Friday, February 27, 2015

Research Ethics Roundup: The Return of Psychedelic Research, Organs on a Chip, and More

This week’s Research Ethics Roundup highlights ethical issues related to clinical trials studying the psychedelics, as well as moves toward making research more efficient, innovative, and transparent.

The Trip Treatment: Author and journalist Michael Pollan reports on the reemergence of research on psychedelics. In this article from The New Yorker, Pollan shares stories of participants and their experiences in clinical trials studying the psychedelic psilocybin.

Clinical-Trial Specialist Could Be Next FDA Chief: In this article from Nature, journalist Heidi Ledford provides background on Robert Califf, who was recently appointed a deputy commissioner at the Food and Drug Administration (FDA). There is speculation that Califf will be named as the next commissioner for the FDA, following the departure of Margaret Hamburg.

Research Misconduct Often Goes Unreported In Published Studies: Ed Silverman of The Wall Street Journal discusses issues with transparency and underreported cases of research misconduct in published studies. Silverman also explores the role of the FDA in disclosing allegations of misconduct.

Young Scientists Lead the Way on Fresh Ideas: In this article from Nature, journalist Ewen Calloway discusses new research by economists Mikko Packalen and Jay Bhattacharya of the University of Waterloo in Canada that suggests that younger scientists are more innovative than older scientists.

Reducing Animals in the Lab One Chip at a Time: Editor-in-chief of Laboratory Equipment Magazine Michelle Taylor reports on efforts to reduce the need for traditional animal studies by implementing new methods for evaluating drug safety. Highlighted in the article is Donald Ingber’s work on the development of organs-on-chip, "which allows researchers to recreate the physiological and mechanical functions of the organ, and to observe what happens in real-time."

Thursday, February 26, 2015

When is it Unethical Not to Engage in Research?

by Anne Meade, MS, PMP, Senior Manager for Website and Social Media  

For its February Question of the Month, PRIM&R’s People & Perspectives  program wants to know why you think collaboration is important.

Need inspiration? One thing to consider is how you approach conflicts of interest at your organization. Can you consider these as opportunities for convergence, as opposed to simply conflicts of interest? Instead of seeing a conflict of interest as a means of discontinuing research, take it as an opportunity to collaborate to execute the research.

For more on this topic, watch the following People & Perspectives interview, in which Ann Bonham, PhD, chief scientific officer at the Association of American Medical Colleges (AAMC), discusses the value of true partnership between the major stakeholders in research.

Dr. Bonham emphasizes that acknowledging conflicts of interest is not merely "checking the box"—one also has to think about ways to move research forward if there is significant financial conflict of interest. It may not be ethical to form a partnership because of a conflict, but when is it unethical not to partner and move the research forward?
“Let’s elevate the discussion that finances [are] one part of it, but there are lots of other parts of it. It’s not asking, ‘This is not ethical so let’s not engage in research.’ Let’s ask ourselves how to put that into context, and also ask ourselves when would it be unethical for us not to engage in partnerships to do the research. And to me that’s the crux of the principled partnerships: thinking about the ethics of not doing it and the ethics of doing it.”

Watch the full video.

How do you handle opportunities for convergence of interests, and how are those opportunities important for collaboration? Respond to the Question of the Month on the People & Perspectives website, or share a comment below.

Wednesday, February 25, 2015

Opting Out: Who’s Protecting Human Research Subjects Online?

by Anita Pascoe, MS, CIP, project coordinator at Intermountain Healthcare

Time has flown by since December’s 2014 AER Conference. The holidays came and went, and, believe it or not, spring has announced its extremely premature arrival here in Salt Lake City. Two months post-conference, I am, however, still contemplating several of the key themes discussed during the four days in Baltimore. Topping my list of memorable conference moments is John Wilbanks’ keynote address, which hit home for me on a personal as well as a professional level.

Wilbanks noted that the nature of our global research enterprise has forever been altered because of the widespread use of mobile technologies, which enable easy and inexpensive access to myriad amounts of data. PRIM&R as a whole clearly agreed, as several other conference sessions were dedicated specifically to addressing issues related to the exponential growth of real-life, real-time data collection enabled by mobile technologies.

One of Wilbanks' most poignant points, however, was his description of how our contemporary culture endorses the practice of blindly clicking "I agree" or "OK" to online user agreements or disclosure documents without reading so much as a single word. Hence, Wilbanks concluded, cheap data amassed daily by modern technologies intersects with efforts to protect consumers from potential risks and harms, which in turn also ends up being a concern for researchers.

As I mentioned in one of my posts during the conference, I recently acquired my first smartphone. Wilbanks' remarks therefore had particular impact on me. I had never focused any personal attention on the phenomenon of "blindly agreeing" online. Now, smartphone in hand and fresh from the 2014 AER Conference, I decided I would pay attention to offers and requests I received to see if the problem really is as widespread as Wilbanks claimed. Since then (early December), I have received and accounted for 198 invitations to download free apps, 102 games, and hundreds of commercial solicitations, coupon offers and "specials." I am simply stunned by the sheer volume of unsolicited "stuff" that comes my way every day. When did I consent to receiving any of it? I haven’t a clue.

From an institutional review board perspective, informed consent is a pillar of a human research protections framework. If, as Wilbanks suggested, our current data protection infrastructure is indeed no longer efficient or adequate in this era of online apps and big-data, how can we retool, restructure, and revamp our current practices to better fit our current situation?

