Tag: consent forms

Bioethics Blogs

Good Death, or Assisted Suicide?

The Case of Mr. Perry and his Pacemaker

Tarris Rosell, PhD, DMin
Rosemary Flanigan Chair at the Center for Practical Bioethics

NOTE: Dr. Rosell, a bioethics consultant and educator, will present the case of Mr. Perry for ethics discussion and likely debate on Thursday, June 22, 2017 at 7:00 PM in the artfully rebuilt Westport Presbyterian Church, 201 Westport Rd, Kansas City, MO. Bring your perspectives, arguments, and personal stories of moral medical dilemma. Admission is free. All are invited and welcome.

Mr. Perry (not his real name) was 83 years old and had several medical problems. He had spent the past several months in and out of hospitals and rehab. Prior to that, he lived independently in a small Midwestern town. Widowed many years ago, he subsequently enjoyed the company of a lovely lady friend who lived down the street from the Perry home. He had five adult children and numerous grandchildren.

Life should have been relatively good for this octogenarian. But life was not good. Not anymore. “My body is all worn out. I’m worn out. Don’t want to do this anymore, Doc. They say I can’t go home and be safe. And I’m NOT going to a nursing home. No way! Just stop that little gadget that shocks me and the part that keeps my heart going. I want them stopped. Yes, the pacemaker, too. A magnet will stop it, right? Just do it. Please.”

Tired of Fighting

Mr. Perry had a cardiac resynchronization therapy defibrillator (CRT-D) implanted a few years ago. It included an electrical pacing component for heart rhythms, on which the patient was 100% dependent.

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 Unusual Case of Ian Paterson and Criminally Harmful Surgery

Guest post by Alex Mullock, University of Manchester

On 28th April 2017 in the case of breast surgeon, Ian Paterson, the jury in Nottingham Crown Court agreed that in carrying out unnecessary and mutilating surgery the defendant had done what no reasonable surgeon would do.  Paterson was convicted of seventeen counts of wounding with intent to cause grievous bodily harm (GBH) and three counts of unlawful wounding (under, respectively, sections 18 and 20 of the Offences Against the Person Act 1861) against nine women and one man. These ten victims, however, have been reported to represent a tiny proportion of all Paterson’s alleged victims, a group that might amount to hundreds from his many years of practice in the NHS and private sector.

The “obscure motives” that compelled Paterson may forever remain a mystery but it is interesting that the charges against him relate only to patients he treated in his private practice.  This enabled the prosecution to create a narrative that suggested that financial gain could have been the motivating factor for Paterson’s crimes.  Without greed as a possible motive his actions are baffling, and the prosecution’s case, in alleging that surgery which Paterson argued was performed in the patient’s best interests actually constituted GBH or unlawful wounding, would be more challenging because of the medical context of the allegations.  Importantly, the medical exception to the criminal law – the principle that consensual surgery carried out by qualified professionals is legitimate (“proper medical treatment”) – means that there is an assumption that harm caused by surgery is not a matter for the criminal law because it is a risk that we accept in order to enjoy the benefits of surgical medicine.

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

Regenerative Medicine: The Promise and Peril

Caption: Scanning electron micrograph of iPSC-derived retinal pigment epithelial cells growing on a nanofiber scaffold (blue).
Credit: Sheldon Miller, Arvydas Maminishkis, Robert Fariss, and Kapil Bharti, National Eye Institute/NIH

Stem cells derived from a person’s own body have the potential to replace tissue damaged by a wide array of diseases. Now, two reports published in the New England Journal of Medicine highlight the promise—and the peril—of this rapidly advancing area of regenerative medicine. Both groups took aim at the same disorder: age-related macular degeneration (AMD), a common, progressive form of vision loss. Unfortunately for several patients, the results couldn’t have been more different.

In the first case, researchers in Japan took cells from the skin of a female volunteer with AMD and used them to create induced pluripotent stem cells (iPSCs) in the lab. Those iPSCs were coaxed into differentiating into cells that closely resemble those found near the macula, a tiny area in the center of the eye’s retina that is damaged in AMD. The lab-grown tissue, made of retinal pigment epithelial cells, was then transplanted into one of the woman’s eyes. While there was hope that there might be actual visual improvement, the main goal of this first in human clinical research project was to assess safety. The patient’s vision remained stable in the treated eye, no adverse events occurred, and the transplanted cells remained viable for more than a year.

Exciting stuff, but, as the second report shows, it is imperative that all human tests of regenerative approaches be designed and carried out with the utmost care and scientific rigor.

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 social scientist’s guide to the Final Rule

On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a huge victory for historians, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.

In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.

No biospecimens overhaul; less controversy

The final rule “does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.” This was the target of the greatest criticism from groups like the National Academies of Sciences, Engineering, and Medicine and SACHRP. So while this change has little direct bearing on the work of social scientists and scholars in the humanities, it will likely reduce the controversy surrounding the regulatory reform as a whole.

The abandonment of the biospecimens proposal could also reduce opposition to reform by conservatives. The House Freedom Caucus opposed a new Common Rule on the grounds that it would cost $13.334 billion over 10 years. This figure seems to have been drawn from the NPRM’s quantified costs of $13.342 billion (using a 3 percent discount rate), and ignored the NPRM’s quantified benefits of $2.6 billion. If all the Freedom Caucus cares about is money, it may like the final rule a lot more.

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

New Common Rule Regs Mean New Training for IRB Members

by Craig Klugman, Ph.D.

Yesterday, the Department of Health & Human Services released the long-awaited, and debated, new Common Rule. Many of the proposals that were released in earlier versions for public comment did not make their way into the rule. All IRB members will also need to undergo training to incorporate the new rules into their reviews. Most of the changes have a deadline of 1 year (January 2018) for enactment.

