Tag: institutional review boards

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 News

American CRISPR Experiments and the Future of Regulation

By Michael S. Dauber, MA, GBI Visiting Scholar

According to a report in The MIT Technology Review, researchers in a lab based in Portland, Oregon have successfully created genetically modified human embryos for the first time in U.S. history, using a technique called CRISPR. The project, directed by Shoukhrat Mitalipov, a researcher at Oregon Health and Science University, was published in Nature, and consisted of modifying the genes of human embryos to prevent a severe, genetically inherited heart condition. The embryos were destroyed several days after the experiments.

CRISPR stands for “clustered, regularly interspaced, short palindromic repeats.” It is a genetic editing technique that allows scientists to cut out pieces of DNA and replace them with other pieces. CRISPR originated as a naturally occurring cellular defense system in certain bacterial that allows a cell to defend itself from foreign genetic material injected into cells by viruses. RNA strands that match the problematic genes bind with the piece of DNA to be removed, and enzymes work to remove the defective material. When CRISPR is used to edit the human genome, scientists apply CRISPR RNA strands and the corresponding enzymes that match the genes they wish to edit in order to extract the problematic genes.

Mitalipov is not the first scientist to use CRISPR to edit the human genome. Scientists in China have been using the technique in research using human embryos dating back to 2015. One notable study consisted of attempts to make cells resistant to HIV. Another controversial study involved the injection of CRISPR-modified cells into a patient with advanced lung 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 Blogs

A New Common Rule for Human Subject Research

On January 19, 2017 – one day
before the expiration of President Obama’s second term – the Office of Human
Research Protection (OHRP) in the Department for Health and Human Services issued
a revised regulation dealing with the “Common Rule.” The final regulation is officially
titled “Federal Policy for the Protection of Human Subjects (known as the
“Common Rule”). 

The
new regulation is the product of years of study and deliberation offered as an
update of the Common Rule introduced more than 25 years ago. It’s considered a
“common rule” because it applies to the clear majority of all federal agencies
which fund human subjects research grants and contracts. Of course, the principal
objective of the Common Rule is to have a uniform inter-agency approach to
human subject protections through local institutional review boards (IRBs).

As
one might expect with many federal regulations, rules quickly become outdated
because they simply cannot keep up with technological advances. With the last
issuance of the Common Rule in 2005, regulators probably gave little thought to
the future problems that might occur with universal computerization of research
data and health records, tissue banking, genomic medicine initiatives,
personalization of therapies, and global privacy concerns.

The
new Common Rule helps a great deal in that it: (1) clarifies the categorization
of “exempted” or “excluded” research projects using risks to patients as
measures; (2) improves the elements of informed consent required and mandates
posting of the forms online in certain cases; (3) gives researchers broader
authority in using identifiable and future deidentified biologic specimens with
and without specific consent; (4) allows the use of a single IRB to oversee
multi-institutional projects within the United States; and (5) specifically
excludes routine and emergency public health surveillance work from human
subjects research.

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 is Felice Levine satisfied?

Inside Higher Ed reports that Felice J. Levine, executive director of the American Educational Research Association, is happy with the final rule. I’m curious about why; it doesn’t seem to give her anything she asked for in 2011.

[Scott Jaschik, “U.S. Issues Final Version of ‘Common Rule’ on Research Involving Humans,” Inside Higher Ed, January 19, 2017.]

[Edited at 11:12AM to mention the normal educational practices in penultimate paragraph.]

Here’s Scott Jaschik’s reporting on social science reactions to the final rule:

Early reactions from social science groups to the changes in the common rule were positive. Various provisions suggest that institutional review boards, which must review proposals to study humans, work to understand the needs of different kinds of researchers, and that there are different levels of risk associated with taking an experimental drug and answering confidential survey questions.

A statement from Felice J. Levine, executive director of the American Educational Research Association, said, “The revised regulations definitely show the care and hard work that went into this extensive effort to modernize the common rule. An open process that began in July 2011 has led in January 2017 to regulations that are more nuanced and that far better align human research protection and social and behavioral science research, taking into consideration level of risk and benefits. It is a fine outcome for research participants and for human science.”

For anthropology, the reaction was more mixed. Anthropologists pushed hard for specific mention of “participant observation” (a key tool of their discipline). The hope is that mention of this methodology will make it easier for institutional review boards to approve projects involving this approach.

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

The ‘P’ Word: Hospital Ethics Committees and Palestinian National Identity by Guy Shalev

Anthropologists like to tell their stories of ‘entering the field,’ whether they are left alone on a tropical beach as their dinghy sails away (Malinowski 1922) or run away from the police into a local’s courtyard (Geertz 1973). These stories are often told to show us, their readers, the distance anthropologists must travel from their own worlds into those of their research subjects. If stories traditionally fall within the thriller or adventure genres, my own is rather more Kafkaesque. And much like the stories from The Trial and The Castle, it is more about the system in which my interlocutors and I live than our own personal stories.

