Clinical trials: Comprehension unaffected by simplified consent forms or payment

Aug 10, 2010

Although informed consent is an ethical cornerstone in research with humans, some studies suggests that volunteers often do not understand key aspects of the research in which they participate. Recent efforts have been made to improve informed consent by simplifying the consent forms.

A new study refutes two common assumptions about consent forms: that the length and complexity of forms affect comprehension and that people who are paid to enroll in research may be "blinded by money" and thus ignore key details of the study.

In a randomized controlled trial of a standard versus concise consent form for a low-risk phase I bioequivalence study of a marketed drug, the authors found that overall comprehension was comparable - and high - with both forms. Furthermore, the shorter form appeared to have no adverse effect on the quality of informed consent. Another intriguing finding was that comprehension was slightly higher among the paid volunteers than those who were unpaid. And, the study revealed that the overall comprehension scores of socioeconomically disadvantaged participants was good, negating the common claim that this population of research participants requires special protections.

The report of the study appeared in IRB: Ethics & Human Research, published by The Hastings Center. The authors include two Hastings Center Fellows and bioethics leaders in the federal government: Ezekiel Emanuel, head of the Department of Bioethics at the National Institutes of Health Clinical Center and special advisor for health policy to the director of the White House Office of Management and Budget; and Christine Grady, acting chief of the Department of Bioethics at the NIH Clinical Center and a member of the Presidential Commission for the Study of Bioethical Issues. Other authors are Leanne Stunkel and Ninet Sinaii, of the NIH Department of Bioethics; and Meredith Benson, Louise McLellan, and Garbriella Bedarida, of Pfizer.

Although informed consent is an ethical cornerstone in research with humans, some studies suggest that volunteers often don't understand key aspects of the research. Recent efforts have been made to improve informed consent by simplifying the consent forms. A new study refutes two common assumptions about consent forms: that the length and complexity of forms affect and that people who are paid to enroll in research may be "blinded by " and thus ignore key details of the study.

Explore further: Amgen misses 1Q views as higher costs cut profit

Provided by The Hastings Center

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Consent forms for research: Have they improved in 25 years?

May 28, 2010

The consent forms that people sign before participating in research are widely considered difficult to understand and sometimes inaccurate. The lack of clarity was implicated in a high-profile legal settlement in April between ...

Patient consent forms should educate not intimidate

Dec 17, 2008

It's time patient consent forms came back full circle to a tool for patient education, rather than the waiver of liability they have become. The original purpose of the consent forms was for a surgeon or doctor to inform ...

Ways to improve informed consent are testable, study says

Jan 11, 2008

New ways to make sure people are adequately informed about the risks and benefits of taking part in a clinical trial can be field-tested for effectiveness as vigorously as new medical treatments themselves, a study led by ...

Intimate examinations should not be performed without consent

Jun 20, 2008

[B]Editorial: Informed consent and intimate examinations[/B] Intimate examinations, performed by medical students on anaesthetised patients, are often carried out without adequate consent from patients, but this violates the ...

Bioethicist: Egg donors should be paid

Aug 10, 2006

A U.S. bioethicist says women who donate their eggs for stem cell research should be compensated, as are other healthy research volunteers.

Recommended for you

Amgen misses 1Q views as higher costs cut profit

21 hours ago

Despite higher sales, biotech drugmaker Amgen's first-quarter profit fell 25 percent as production and research costs rose sharply, while the year-ago quarter enjoyed a tax benefit. The company badly missed ...

Valeant, Ackman make $45.6B Allergan bid

Apr 22, 2014

Valeant Pharmaceuticals and activist investor Bill Ackman have unveiled details of their offer to buy Botox maker Allergan, proposing a cash-and-stock deal that could be worth about $45.6 billion.

User comments : 0

More news stories

Cyber buddy is better than 'no buddy'

A Michigan State University researcher is looking to give exercise enthusiasts the extra nudge they need during a workout, and her latest research shows that a cyber buddy can help.

Man among first in US to get 'bionic eye' (Update)

A degenerative eye disease slowly robbed Roger Pontz of his vision. Diagnosed with retinitis pigmentosa as a teenager, Pontz has been almost completely blind for years. Now, thanks to a high-tech procedure ...