Tag: irbs

Bioethics Blogs

We Can and Must Rebuild the Bridges of Interdisciplinary Bioethics

by Darryl R. J. Macer

This editorial is made available on bioethics.net. The editorial along with the target article and open peer commentary is available via tandfonline.com

Although we can argue that bioethics is holistic and found in every culture, and still alive among people of many indigenous communities as well as the postmodern ones, the academic discipline of bioethics as interpreted by many scholars has attempted to burn bridges to both different views and to persons with different life trajectories and training. The bridges between different cultural and epistemological foundations of bioethics have also been strained by the dominance of Western paradigms of principlism and the emergence of an academic profession of medical bioethics.

This editorial reacts to the points made in the article by Lee, “A Bridge Back to the Future: Public Health Ethics, Bioethics, and Environmental Ethics.” This issue of the American Journal of Bioethics (AJOB) includes a number of commentaries on this theme, and challenges readers to reconsider the manner in which they conceive of bioethics, as well as the range of literature and scholars that they consider to as legitimate sources of wisdom. Such a new approach will not only breathe fresh light into the important work of all scholars, students, and teachers, but also offer some fresh references for contemporary policy changes that face us. Let us approach these issues like an ostrich who is taking her head out of the sand after some years of monodisciplinary focus. To be clear, Lee and some others writing here have apparently not had their head in the sand, as the interrelatedness of health and the environment is clear through the examples shared.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Keeping the Intersections of IBCs, IACUCs, and IRBs from Turning into Roadblocks

PRIM&R’s IBC Boot Camp, which takes place September 18-19 in Denver, CO, will provide information, tools, and guidance for IBC, IRB, and IACUC professionals to help them keep compliance intersections from turning into compliance roadblocks. Attendees will learn strategies for improving integration and communication among regulatory groups and investigators to best support research that is ethical, collaborative, and interdisciplinary. IBC personnel will have opportunities for benchmarking, sharing resources such as SOPs, and networking with colleagues in the field.

The post Keeping the Intersections of IBCs, IACUCs, and IRBs from Turning into Roadblocks appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Not Just About Consent: The Ethical Dimensions of Research Methodology Knowledge in IRBs

Guest Post: Sarah Wieten

The recent article, “Some Social Scientists Are Tired of Asking for Permission” in the New York Times inspired a great deal of debate about the role of institutional research ethics board (IRB) oversight in social science, which some argue is in most cases unlikely to involve significant harm to participants.

While the role IRBs play in sociological research is being re-examined, the importance of IRB oversight for medical research was not similarly called into question. But what exactly does IRB oversight in medical research involve? Should these groups be content with assuring that patients and participants in medical research have provided informed consent? Or do they have wider duties? What is the relationship between methodologically rigorous science and ethical science?

The approval of research projects by IRBs is an integral part of the conduct of research in universities. IRBs ensure that all research follows key ethical guidelines and is pursued for good reason, and in doing so, they aim to keep patients and participants out of harm’s way. IRBs are important gatekeepers of institutional research, and serve as a check on the work of scientists, physicians, and others who are pursuing new knowledge.

We would assume then, that people serving on IRBs have a clear understanding of relevant research design. That way, they can check the research for ethical issues stemming from the methodology. They can also make sure that methodologically poor studies do not proceed, as this would be an unethical waste of resources (and would put participants at risk without a reasonable prospect of gaining reliable knowledge in exchange).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Interview with Arthur Caplan

by Kaitlynd Hiller and Rachel F. Bloom

It is a difficult task to succinctly describe the professional accomplishments of Arthur Caplan, PhD. For the uninitiated, Dr. Caplan is perhaps the most prominent voice in the conversation between bioethicists and the general public, as well as being a prolific writer and academic. He is currently the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at NYU Langone Medical Center and NYU School of Medicine, having founded the Division of Bioethics there in 2012. Additionally, he co-founded the NYU Sports and Society Program, where he currently serves as Dean, and heads the ethics program for NYU’s Global Institute for Public Health. Prior to joining NYU, he created the Center for Bioethics and Department of Medical Ethics at the University of Pennsylvania Perelman School of Medicine, serving as the Sidney D. Caplan Professor of Bioethics. Dr. Caplan is a Hastings Center fellow, also holding fellowships at The New York Academy of Medicine, the College of Physicians of Philadelphia, the American Association for the Advancement of Science, and the American College of Legal Medicine. He received the lifetime achievement award of the American Society of Bioethics and Humanities in 2016.