Though many experts in research ethics will be writing on this in great detail, I offer a brief synopsis of the changes here. However, keep in mind that the incoming administration has suggested they may rollback all executive orders made by the Obama administration in its last few months, if not during the entire Obama presidency. Thus, it is possible that these rule changes are rolled back very quickly.

Who is covered?

The new rules maintain that only federally funded clinical trials must be reviewed by an IRB.

New Definitions

For the first time, the rules adopt a definition of Clinical Trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” The new rules also offer separate definitions of “identifiable biospecimen” and “identifiable private information,” whereas previously, both were defined together.

Some definitions were tweaked (e.g. “private information”) and others remain unchanged (e.g. “human subject”).

Biobanking specimens and information

One of the most controversial proposed changes was that of having to gain subject consent for use of banked specimens.

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

Inside the Lab that Grows Human Skin to Test your Cosmetics

Patients may not even know where to look given that consent forms—part of the standard hospital admissions paperwork—don’t usually specify how tissue will be used. It could go to a patient’s doctor or to a researcher at another university or to a company. “There’s a lot about how research is conducted in the US that the public doesn’t understand,” says Michelle Lewis, a bioethicist at Johns Hopkins Berman Institute of Bioethics

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

Reforms for “21st century science” would have been good for the 20th too

A group of 11 researchers and IRB professionals, most of them affiliated with the University of California, San Diego, report on a brainstorming session from early 2015. They argue that readable consent forms, expert review, a less punitive system, and more exemptions would better serve researchers and participants. While they present their ideas as “a human research protections system that is responsive to 21st century science,” the measures they propose are equally valid for research as it has been practiced for decades.

[Cinnamon Bloss et al., “Reimagining Human Research Protections for 21st Century Science,” Journal of Medical Internet Research 18, no. 12 (2016): e329, doi:10.2196/jmir.6634.]

Five recommendations

The team presents its proposals under five headings, but I see the second and fifth as similar in intent.

  • Redesigning the Consent Form and Process

There’s broad consensus that written consent forms often fail to give prospective research participants the information they need to make a good decision. The UCSD team proposes consent forms based on Creative Commons licenses (like the one used by this blog). “Research studies,” they explain, “could create three consent forms: one that contains all the legalese and scientific exposition; one in plain English that presents the facts; and a third that is simplified even further and presents risks in bullet point format.”

  • Empowering Researchers to Protect Participants

Though the authors call for “empowering researchers,” really they are calling for expert peer review:

Researchers intending to engage in human-participant research could produce a document that lays out plans and risks of the research. They could then offer those documents, along with an outline of the proposed consent process, for review by their peers.

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

Religious exemptions to assisted dying harm patients

Stuart Chambers argues that faith-based institutions should not be ‘conscientiously objecting’ to medical assistance in dying.

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Since the passing of Bill C-14 “An Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying),” the debate over negative and positive rights has resurfaced. Assisted dying advocates emphasize negative rights. They insist that the state should refrain from interfering in the intimate personal decisions of its citizens. However, they also make claims about positive rights insofar as the state has an obligation to provide the resources—hospitals, staff, drugs—required to fulfill a dignified death. Without both types of rights — negative and positive — the Act is groundless. When faith-based hospitals demand religious exemptions from medical assistance in dying, they are, thereby, undermining personal dignity. The result is increased vulnerability and suffering for patients.

For reasons of conscience, individual health care professionals may refrain from providing end-of-life services. There is nothing in the Act, however, that remotely suggests that publicly-funded hospitals are exempt from the responsibility to provide medical assistance in dying.  This has not stopped faith-based institutions from imposing their theological worldview on their patients. In December 2015, the Catholic Health Sponsors of Ontario rejected any exception for physician-assisted death in its institutions and would not “directly or explicitly” refer a patient to get the medical procedure elsewhere.

Concordia Hospital

This religious bias, however, was not in sync with the attitudes of Ontarians. When polled in October 2016, 57% of Ontario residents disapproved of the position of Catholic hospitals on medical assistance in dying.

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

Calls for Ethical Pluralism

In separate essays, Nathan Emmerich and Igor Gontcharov argue for more flexible systems that would avoid imposing biomedical ethics on the social sciences. Emmerich calls for an emphasis on professional ethics, while Gontcharov seeks “a set of ethical principles that would better reflect the position of [social sciences and humanities] researchers and participants.” I am left unsure what either proposed reform would look like in practice.

[Nathan Emmerich, “Reframing Research Ethics: Towards a Professional Ethics for the Social Sciences,” Sociological Research Online 21, no. 4 (2016): 7, DOI: 10.5153/sro.4127; Igor Gontcharov, “A New Wave of Positivism in the Social Sciences: Regulatory Capture and Conceptual Constraints in the Governance of Research Involving Humans,” SSRN Scholarly Paper (Rochester, NY: Social Science Research Network, October 31, 2016), DOI: 10.2139/ssrn.2861908.]

Emmerich seeks professional ethics

Emmerich argues that

the social sciences can lay claim to a democratic ideal as its ‘higher good’ and, therefore, its guiding ethos or end… .

Given this end – democracy – social science research is persuaded not for its own sake or for the sake of knowledge in itself. Rather, its pursuit is rooted in the (admittedly diverse) socio-political needs of ‘democracy,’ understood as an ethos or normative as an end in itself.

Because of the importance of this work, he argues, researchers should not be constrained by ethics committees. Instead, he proposes that social scientists be judged by the equivalent of clinical ethics committees (CECs), which Emmerich describes as

forums healthcare professionals can attend in order to discuss any ethical issues they encounter.

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

Visiting Your Leg

From morbid anatomy museums to modern consent forms, medicine wants ever more control over your body – and its parts

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.