Human Subjects Research Rule Revisions Finally Proposed

More than four years after the federal government introduced an advanced notice of proposed rulemaking on federal regulations on human subjects research (called the Common Rule), there has been another regulatory step (H/T ScienceInsider).

The Federal Register has a draft edition of the notice of proposed rulemaking it will publish on September 8.  Comments will be due in 90 days from the date of publication, which would be around December 6.  The draft notice is over 500 pages, so I will have additional posts on the subject once I have the chance to review this in more detail.

Quick thoughts on a first glance.

If this is implemented as written, it will affect researchers in a number of different fields (16 federal agencies are listed in the proposed rules, but not the Office of Science and Technology Policy), and it seeks to define areas of activity that would or would not be covered under the proposed rules.

(Two agencies – the Department of Housing and Urban Development and the Consumer Product Safety Commission – will update their Common Rule regulations through separate proceedings.  The Department of Labor is not currently covered by the Common Rule, but has joined this rulemaking in order to adopt those regulations.)

The proposed changes are necessary to do the heavy lifting required to update a 24 year-old rule.  With the continued changes in technology, whatever final rule that emerges will become dated quickly.  Having a means of effectively assessing and adapting to future changes in technology and research capabilities would be nice to have.

Even if you don’t think work you’re engaged with isn’t covered by federal human subjects research regulations, read the notice.  You might be surprised.

Informed Consent Teases Out Research Ethics On The Stage

Informed Consent is currently in its New York premiere run at the Duke at 42nd Street through September 13.  The play was written by Deborah Zoe Laufer and is a fictionalized drama about the case of the Havasupai Tribe in Arizona and its lawsuit against researchers at Arizona State University.  The case concerns the use of blood samples taken from tribe members by the researchers.  While the samples were taken voluntarily for the purposes of a diabetes study, the use of these samples in subsequent research prompted the lawsuit.  (The lawsuit eventually ended in an out-of-court settlement, not the most dramatically satisfying of conclusions.)

Laufner was featured on a recent segment of Science Friday, where she talked with Ira Flatow about the play, the case, and the ethics involved in genetic research, informed consent, properly managing genetic data, and issues of identity.  While the court case started over 25 years ago, the challenges of determining how to practically ensure ethically-informed consent for the drawing of samples and use of genetic information.  The ultimate resolution of the case prevented the establishment of relevant case law to inform subsequent court cases.

The court case also raised an issue about genetic migration studies.  Determining the genetic ancestry of individuals can conflict with family and/or cultural understanding of where people came from.  And while individuals being tested might accept such a conflict, there are others who would be exposed to the conflict that were not consulted about the testing.  Figuring out how to set boundaries in such matters is something worthy of consideration by the Presidential Commission for the Study of Biomedical Issues.

But none of that necessarily makes for a good play.  Readers in the New York area (or visiting) still have a few days to check out Informed Consent.

Precision Medicine Initiative Seeks Input On Privacy and Trust Principles

I completely missed this one when it was announced in early July, but the interagency working group on the Precision Medicine Initiative (PMI) is working on privacy and trust principles to guide the project.  It is seeking public comment on a proposed set of principles, but the deadline is Friday, August 7.

The principles are intended to guide the PMI in the large-scale data collection and analysis that is critical to the project.  The PMI is trying to gather data voluntarily from a large cohort (at least one million individuals) and allow responsible access to that information by a large number of researchers and institutions (and the members of the cohort itself).  Solid privacy and trust principles, with an implementation and enforcement regime behind it, can engender sufficient confidence in the public for the project to reach its million-member cohort.

In parallel with this process, the principles indicate there will be work on a data security program for the PMI.  I have not yet found any working documents on that program, but I will link to them from this blog once I do.

Next Bioethics Commission Meeting Will Continue Deliberations On Deliberation

The Presidential Commission for the Study of Bioethical Issues will next meet September 2 in Washington, D.C.  As is the current practice, there will be a live webcast and the Commission staff will liveblog the meeting.

Per the Federal Register notice (a formal agenda is not yet available), the meeting will continue the work it started at its May meeting in Philadelphia.  Topics will include:

  • The role of deliberation and deliberative methods to engage the public in bioethics, and how to integrate pubic dialogue into the bioethics conversation;
  • Bioethics education as a forum for fostering deliberative skills, and preparing students to participate in public dialogue in bioethics;
  • Goals and methods of bioethics education; and
  • Integrating bioethics education across a range of professional disciplines and educational levels.

There may or may not be a formal report coming from these discussions.  Given the nature of these topics, I think the Commission could simply augment its ongoing efforts in bioethics education with some public experiments in new techniques involving deliberation and deliberative methods.  This is a particular theme in Chair Amy Gutmann’s research, so I am not surprised to see the level of commitment to this effort.

(While a very politically charged matter due to recent events, it is possible that the Commission could be tasked with, or asked by the public about, current practices in fetal tissue collection and use.)

Fish And Wildlife Service Providing Additional Details For New Chimp Research Requirements

Earlier this summer the Fish and Wildlife Service (FWS) classified captive chimpanzees as endangered – the same as chimpanzees found in the wild.  Starting September 14, most biomedical research involving captive chimpanzees will require a permit.

