Individuals have a right to participate in risky research trials, which might harm their health or even kill them

Patient participation in high-risk research could benefit novel drug trials

Published on September 19, 2013 at 2:47 AM         ·

Individuals have a right to participate in risky research trials, which might harm their health or even kill them, and institutional review boards (known as research ethics committees in the UK) – which are responsible for deciding whether a particular research trial can take place in a given institution – are potentially impeding the progress of research by rejecting such studies on ethical grounds, according to a Viewpoint published in The Lancet today [Wednesday 18 September].

Dr David Shaw, of the Institute for Biomedical Ethics, at the University of Basel, Switzerland, argues that “Institutional review boards should never reject a study because it poses too high a risk to participants, and that their role should be confined to ensuring that risks and any potential benefits are fully explained to potential participants. Everyone should have the right to participate in research without paternalistic decisions about risk being made on their behalf.”

It has been argued that patients who participate in trials – particularly those who are terminally ill – are often under what is termed “the therapeutic misconception”, whereby they wrongly believe that they will benefit from participation in a study, even if they are told they might not. Ethics committees frequently deny approval for trials where patients are seen as unlikely to benefit from treatment offered during the trial.

However, Dr Shaw argues that instead of this overly paternalistic approach, institutional review boards should instead ensure that trial participants fully understand the risks involved, and if they still want to take part, they should not be prevented from doing so. Furthermore, he suggests that relaxing attitudes towards patient participation in risky research could greatly benefit some research programmes, particularly for novel drugs where, in the early stages of development, trials are often difficult or impossible to approve, because of uncertainty about prospective harm or benefit.

“Why potential participants should be denied the opportunity to participate in trials that pose even higher risks if they wish to do so, is unclear,” says Dr Shaw. “Competent adults can, for example, go skydiving, potholing, or bungee jumping. All of these sports are highly dangerous and, unlike research, confer no benefit to society. For example, skydivers have a one in 100 000 risk of death at each jump, and the injury rate is about one in 200. Almost half of bungee jumpers sustain at least minor injury. Why should people not be allowed to run similar or higher risks by participating in societally beneficial clinical research? Although a lot less fun, and also potentially fatal, participation in such research has the potential to help people and demonstrates solidarity with one’s community.”

“To stop people participating in high-risk research denies them the right to help their communities, patients worldwide, and future generations of patients…Assisted dying is increasingly regarded as acceptable in many developed countries; if healthy people are allowed to participate in high-risk sports that might kill them, and sick people can be assisted in ending their lives, why should both groups not be able to risk dying in a way that potentially benefits society?”



Documentary Evidence Reveals Motives of Pharmaceutical “Seeding” Trials

Re-Post for filing 2008

Clinical studies that are designed by pharmaceutical companies to promote use of their drugs are called “seeding” trials. While much has been written about the marketing tactics of the pharmaceutical industry, seeding trials have not been characterized in depth. A new study finds strong documentary evidence of how a pharmaceutical company framed a marketing effort as a clinical trial. Researchers reviewed internal documents that became public during litigation against the drug manufacturer. The company’s marketing division designed the trial, and handled all collection, analysis, and dissemination of data. The company hid their motive for the trial from participants, investigators, and institutional review board members. Researchers concluded that seeding trials are harmful for three reasons: First, because the company disguises its motives, informed consent is impossible; second, good quality research is at risk when marketers – rather than scientists – design a study; and third, the scientific question posed by a seeding trial often has little merit. An accompanying editorial warns institutional research review boards to avoid approving seeding trials and physicians to avoid enrolling their patients in them

Single dose of hallucinogen may create lasting personality change – psilocybin

Johns Hopkins study of ingredient in ‘magic mushrooms’ found participants exhibited more ‘openness’

A single high dose of the hallucinogen psilocybin, the active ingredient in so-called “magic mushrooms,” was enough to bring about a measureable personality change lasting at least a year in nearly 60 percent of the 51 participants in a new study, according to the Johns Hopkins researchers who conducted it.

Lasting change was found in the part of the personality known as openness, which includes traits related to imagination, aesthetics, feelings, abstract ideas and general broad-mindedness. Changes in these traits, measured on a widely used and scientifically validated personality inventory, were larger in magnitude than changes typically observed in healthy adults over decades of life experiences, the scientists say. Researchers in the field say that after the age of 30, personality doesn’t usually change significantly.

“Normally, if anything, openness tends to decrease as people get older,” says study leader Roland R. Griffiths, a professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine.

The research, approved by Johns Hopkins’ Institutional Review Board, was funded in part by the National Institute on Drug Abuse and published in the Journal of Psychopharmacology.

The study participants completed two to five eight-hour drug sessions, with consecutive sessions separated by at least three weeks. Participants were informed they would receive a “moderate or high dose” of psilocybin during one of their drug sessions, but neither they nor the session monitors knew when.

During each session, participants were encouraged to lie down on a couch, use an eye mask to block external visual distraction, wear headphones through which music was played and focus their attention on their inner experiences.

Personality was assessed at screening, one to two months after each drug session and approximately 14 months after the last drug session. Griffiths says he believes the personality changes found in this study are likely permanent since they were sustained for over a year by many.

Nearly all of the participants in the new study considered themselves spiritually active (participating regularly in religious services, prayer or meditation). More than half had postgraduate degrees. The sessions with the otherwise illegal hallucinogen were closely monitored and volunteers were considered to be psychologically healthy

“We don’t know whether the findings can be generalized to the larger population,” Griffiths says.

As a word of caution, Griffiths also notes that some of the study participants reported strong fear or anxiety for a portion of their daylong psilocybin sessions, although none reported any lingering harmful effects. He cautions, however, that if hallucinogens are used in less well supervised settings, the possible fear or anxiety responses could lead to harmful behaviors.

Griffiths says lasting personality change is rarely looked at as a function of a single discrete experience in the laboratory. In the study, the change occurred specifically in those volunteers who had undergone a “mystical experience,” as validated on a questionnaire developed by early hallucinogen researchers and refined by Griffiths for use at Hopkins. He defines “mystical experience” as among other things, “a sense of interconnectedness with all people and things accompanied by a sense of sacredness and reverence.”

Personality was measured on a widely used and scientifically validated personality inventory, which covers openness and the other four broad domains that psychologists consider the makeup of personality: neuroticism, extroversion, agreeableness and conscientiousness. Only openness changed during the course of the study.

Griffiths says he believes psilocybin may have therapeutic uses. He is currently studying whether the hallucinogen has a use in helping cancer patients handle the depression and anxiety that comes along with a diagnosis, and whether it can help longtime cigarette smokers overcome their addiction.

“There may be applications for this we can’t even imagine at this point,” he says. “It certainly deserves to be systematically studied.”


Along with the National Institute on Drug Abuse, this study was funded by the Council on Spiritual Practices, Heffter Research Institute and the Betsy Gordon Foundation.

Other Hopkins authors of the research include Matthew W. Johnson, Ph.D, and Katherine A. MacLean, Ph.D.

Johns Hopkins Medicine Media Relations and Public Affairs Media Contact: Stephanie Desmon 410-955-8665