Tag: quality assurance

Bioethics News

Available for download: The Research Ethics Committee Assessment Toolkit (RECAT) is designed to facilitate evaluation of the operational needs of Research Ethics Committees (RECs) globally to inform local quality assurance and quality improvement efforts

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

Research Ethics Committee Assessment Toolkit (RECAT)

Available for download: The Research Ethics Committee Assessment Toolkit (RECAT) is designed to facilitate evaluation of the operational needs of Research Ethics Committees (RECs) globally to inform local quality assurance and quality improvement efforts

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.

Bioethics Blogs

The Ethical Imperialism of the NAS

The National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements has released the second part of its report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The new part includes a chapter on “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” While presenting valid critiques of the NRPM, the chapter ignores the voices of scholars in social sciences and the humanities. Its proposals are unlikely to be adopted, and if they were they would continue the half-century history of marginalizing those disciplines.

Yes, the NPRM has problems

The report identifies four main problems with the NPRM:

Several provisions of the proposed regulations have been identified as problematic. These include: (1) proposed changes relating to the definition and handling of biospecimens; (2) how determinations are made regarding whether certain types of research may be excluded from administrative or institutional review board consideration; (3) inconsistencies amongst the proposed changes; and (4) an absence of specifics for key deliverables… .

The omission of specifics on key tools and guidelines like the exemption determination tool, consent templates, and list of privacy safeguards is problematic; because the items are undefined at present, it is impossible to comment on their merit or utility prior to the issuance of the final rule. Furthermore, it is not possible to provide an accurate estimation of regulatory impact without a clear understanding of what compliance will involve.

All true.

But the NAS counterproposal is unrealistic

The report recommends

that Congress authorize, and the President appoint, an independent, free-standing national commission modeled on the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral 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

Publishing Research Ideas

The newest science journal on the block with several unique twists is Research Ideas and Outcomes (RIO) (http://riojournal.com/). RIO aims to publish a variety of outputs in the research cycle, not only the results of research. The journal will publish papers on ideas, proposals, methods, research results, and software. They also publish review articles, opinion pieces, data papers, software descriptions, workflows, data management plans, conference abstracts, single figure publications, project reports and much more. Their aim is to better use the efforts scientists spend on writing and evaluating research proposals and other products within the research cycle. RIO does have limits; they will not accept teaching lectures or materials, clinical trials, patient or other data that may be considered unethical, homeopathy, nuclear or bioweapons research, creationist or religiously motivated research, cryptozoology, and pseudoscience. The journal also has many other interesting aspects. While they are an open access journal, unlike others, they do not charge the typical high costs of thousands of dollars. The journal charges between 50 to a few hundred euros for most types of publications. Peer review is also optional and RIO relies on public scrutiny to promote transparent and public peer review. Expert driven peer review, typically done in most medical and science journals, however, can be done upon the author’s request. The typical review process for papers submitted to RIO includes several technical checks and an external pre-submission review from a colleague.

While all this sounds pretty good thus far, one of the major questions is whether scientists are willing to share good research ideas (Rabesandratana, 2015).

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

Alarmist Claims about Public Administration Research

Two scholars from the University of South Africa claim that more than one in four articles they sampled in two journals of public administration involved “research of a more than minimal risk level.” This claim appears to be based on a misunderstanding of U.S. regulations.

[Jacobus S. Wessels and Retha G. Visagie, “The Eligibility of Public Administration Research for Ethics Review: A Case Study of Two International Peer-Reviewed Journals,” International Review of Administrative Sciences, September 3, 2015, 0020852315585949, doi:10.1177/0020852315585949.]

The error appears in Table 2, on p. 11 of the article. The authors list the following categories of “potential benefit and risks of the data-collection methods or techniques used”:

  • Individual interviews as a data-collection method (greater than minimal risk)
  • Group interviews as a data-collection method (greater than minimal risk)
  • Observation as a data-collection method (no risk to greater than minimal risk)
  • Conceptual research (no risk)

Apparently, Wessels and Visagie believe that under U.S. definitions, all individual and group interviews should be regarded as greater than minimal risk. This is not correct.

Though the authors claim to be following the categories established by the U.S. regulations (p. 12), they have not consulted OPRR’s 1998 Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure, a list of the most common forms of minimal risk research. This list specifically includes “Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.”

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

Planned Parenthood, Tissue Donation, and American Politics: A Call to Separate the Debate in the Media

by Macey L. Henderson, JD and Brianna L. Doby

The controversy over Planned Parenthood seems to be as old as time in American politics, but now the public perception of donated tissue for medical research might be at stake. Most recently, a video surfaced alleging to show the Senior Director of Medical Services for Planned Parenthood engaging in what appears to be the buying and selling of tissue from fetuses to a start-up biotech firm. Let’s be clear: This is not the first attack on Planned Parenthood, nor will it be the last. However, this undercover investigative effort by the somewhat mysterious scientific Center for Medical Progress is a ripe opportunity to get the facts straight about the reality and current practice of donated tissue for research or transplantation in the United States. It is against federal law to buy or sell human tissue in the United States (42 U.S. Code § 289g–2 – Prohibitions regarding human fetal tissue). It is also legal, safe, ethical, and practical to pay for the transport of donated tissue for medical research.