In a meeting with staff of the Federation of American Societies for Experimental Biology and the American Physiological Society, the FWS provided additional information about the process.  The permits would be required for most instances where the research would harm, harass, kill or injure a chimpanzee, as this is otherwise a violation of the Endangered Species Act.  There will be two types of research eligible for a permit: research that directly benefits conservation efforts for wild chimpanzee populations and research that doesn’t directly benefit such conservation efforts but includes support for in situ conservation efforts (though federal grant money cannot be used to pay for such efforts).  In other words, if there’s no direct benefits to conservation efforts in the research, a successful permit will involve a little extra support (not from the government) to support conservation efforts.

Permits should take about 3 months to complete, which includes a 30 day public comment period.  Once approved, such permits will be valid for five years, with annual reports required.  Entities interested in the permitting process should reach out to the FWS for a conversation.

APA Not Waiting For Council Meeting To Act On Collusion Report

Yesterday the American Psychological Association (APA) announced the retirements and resignations of several high-ranking officials.  Even the press release acknowledges that the recent release of the report on APA collusion with the government affected these departures.  While the APA has made recommendations to its Council of Representatives meeting next month, ongoing criticism of the association made more immediate

Leaving are the Chief Executive Officer, the Deputy Chief Executive Officer and the executive director for public and member communications.  While not mentioned in the press release, ScienceInsider is reporting that the APA ethics director is also leaving.  They will depart between the end of this month and the end of the year.  Other departures may be forthcoming, based on the recommendations of APA critics that reviewed the report prior to its release.

Additionally, two former APA Presidents have released a response to the report, which includes discussion of some of the collusion claims.  The former presidents acknowledge that the APA response was poorly executed, but they assert that the association did what it could with the information that it had.  That Hoffman and his staff have said something similar about their report suggests that definitive answers will be hard to find agreement.

The former presidents do raise two point worth considering for any scientific society.  First, the APA lacked the resources and the mechanisms to conduct the kind of investigation into abuses involving psychologists and physicians that critics have called for.  I suspect that is true of other scientific societies.  The former presidents also ask why other societies have not been subjected the kind of scrutiny that the APA has.  For me, that speaks to a larger issue of scientific conduct, and to what extent scientific societies are (or are not) dealing with the misconduct of their membership.

While these points might be made from a defensive crouch by these former association presidents, it’s worth noting how difficult it could be for scientific societies to actively police misconduct, and how ill-prepared they might be to do so.

APA Report Indicates Evidence Of Collusion On Interrogation Policy

Last November the American Psychological Association (APA) launched an investigation in response to allegations by author James Rosen.  Rosen alleged in his book Pay Any Price: Greed, Power, and Endless War that the association colluded with George W. Bush Administration officials in the development of so-called ‘enhanced interrogation’ techniques.  In response, the APA engaged attorney David Hoffman (a former assistant U.S. Attorney) to conduct the investigation, and the report was released on Thursday (H/T The Washington Post).  The report release is in advance of the APA Council of Representatives meeting in August.

The report is extensive, over 560 pages plus appendices.  Hoffman and his staff have detailed the challenges they have had in meeting with witnesses, many of whom have either declined to do so or delayed meeting for months.  The report takes pains to state it does not provide a definitive answer to the matter, but provides as many answers as it could, while organizing and presenting the evidence they have as best they believe they could.

Bottom line, the report indicates there was collusion between elements of the APA and various government agencies over the use of psychologists in connection with ‘enhanced interrogation’ techniques.  While the report did not find evidence that APA officials knew of a program using such techniques, it did find that officials had reason to suspect that abusive interrogations had occurred.  Those officials also took steps to avoid confirming such suspicions.  The collusion extended to developing APA policies that would not place additional constraints on Department of Defense interrogation practices.

The APA Board of Directors regrets these activities and apologized for them in a press release associated with the report.  The Board has also recommended the following policy actions to the APA Council, which meets in August.

  • Adopt a policy prohibiting psychologists from participating in interrogation of persons held in custody by military and intelligence authorities, whether in the U.S. or elsewhere, but allowing training of military personnel on recognizing and responding to persons with mental illnesses, on the possible effects of particular techniques and conditions of interrogation and other areas within their expertise;
  • Create a Commission to evaluate and recommend changes to APA ethics processes;
  • Adopt formal guidelines to ensure that all relevant policies are anchored in APA core values, including promoting human rights, human welfare and ethics;
  • Approve the substitute motion of Council New Business Item #23B, which clarifies the role of psychologists related to interrogation and detainee welfare in national security settings and safeguards against acts of torture and cruel, inhuman or degrading treatment or punishment in all settings.

The Board also approved the following actions:

  • Increase the organization’s engagement around human rights activities in collaboration with other organizations;
  • Collaborate with the Council to create governance constraints on elected and appointed APA officials;
  • Evaluate existing conflict-of-interest policies regarding financial, policy or relationship-based conflicts to ensure the policies are understood and followed;
  • Adopt clear procedures for appointing members to APA Task Forces and Commissions;
  • Create specific criteria for emergency action by the Board.