It took me more than six months to get my research with Palestinian physicians approved in two large Israeli hospitals. In a third hospital my access was denied. My ‘entry story’ is thus about my repeated attempts to obtain the approval of three Helsinki Committees (HCs, Israeli hospitals’ research ethics committees) to conduct ethnographic research with Palestinian physicians in Israeli public hospitals. While my research was eventually approved in two of these institutions, correspondence with HC representatives, as well as evidence of their informal moves with institutions’ management, reflect their perceptions of the risk my study posed.

I had already passed the University of North Carolina’s meticulous ethical approval process, and so the very different response of Israeli committees left me bewildered. Had the UNC’s committee overlooked important risks? In fact, the discrepancies between these committees calls into question the very idea of a universal ethical code of research conduct, as the 1964 Declaration of Helsinki aimed to establish.

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

The Predictive Power of Neuroimaging

By Ethan Morris
This post was written as part of a class assignment from students who took a neuroethics course with Dr. Rommelfanger in Paris of Summer 2016. 

Ethan Morris is an undergraduate senior at Emory University, majoring in Neuroscience and Behavioral Biology with a minor in History. Ethan is a member of the Dilks Lab at Emory and is a legislator on the Emory University Student Government Association. Ethan is from Denver, Colorado and loves to ski.   

Background and Current Research
Neuroscience is a rapidly burgeoning field that is increasingly facing complex issues as scientists learn more about the human brain and by extension, about personal identity. One technology that has gained attention in the last two decades is brain imaging, a technique that uses various tools to evaluate the brain’s functional response to the world. Some of the more commonly used brain imaging devices are functional magnetic resonance imaging (fMRI) and positron emission tomography (PET), both of which measure blood flow (albeit by different mechanisms) through the brain. These blood flow results show which areas of the brain are metabolically active, and are thus activated by the task at hand. Using these devices, researchers can determine the activity of certain brain regions associated with certain types of sensory and perceptual processing, as well as cognitive function.

While used in clinical settings for neurological and psychiatric diagnoses, neuroimaging is also applied in a variety of research contexts to learn about the neural correlates of human behavior. One study examined fMRI activation levels in the amygdala, one of the brain’s centers for processing salient stimuli and emotion.

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: Navigating the New Reliance Agreement Landscape

On July 12, 2016, PRIM&R hosted a webinar titled Navigating the New Reliance Agreement Landscape, presented by Tracy Ziolek, MS, CIP, and Emily Chi Fogler, Esq. This webinar highlighted the necessity for institutional review boards (IRBs) to adapt to new requirements related to multi-site research.

The post Webinar Follow-Up: Navigating the New Reliance Agreement Landscape 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

Single IRB Policy to Streamline Reviews of Multi-Site Research

July 29, 2016

(NIH) – Accelerating clinical research studies benefits researchers, research participants, and all who stand to gain from research results. Today, the time it takes to go from a sound research idea to the launch of a new, multi-site clinical research study is too long. A major contributor to the delay is that too many institutional review boards (IRBs) are reviewing the protocol and consent documents for the same study, often with no added benefit in terms of the protections for research participants. To address this bottleneck, NIH has issued a new policy to streamline the review process for NIH-funded, multi-site clinical research studies in the United States.

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

Medical Education Research and IRB Review

By Emily Anderson

Medical school curricula now emphasize evidence-based medicine.  We also need to prioritize evidence-based educational strategies.  There are some great educational innovations happening at our medical school, but too few publications highlighting these.  Conducting research on medical education faces many barriers, not least of all, lack of funding.  Publication in any peer-reviewed academic journal usually requires some evaluation data; to get in a top-tier journal, you need solid research methodology, clearly defined outcome measures, and sufficient sample sizes.  Medical education journals are notorious for rejecting small pilot studies, which is discouraging.  Perhaps even more daunting are the Institutional Review Boards (IRBs).  Studies indicate that medical education researchers face challenges in IRB submission and review (1,2).  Unfortunately, we often end up implementing new programs – and maybe even doing a solid program evaluation – but never sharing what we’ve learned with colleagues outside our own institution…

My own scholarship focuses primarily on research ethics, and I am in a Department of Medical Education.  Thus, I can’t help but think about the ethics of medical research.  First and foremost, I believe that generating and disseminating knowledge is a professional obligation of all medical educators.  But I must admit, even I am intimidated when preparing an IRB application.  The federal research regulations were designed primarily with biomedical research in mind, not medical education research.  Typically, an academic medical center’s IRB is set up to review complex drug study protocols that pose significant risk to patient-participants. The methods of medical education research are unfamiliar.  Those responsible for reviewing lower risk protocols under exempt and/or expedited procedures may be poised out of habit to see all research as inherently risky. 

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.