written by Bioethics Commission Vice Ch
air Dr. James Wagner, who wrote about the importance of early ethics education.

During its tenure, the Bioethics Commission produced over 65 educational materials, and used the blog to picture1announce the availability of new educational materials, including user guides, primers, classroom discussion guides, and deliberative scenarios. Blog posts also helped outline how to use the educational materials. Blog posts also highlighted topics including innovations in ethics education, and the importance of civic engagement. The Bioethics Commission also used the blog to announce and promote its podcast series Ethically Sound, a 10-episode series that focuses on some of the ethical issues raised in the commission’s reports.
Readers can access previous blog posts, educational materials, the podcast series Ethically Sound, along with all of the Bioethics Commission’s reports and related materials at bioethics.gov. On behalf of the Bioethics Commission, we thank our readers for their continued interest in the work of the commission.

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Modernizing Human Subjects Research Protections: Legally Authorized Representatives and Consent Capacity https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/09/modernizing-human-subjects-research-protections-legally-authorized-representatives-and-consent-capacity/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/09/modernizing-human-subjects-research-protections-legally-authorized-representatives-and-consent-capacity/#respond Fri, 09 Oct 2015 15:07:18 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1730 This is the last installment in a series of blog posts about recent proposed changes to the Common Rule, and how they relate to the work of the Bioethics Commission. The Common Rule currently requires permission from a legally authorized representative (LAR) to enroll participants who lack consent capacity in research. LARs consider and evaluate the merits of research participation on behalf of others—often loved ones—who lack consent capacity.

In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2) the Bioethics Commission noted that the Common Rule does not specify who can serve as an LAR, what kinds of decisions an LAR can make, and what processes and procedures are required to establish an LAR. Rather, it indicates that these decisions be made according to “applicable law,” including state law. However, while some states have laws that outline LARs for clinical care, few states have laws that specifically address LARs for research, leaving researchers and IRBs with uncertainty. In Gray Matters, Vol. 2, the Bioethics Commission recommended that “federal regulatory bodies should establish clear requirements to identify who can serve as legally authorized representatives for individuals with impaired consent capacity to support their responsible inclusion in research.”

The recent notice of proposed rulemaking (NRPM), which proposes revisions to the Common Rule, recognizes this regulatory gap that was highlighted by the Bioethics Commission. It notes that a possible ramification of this gap is that in states without clear laws, enrolling participants with impaired consent capacity could be difficult or impossible. The NPRM proposes a revision to the Common Rule that would permit LAR requirements to meet an accepted common practice standard, such as an established state or local hierarchy. This proposed revision mirrors the Bioethics Commission’s recommendation and its suggestion that federal regulatory bodies could recognize previous efforts on this front, such as the priority list of potential LARs developed in 2009 by the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP).

If the NPRM proposed revisions are implemented, new research regulations will reflect the Bioethics Commission’s recommendation for clarity in LAR requirements. Clear requirements for LARs facilitate the responsible inclusion of participants with impaired consent capacity in research, which is necessary to fulfill the promise of research that might one day ameliorate neurological disorders and psychiatric conditions.

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Modernizing Human Subjects Research Protections: A Plan for Return of Results https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/05/modernizing-human-subjects-research-protections-a-plan-for-return-of-results/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/05/modernizing-human-subjects-research-protections-a-plan-for-return-of-results/#respond Mon, 05 Oct 2015 18:30:08 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1728 The notice of proposed rulemaking (NPRM), issued in the Federal Register on September 8, 2015, proposes revisions to the Common Rule—federal regulations that govern the protection of human subjects in research—including changes to the criteria for institutional review board (IRB) approval of research. This is the next installment in a blog series about those changes and their relationship to the Bioethics Commission’s work on incidental and secondary findings.

Currently, the Common Rule requires IRBs to find that certain criteria have been met in order to approve research. The NPRM proposes an addition that IRBs should evaluate the appropriateness of a plan for returning individual findings discovered during research, when that plan is submitted as part of the protocol. The proposed rulemaking also addresses the potential challenges of returning individual research findings when it is unclear if the findings are clinically valid or actionable, or when the findings might have psychological or social ramifications.

The Bioethics Commission addressed return of individual research results in its December 2013 report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The Bioethics Commission recommended that IRBs review and approve plans for the disclosure and management of incidental findings—a recommendation echoed in the proposed changes to the Common Rule. The Bioethics Commission stressed the importance of this plan, recommending both that researchers develop a plan for managing incidental and secondary findings and that, during the informed consent process, researchers clearly communicate their plan to participants.