I am personally favoring the notion of going back to using a "dumb phone" to stop the incessant bombardment of data. But I know the suggestion of rolling back technological advances like some anti-Internet Luddite is not the answer. My tech savvy son says I just need to "delete some junk, change my preferences, and set my filters." That might be the answer for my phone, but who and what is out there to protect potential human research subjects in a world where the default is now "opt in” not "opt out?"

Wednesday, February 18, 2015

The Persistence Of Community

by Michael (Mike) Kraten, PhD, CPA, IRB chair at Providence College

As the chair of our college's institutional review board (IRB), you can only imagine how frequently I am asked questions about the 45 CFR Part 46 federal regulations regarding the requirements of human subjects research.

What types of questions? For instance:

  • I'm not sure whether my study is contributing to "generalizable knowledge." How can I tell whether it's doing so?
  • How can I possibly know whether I'm potentially damaging someone's "financial standing, employability, or reputation" with my work?
  • When does a "practicable" study become impracticable?

These questions, though tricky, are certainly not impossible to answer. Occasionally, though, a quirky query leaves me searching for an appropriate response. For instance, a colleague recently asked me:

  • How can I learn about the OHRP regulations without reading them?

Huh? How can any one possibly expect to learn about information without reading it? It would have been easy to dismiss his query as a facetious one, but I understood my colleague's dilemma.

You see, if English is not a researcher's native language, the OHRP regulations can represent a daunting "wall of text" that is extremely difficult to decipher. Heck, even monolingual English speakers (like me) can struggle to understand the dense verbiage.

Indeed, even our IRB's explanatory guidance relies on long English sentences and paragraphs to communicate our policies. Any native speaker of an Arabic, Cyrillic, or Hebrew language would naturally prefer some other means to master the information.

At first, though, I couldn't think of a more accessible resource for my colleague. And then...aha! I remembered a passing anecdote by a 2014 Advancing Ethical Research (AER) Conference presenter that later generated some animated discussion at a networking event.

The anecdote involved the communication of informed consent terms to illiterate human subjects in an emerging nation. The researchers chose to explain the relevant principles by role-playing through a theatrical skit. (Could I find an online video that captured their guidance? Alas, despite my web searches, I could not do so.)

But while searching for this video, I discovered a set of OHRP Decision Charts that explains the regulations in a visual context. I forwarded the set to my colleague, who found them far more comprehensible than the traditionally presented "wall of text."

Thus, my most recent "useful AER Conference recollection" wasn't gleaned from a handout or a PowerPoint slide. It was, instead, an anecdote that I heard from a session presenter and then discussed with colleagues.

In other words, it was knowledge that only persisted in my memory because I first absorbed the information while meeting within a community of researchers. Indeed, it is the very persistence of that community that helps to generate such immense value at the AER Conference.

Have a helpful resource to share? Share a link in the comments or submit the material to PRIM&R for inclusion in the Workplace tools section of our Knowledge Center. Need a specific tool to facilitate IRB or IACUC education, protocol review, or another work-related challenge? PRIM&R members have access to hundreds of items in the PRIM&R Knowledge Center to make their jobs that much easier.

Friday, February 13, 2015

Research Ethics Roundup: Conducting Research in Resource-Limited Settings, Animal Models for Ebola Research, and More

This week’s Research Ethics Roundup explores ethical issues related to the conduct of research in resource-limited settings and reproducibility, as well as issues related to the development of Ebola treatments. Read on to find out more and discover what’s happening in the world of research ethics and oversight.

A Failed Trial in Africa Raises Questions About How to Test HIV Drugs: Donald J. McNeil Jr. reports on a clinical trial that was recently halted in South Africa, Zimbabwe, and Uganda in this article for The New York Times. The failed trial, which sought to evaluate the efficacy of HIV pre-exposure prophylaxis, has brought to the forefront questions about the ethical conduct of research in resource-limited settings.

In Rush to Develop Ebola Therapies, a Debate Over Placebo Control: The  Presidential Commission for the Study of Bioethical Issues met last week to discuss ethical considerations of neuroscience research, as well as the public health to Ebola. In this blog post, Matthew Davis summarizes the Commission’s discussion regarding the use of placebos in the development of new Ebola therapeutics.

Look to Animals to Cure Ebola
: In this op-ed from The Baltimore Sun, Frankie L. Trull, president of the Foundation for Biomedical Research, reflects on the use of animal research in the development of vaccines and therapeutics for infectious diseases, including Ebola. Trull provides specific examples of Ebola therapeutics that have benefited from the use of animal models.

Sweeping Plan to Revamp Biomedical Innovation Includes Controversial Ideas for NIH: In January, the US House of Representatives, led by Fred Upton (R-MI) and Diana DeGette (D–CO) of the House Energy and Commerce Committee, issued a discussion draft of the 21st Century Cures Act. In this article from Science Insider, Kelly Servick and Jocelyn Kaiser explore the lengthy proposal, which is aimed at speeding the “discovery, development, and delivery of promising new cures and treatments.”

The New Scientific Revolution: Reproducibility at Last:  In this article from The Washington Post, Joel Achenbach explores how concerns about reproducibility of results are driving researchers, publishers, regulators, and pharmaceutical companies to rethink how they approach data sharing and transparency in research.