Friday, January 30, 2015

Research Ethics Roundup: Priorities for Research Funding, Sharing Clinical Trial Data, and More

It has been a busy few weeks in the research oversight field with the release of a much anticipated Institute of Medicine report on data sharing and a new bill that seeks to overhaul drug and device development. Explore these and other stories below.

HHS, Research Community Debate Informed Consent Policy: This piece from Kaiser Health News explores some of the various viewpoints surrounding the changes proposed by the Office for Human Research Protections in their “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care."

How the US Underfunds Research for Migraines, Asthma and Depression: Research funding in the United States is declining, and evidence suggests that the funding that is available does not reflect the burden of disease in the United States. In this article for The Washington Post, Jason Millman explores the issue of research funding and considers the factors that influence funding determinations.

Regulatory Explainer: The 21st Century Cures Act: On Tuesday, the Energy and Commerce Committee's Subcommittee on Health released the 21st Century Cures Act, which proposes significant changes to the way drugs and devices are marketed and approved in the United States. This piece from Regulatory Focus provides an overview of the proposed changes.

Sharing Older Clinical Trial Data Should be Judicious: Earlier this month, the Institute of Medicine released a report titled Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks. In this piece for Pharmalot, Ed Silverman interviews Ida Sim, a member of the committee that developed the report, to explore the recommendations offered in the report.

Monday, January 26, 2015

New sessions at 2015 IACUC Conference incorporate attendee feedback

by Maeve Luthin, Professional Development Manager

The upcoming 2015 Institutional Animal Care and Use Committee (IACUC) Conference will feature some exciting new session topics that originated from suggestions shared in last year’s conference evaluations.

We received repeated requests to expand conference offerings for those who work with animals that are beyond the typical laboratory species. The new Not Your Average IACUC track includes sessions on working with nontraditional laboratory animals, including: A8: Managing Non-Traditional Species When They Come Into the Laboratory; A9: What IACUCs Need to Know About Laboratory Aquatics Oversight; B10: Toolbox for Protocols Using Wild Species; C8: IACUC Deliberations Using Wildlife Scenarios; and D10: IACUC Challenges When Investigators Use Large Animal Models, which will focus on the use of large farm animals in research.

Attendee evaluations also provided the genesis for Panel II: Studies of Animals When They Are the Targeted Beneficiaries. This plenary session will address the use of animals in areas other than biomedical research focused on human health, through either the spillover of diseases; unintended alteration of animal populations or communities; or changing our use of land to protect animal populations.

PRIM&R received consistent feedback about attendees’ desire to ask general questions regarding the regulations, their everyday work, and topics that arose during the conference sessions. In response to this, the final session of the conference will be a Town Hall Meeting hosted by conference co-chairs F. Claire Hankenson, DVM, MS, DACLAM, and Christian E. Newcomer, VMD, MS, DACLAM. Throughout the conference, attendees will have the opportunity to submit their questions onsite at the PRIM&R Help Desk or through email. The co-chairs will review the submissions, choose those that will be of interest to the larger group, and invite experienced veterans in the field to provide their answers and insight.

We can’t wait to see these sessions in action while onsite in Boston at the 2015 IACUC Conference. Thank you to those who took the time to complete their evaluations in 2014—we hope that everyone will continue to share their great ideas with us!

Friday, January 23, 2015

The Shift Toward Training and Documentation of Proficiency

by Anne Meade, MS, PMP, senior manager for website and social media

The most recent revisions to the Guide for the Care and Use of Laboratory Animals highlighted the importance of training for individuals involved with the care and use of animals. As Chris Newcomer explains in this excerpt on People & Perspectives, this was a welcome addition.
“I’ve seen indiscretions done in animal research…they almost always result not from somebody’s maliciousness; they result from their arrogance of thinking that they know enough to do a procedure the right way.”
Dr. Newcomer goes on to state that while the Guide has always indicated that training should be provided, “the more recent Guide sends a much stronger proposition about the importance of training.” But it’s more than just training—more principles and regulations are including proficiency in their revisions. Training needs to happen through a process of documentation that illustrates proficiency. “It’s a paradigm shift that is decades overdue.”

Watch the full excerpt below:


Have you seen a shift at your institution toward documenting proficiency? Have the attitudes about training shifted at all? Share your thoughts in the comments below!

Interested in learning more about training members of your IACUC? Join us at the 2015 IACUC Conference for sessions discussing this topic, such as “Training and Assessment for IACUC Members and Staff ,” or “Training and Information for Students Working with Animals in Coursework Activities.”

Thursday, January 22, 2015

PRIM&R’s Response to OHRP’s Draft Guidance on Research Evaluating Standards of Care

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

Research on the comparative effectiveness of commonly used interventions is becoming increasingly common as clinicians, researchers, and healthcare funders seek to improve the efficiency and effectiveness of health care by developing a strong evidence base about medical interventions. With the growth of such efforts, questions have emerged about how oversight rules and mechanisms for the protection of human subjects should apply to such endeavors.

In October, following more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the federal regulations for the protection of human subjects apply to research evaluating alternative interventions that all meet the standard of care for preventing, diagnosing, or treating a particular condition.

In an earlier post, we provided an overview of the draft guidance, titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care,” and today, we are pleased to make available PRIM&R’s response to the draft. PRIM&R appreciates the OHRP’s efforts to foster public discussion and provide the research community with guidance on how to ensure adequate protections for human subjects in research evaluating one or more interventions that are within the standard of care. PRIM&R believes, however, that the current document does not provide the comprehensive assistance needed by investigators and IRBs, and, in our comments, urges the OHRP to rewrite the document to provide clearer guidance.