Dr. Caplan’s experience is not at all limited to the academic realm: he has served on numerous advisory counsels at the national and international level, and is an ethics advisor for organizations tackling issues from synthetic biology to world health to compassionate care. Dr. Caplan has been awarded the McGovern Medal of the American Medical Writers Association, the Franklin Award from the City of Philadelphia, the Patricia Price Browne Prize in Biomedical Ethics, the Public Service Award from the National Science Foundation, and the Rare Impact Award from the National Organization for Rare Disorders; he also holds seven honorary degrees.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Getting to the CORE of MISST-Related Research

MISST is an acronym the Connected and Open Research Ethics (CORE) initiative research team uses to describe research that involves the use of mobile, imaging, pervasive-sensing, social media, and location-tracking strategies that can passively observe human behavior. The CORE is a growing community where conversations about research ethics and technology are beginning. We seek to increase awareness of this resource and we invite IRBs and research stakeholders to get involved—specifically, we want to hear from the PRIM&R community! We invite you to join the conversation by signing up for the CORE Network and sharing your questions about how to do this research and/or your expertise and lessons learned. You can also follow CORE on Twitter and LinkedIn. Together we can learn from one another and begin to have an informed discussion developing an ethical framework for MISST.

The post Getting to the CORE of MISST-Related Research appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Webinar Follow-up: Compensation or Inducement? What IRBs Need to Know about Paying Subjects for Participation

In April, PRIM&R hosted the webinar Compensation or Inducement? What IRBs Need to Know about Paying Subjects for Participation. Presented by Alex John London, PhD, and Betsy Ripley, MD, MS, RAC, this webinar provided foundational knowledge about the underlying ethical principles that govern compensating tresearch subjects. Through case studies, examples, and review of existing guidance and regulations, attendees learned strategies for evaluating payment to subjects for their participation in studies. Here, the presenters answer some of the questions time didn’t permit us to answer live.

The post Webinar Follow-up: Compensation or Inducement? What IRBs Need to Know about Paying Subjects for Participation appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Why I Marched

by Craig Klugman, Ph.D.

This past Saturday, I donned by pink knitted brain hat and joined 40,000 other scientists and allies in Chicago’s Grant Park. This unprecedented gathering was to make a statement that science is important and should be publicly supported. The march was a protest against proposed budget cuts for the EPA, NIH, CDC as well as the dismissal of scientific facts by elected officials. The March was not partisan but it was political, sending a message that federal support for science should be unwavering.

To see so many people out to support science was exciting. I saw creative costumes such as an 8-foot long, articulated dinosaur skeleton, bees, and a plush microbe. The signs were equally creative: “Spock Kitty says supporting science highly illogical,” “Science is like magic, but real,” “Silence, not silence,” “There is no Planet B,” “Science is not a liberal conspiracy,” and “Science is patriotic” among others. Perhaps most surprising to me were those present who were members of the far-right religious communities with their signs that expressed Bible verses supporting the discovery of knowledge and even a placard listing clergy who were also scientists. Science does reach across the partisan aisles.

The March was surprisingly quiet. There was little chanting of slogans as we moved slowly down the park paths. I stood by a graduate student union group that were discussing their publication plans and hopes for finding funding for their doctoral projects. I overhead others talking about how they were grateful that research led to a cure for their cancer.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Cross Post: Are Your Studies Ethically Sound?

For Sharon Shriver, it’s a simple equation. “Poorly designed research is inherently unethical,” says the director of programs for PRIM&R.

Part of the remedy, Shriver says, is to incorporate ethical considerations into study design. “It’s not a focus for institutional review boards [IRBs], but it should be,” she notes.

The post Cross Post: Are Your Studies Ethically Sound? appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Public Members Needed

The Research Involving Human Subjects Committee (RIHSC) FDA’s IRB, is looking for up to three individuals from the community to serve as public members on the committee.

 

FDA is committed to safeguarding the rights and welfare of all human beings who participate as subjects in research. The RIHSC reviews all research involving human subjects conducted, supported, or funded, in whole or in part, by FDA, to ensure that the research complies with applicable laws and ethical research standards.

 

What kind of members serve on an IRB?

 

Ideally, IRBs are made up of members from diverse backgrounds.  Diversity assures a complete and thorough review of the research activities from a variety of perspectives.

 

We are seeking community members with different kinds of backgrounds than our current members. Some examples would be educators, members of the clergy, laborers, and previous government employees who have not worked in public health agencies.

 

RIHSC membership currently has scientists, health care professionals, social scientists, and regulatory counsel.

 

What are the qualifications RIHSC is seeking in a Public Member?

 

Although not required, it may be beneficial to have experience in:

 

  • Health communication, health literacy, or plain language
  • Consumer or patient advocacy
  • Ethical analysis or

 

Community members who volunteer to be a public member for RIHSC may not be affiliated with FDA or be an immediate family member of a person affiliated with FDA. 

 

What are the responsibilities of a public member of RIHSC?

 

The public members on a rotating basis will be asked to:

 

  • Prepare for monthly committee meetings
  • Attend monthly committee meetings (typically meets for 2-3 hours on the first Wednesday of the month, during business hours)
  • Attend meetings
  • Add to the discussion and vote on the proposed study based on certain criteria, such as if the risk to subjects is reasonable, minimized, and fully disclosed to subjects.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.