Here are the facts:

  • The legal termination of a pregnancy can provide the opportunity for tissue donation to medical research.
  • Donated fetal tissue has been used in medical research since the 1930s, and was integral to the development of the polio vaccine (and the 1954 Nobel Prize in Medicine).
  • Facilities that recover tissue do so after they have obtained informed consent based on Best Practices for Biospecimen Resources.
  • Without donated tissue, biomedical research and innovation to save and heal serious medical conditions would be hindered.

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

Legislation Changes the Rules for Research Uses of Newborn Dried Bloodspots

By Avery Avrakotos, education and policy manager

In March, the Newborn Screening Saves Live Reauthorization Act of 2014 went into effect. The act, which is an extension of the Newborn Screening Saves Lives Act of 2008, reauthorizes nearly $20 million in funding and expands state-based infant screening programs. It also contains a controversial amendment that requires informed consent for any federally funded research activities using newborn dried bloodspots.

Infant screening programs have been in place in the United States for more than 50 years. The programs, which are mandatory in 48 states, test newborns for more than 30 serious, but treatable, genetic disorders by taking a small sample of blood through a heel prick at birth. Collected samples are placed onto a small piece of filtered paper, known as a Guthrie card, and sent to a laboratory for testing. Results are then shared with the infant’s physician and parents.

In many states, the cards have historically been retained after the initial screening and used for quality assurance purposes, program evaluation activities, and/or biomedical research. However, a provision in the Newborn Screening Saves Lives Act of 2014 may change that. An amendment, which was added to the legislation at the last minute, amidst pressure from privacy advocates, states:

Research on newborn dried blood spots shall be considered research carried out on human subjects meeting the definition of section 46.102(f)(2) of title 45, Code of Federal Regulations, for purposes of Federally funded research conducted pursuant to the Public Health Service Act until such time as updates to the Federal Policy for the Protection of Human Subjects (the Common Rule) are promulgated pursuant to subsection (c).

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 not be inclusive rather than exclusive when selecting abstracts for conferences?

The American Society for Bioethics and Humanities (ASBH)
is the leading U.S.-based society for many bioethicists and humanities
scholars. ASBH’s mission is to promote “
the exchange of ideas and fosters multidisciplinary, interdisciplinary,
and interprofessional scholarship, research, teaching, policy development,
professional development and collegiality among people engaged in clinical and
academic bioethics and the medical humanities.
” It achieves these goals
by stimulating discourse through meetings, developing its own publications and
even impacting policy and practice. One major achievement by ASBH is its
attempt to standardize the practice of clinical ethics consultations by
developing the
Core Competencies in
Health Care Ethics Consultation
now available as a second edition. A
second, equally important, achievement is ASBH’s annual meeting.

As with all annual conferences, ASBH has a call for
abstracts for individual presentations and panel sessions among other venues.
They have a process of peer review and selection for accepting abstracts either
for individual oral presentations, posters, panel sessions, program workshops, and
preconference workshops. What I have noticed is for the last two years, I have personally
not had anything accepted at the ASBH annual meeting. In fact, of the few other
times I have applied, I have only been accepted to present a poster. Being
Canadian and entering the field of bioethics around 2004, I believe I have
attended only two ASBH meetings, one of which was way back when ASBH had a
joint meeting with the Canadian Bioethics Society and the last one in 2010. I
do however submit similar abstracts of my research to other bioethics, science,
and medical conference which results in its acceptance for a talk or poster,
but this seems to be a rarer case at ASBH.

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

Residual Dried Blood and New Born Screening in Minnesota

Note: The Bioethics Program blog is moving to its new home on April 1, 2015. Be sure to change your bookmarks to http://bioethics.uniongraduatecollege.edu/blog/

by Courtney Jarboe, Bioethics Program Student

In Minnesota, residual dried blood (RDB) samples collected for newborn screening had been stored, retained, and used for research without parental consent. It had been presumed that the Minnesota Department of Health (MDH) had the statutory authority to do so. In 2011, the Minnesota Supreme Court ruled (in the case of Bearder v. Minnesota) that the newborn screening program was subject to the Genetic Privacy Act (2006) (pdf), which requires written consent for secondary uses of genetic information. This ruling led to revisions of newborn screening legislation and the destruction of 1.1 million newborn screening RDB samples. Since the legislative dust has settled, MDH has begun aggressive educational campaigns to rebuild trust and awareness between parents and healthcare providers in Minnesota and address information gaps in the public’s understanding of the newborn screening program and the associated research.

In February of this year, I received a letter from the Citizen’s Council for Health Freedom (CCHF), an organization that actively supported the nine families in Bearder v. Minnesota who sued to stop the use of RDB samples for research. (see image) The letter details CCHF’s concerns about the MDH newborn screening program. The letter also suggests that MDH can use the RDB and the associated child’s DNA without parent consent. Included with the letter were a letter addressed to MDH and a copy of the MDH ‘Directive to Destroy’ form.

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.