The NPRM cites to the Bioethics Commission’s report, recognizing the importance of the issue of return of individual research results, and the challenges highlighted by Anticipate and Communicate. The challenge of incidental findings and returning individual results in a research context is a perennial one for IRBs and researchers, and due to more advanced technologies and faster and deeper data analysis, the issue is growing. Anticipate and Communicate addresses these challenges head-on, and the Bioethics Commission is pleased to see that federal research regulations are evolving to address them as well.

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Modernizing Human Subjects Research Protections: Changing the Landscape of Biospecimen Research https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/01/modernizing-human-subjects-research-protections-changing-the-landscape-of-biospecimen-research/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/01/modernizing-human-subjects-research-protections-changing-the-landscape-of-biospecimen-research/#respond Thu, 01 Oct 2015 17:43:24 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1726 In this fourth post in a new blog series, we zoom in on changes to the Common Rule—proposed in the notice of proposed rulemaking (NPRM) released earlier this month—that would alter oversight processes for biospecimen research.

In its current form, the Common Rule contains a regulatory gap, recognized throughout the Bioethics Commission’s work. Today, when biospecimens are collected for research purposes, their collection and associated analyses is considered human subjects research and are subject to IRB oversight, informed consent, and other protections required by the Common Rule. However, when biospecimens are collected for clinical purposes, but subsequently used for research, that research is not considered human subjects research under the Common Rule if they are stripped of traditional identifiers. The NPRM proposes changing that.

Over the past 3 years, technology has advanced rapidly, such that it is now possible to identify the donors of biospecimens, even when samples are stripped of traditionally recognized identifiers. As a result, the deidentification process no longer sufficiently protects biospecimen donors from privacy and security risks. In Privacy and Progress in Whole Genome Sequencing, the Bioethics Commission urged that informed consent be obtained for any and all genetic research, regardless of where or why the data were obtained. The NPRM echoes this suggestion, by proposing that the use of biospecimens in research, whether obtained in the context of a study, in the clinic, or any other setting, be considered human subjects research under the Common Rule.

The NPRM strikes a balance for this subsequent data use, allowing for broad initial consent for future research when data are collected for a non-research purpose—a path forward that is both practical and ethically sound, as recognized by the Bioethics Commission in Privacy and Progress.

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Modernizing Human Subjects Research Protections: Informed Consent for Genetic Research https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/24/modernizing-human-subjects-research-protections-informed-consent-for-genetic-research/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/24/modernizing-human-subjects-research-protections-informed-consent-for-genetic-research/#respond Thu, 24 Sep 2015 14:23:35 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1722 This is the third installment of a new blog series—Modernizing Human Subject Research Protections—taking a closer look at the recent notice of proposed rulemaking (NPRM) that suggests revisions to the Common Rule governing federally funded human subjects research. The NPRM draws on the work of the Bioethics Commission, and its ethical underpinnings mirror the analysis used by the Commission in many of its reports.

In its 2012 report, Privacy and Progress in Whole Genome Sequencing, the Bioethics Commission examined the ethics of large-scale genetic research, and made recommendations about how to reconcile the drive to compile large data sets with the imperative to protect the security of donors’ data. Privacy and Progress examined the informed consent process in depth, explaining that informed consent can be more difficult to obtain for genetic research than for other kinds of studies. First, rather than presenting a risk of physical harm, genetic research can involve informational and privacy risks that can be harder to quantify. And second, much of the genetic research that is currently conducted uses samples and data that were collected for other purposes, such as during a clinical encounter or previous research.

Despite these challenges, the Commission emphasized the importance of obtaining fully informed consent from all participants. Being asked to provide informed consent about the use of their data, the Commission argued, conveys respect to participants, separate and apart from their interest in preventing the unauthorized use or disclosure of their data. In other words—there is value to informed consent in and of itself, as it respects autonomy and personhood.

The NPRM reiterates this ethical analysis as a justification for strengthening informed consent for research using biospecimens, even when identifying data are not included. In emphasizing the importance of prohibiting unauthorized whole genome sequencing without the consent of the individual from whom the sample was derived, the NPRM cites to the ethical analysis and recommendations in Privacy and Progress. The Bioethics Commission is pleased that its work has proven useful in the proposed revisions of human subjects research regulations as they evolve to keep pace with modern advances in science and technology.