Concerns Regarding the Current Draft Guidance

In our response, PRIM&R expresses concern that the draft guidance appears to be limited to research whose purpose is to evaluate the risks of two or more “standard of care” interventions. PRIM&R does not believe such an approach provides the comprehensive guidance on comparative effectiveness research (CER) that is needed, given, for instance, the fact that studies of marketed drugs are typically designed to compare efficacy/effectiveness or benefits, as opposed to differences in risks.

While PRIM&R agrees with the draft guidance that any significant differences in the “foreseeable risks” of research must be disclosed, we also suggest that a shift in emphasis would better achieve the OHRP’s main goal, namely, “that the distinction between receiving clinical care and participating in research must be made clear to subjects.” Thus PRIM&R encourages the OHRP to place less emphasis on risks and focus instead on the need for investigators to make clear to potential subjects that they have a choice of whether to receive one of the interventions in a clinical context, or to assist investigators in learning more about comparative benefits, risks, costs, and so forth by receiving one or another of the interventions on a randomized basis in a trial.

Furthermore, we suggest that, when there are significant differences in the potential harms of the interventions being compared, those differences likely affect potential subjects’ decisions of whether or not to participate in the trial. But that there should be no implication that when differences in potential harms are much smaller, or even nonexistent, there is thus nothing left for subjects to decide.

Indeed, it is PRIM&R’s view that the central concern in research evaluating one or more accepted interventions should be ensuring that potential subjects understand (a) that they are being asked to participate in research, (b) the nature of the research question being investigated, and (c) how their care as research subjects may differ from care they would receive in the clinical context. Given the importance of providing guidance in this area, we strongly urge the OHRP to use this opportunity to reformulate the draft guidance to better address that concern.

Recommendations for Future Guidance

To assist the OHRP with the process of rethinking and reformulating its guidance in this area, PRIM&R puts forward three recommendations:

  1. Investigators, sponsors, and IRBs should ensure that protocols involving the comparison of two or more interventions that meet the relevant standard of care make clear what question(s) are being studied and the importance of the question(s) under study. IRBs should also ensure that the study, as designed, can provide answers to those questions.

  2. IRBs, investigators, and sponsors should make certain that the information provided to potential subjects during recruitment or consent for research evaluating one or more standard-of-care interventions adequately conveys, in an understandable fashion, what is being studied, the importance of the question under study, and how a potential subject’s care may differ in the clinical research context, as opposed to the clinical context alone. Potential subjects should also be made aware how interventions will be assigned (e.g., randomly) and that, when so specified by the protocol, neither they nor their health care practitioner will select the intervention they receive.

  3. Explanations provided to potential subjects should reflect the magnitude of the potential risks and benefits associated with the interventions under study, while ensuring that potential subjects are provided with all of the information necessary to make an informed decision.

We encourage you to read PRIM&R’s complete response to OHRP, and to share your thoughts about PRIM&R’s comments or the OHRP’s draft guidance below.

Tuesday, January 20, 2015

It is a Small World: Networking at PRIM&R’s IACUC Conference

by Derek Fong, VMD, DACLAM, Clinical Veterinarian at the University of Colorado Denver

As we gear up for the 2015 IACUC Conference, which will be held in Boston, MA, from March 17-20, we are pleased to have an opportunity to share a post from Derek Fong, who served as a member of the PRIM&R Blog Squad at the 2014 IACUC Conference

It has been nearly a year since I participated as a member of the PRIM&R Blog Squad at the 2014 IACUC Conference, and yet, I still find myself thinking about the powerful connections—old and new—that I made at the conference. Reflecting back, one story, in particular, comes to mind.

With so many concurrent breakout sessions to choose from, selecting what I wanted to attend at the 2014 IACUC Conference was challenging. As I reviewed my options, I skipped over a special lunch session titled, “Research Ethics Book Group Lunch and Book Signing with Author Emily Anthes,” figuring I would be busy eating, conversing, catching up via my ever-present Blackberry, or taking a needed mental break during that time. However, on the day of the session, I ran into a colleague, who asked if I was planning on attending. She couldn’t make it, but had purchased Anthe’s book, Frankenstein’s Cat: Cuddling Up to Biotech’s Brave New Beasts, and was hoping that I might be able to help get her book signed.

Happy to lend a hand, I quickly ate my lunch and went to the lobby to find the book signing. As I waited in line, I saw Emily from a distance, and immediately realized that she looked just like a former classmate, who I had not seen in a number of years. I flipped to the back of the book to find her biographical information and quickly deduced that she was indeed my former classmate.

As I approached the table, she probably thought I was crazy because of the giant smirk on my face. However, after confirming with her the year she graduated, I reminded her that we were in the same organic chemistry laboratory group at Yale many years ago. She commented that I looked familiar, and we chatted briefly.

It struck me as we were talking that I likely would not have run into Emily again had it not been for our mutual attendance at the conference. One of the things I love about this field is that it is a small, tight community. I’m still a relatively new member, but I hope to get to know many more people in time. This highly unlikely encounter was just another reminder that it’s a small world and that you never know whose path you will cross again.

After the conference was over, I went home and immediately purchased and read Emily’s book, which examines “how biotechnology provides us new tools to reshape animal bodies and brains.” It was entertaining, informative, and witty, which is not an easy task, especially for a science writer. The praiseworthy reviews from noted sources such as Publisher’s Weekly and The New York Times were well-deserved. It was accessible to a lay reader, and, as a member of the field, I still learned many interesting and amusing anecdotes, and all because of a chance encounter at the 2014 IACUC Conference.

Interested in giving Ampersand readers an inside peek of what goes on at the 2015 IACUC Conference? Apply to join the PRIM&R Blog Squad at the 2015 IACUC Conference by January 30