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Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/23/modernizing-human-subjects-research-protection-applying-the-principle-of-regulatory-parsimony/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/23/modernizing-human-subjects-research-protection-applying-the-principle-of-regulatory-parsimony/#comments Wed, 23 Sep 2015 15:10:12 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1719 This is the second blog post in our series Modernizing Human Subjects Research Protections, which analyzes the relationship between the recently released notice of proposed rulemaking (NPRM), proposing changes to the Common Rule governing federally supported human subjects research, and the Bioethics Commission’s work. This post reviews the relationship between the NPRM and portions of the Bioethics Commission’s response to the corresponding advance notice of proposed rulemaking (ANPRM) in 2011.

The July 2011 ANPRM sought public comment on several potential changes to research regulations. In Moral Science: Protecting Participants in Human Subjects Research, the Bioethics Commission reviewed federal and international protections for participants in human subjects research. As a part of that review, the Bioethics Commission commented on the considerations highlighted by the ANPRM.

The Bioethics Commission has long espoused the principle of regulatory parsimony—calling for only as much oversight as necessary to uphold ethical standards. Applying this principle to human subjects research, the Bioethics Commission asserted that research oversight should be restructured to appropriately calibrate the level and intensity of review with the level of risk posed to participants. Calibrating the intensity of review to the level of risk allows IRBs to give more attention to higher-risk research. The Bioethics Commission supported specific changes to the Common Rule to help foster regulatory parsimony, in particular, regularly updating the list of research categories eligible for accelerated review processes and eliminating follow-up requirements for certain lower-risk studies.

The NPRM proposes several changes that would reduce unnecessary regulation of low-risk research. Under the proposal, several low-risk activities and categories of research would no longer be deemed human subjects research under the Common Rule. Other categories of research would be assigned to accelerated review processes. Further, some studies would no longer be required to undergo annual follow-up review. Together, these changes proposed by the NPRM constitute a move towards a review system that better matches the level of research regulation to the level of risk to participants.

The Bioethics Commission supports the principle of regulatory parsimony, advocating only as much regulation as is necessary to protect participants. The NPRM proposes several changes to the Common Rule that embody the principle of regulatory parsimony. These changes are an important part of modernizing human subjects research protections.

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Modernizing Human Subjects Research Protections: A Blog Series on Recent Proposed Revisions to the Common Rule https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/10/modernizing-human-subjects-research-protections-a-blog-series-on-recent-proposed-revisions-to-the-common-rule/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/10/modernizing-human-subjects-research-protections-a-blog-series-on-recent-proposed-revisions-to-the-common-rule/#respond Thu, 10 Sep 2015 20:29:47 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1708 Last week, 16 federal departments and agencies released a notice of proposed rulemaking (NPRM) to revise the Common Rule – the regulations that govern the ethical conduct of federally supported human subjects research. This highly anticipated NPRM arrived more than four years after the July 2011 release of an advanced notice of proposed rulemaking (ANPRM) that sparked substantial commentary and debate.

In its 2011 report, Moral Science: Protecting Participants in Human Subjects Research, the Bioethics Commission analyzed current protections for research participants, concluding that the regulations generally appear to protect people from avoidable harm or unethical treatment, but also offering recommendations for improvement. Indeed, the Bioethics Commission commented directly on the ANPRM in Moral Science (Recommendation 13).

The Bioethics Commission later addressed genetic research in Privacy and Progress in Whole Genome Sequencing; pediatric research in Safeguarding Children: Pediatric Medical Countermeasure Research; incidental findings in research in Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts; and research with participants with potentially impaired consent capacity in Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society. Analysis and recommendations relevant to research ethics exist throughout the Bioethics Commission’s work.

The NPRM cites several of the Bioethics Commission’s reports, and acknowledges that “in preparing the NPRM, the deliberations of the [Bioethics Commission] were taken into account.” (NPRM, p. 397) Moreover, the NPRM’s ethical rationale in support of proposed regulatory changes often closely parallels the Bioethics Commission’s analyses of similar issues. Over the next several weeks, we will be highlighting the impact of the Bioethics Commission’s work on the NPRM, and the relationship between the Bioethics Commission’s recommendations and the proposed revisions to the Common Rule in a series on this blog called “Modernizing Human Subjects Research Protections.”

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