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: What are the chances that your dad isn't your dad?

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

Obese British man in court fight for surgery

Jul 11, 2011

A British man weighing 22 stone (139 kilograms, 306 pounds) launched a court appeal Monday against a decision to refuse him state-funded obesity surgery because he is not fat enough.

2008 crisis spurred rise in suicides in Europe

Jul 08, 2011

The financial crisis that began to hit Europe in mid-2008 reversed a steady, years-long fall in suicides among people of working age, according to a letter published on Friday by The Lancet.

New food labels dished up to keep Europe healthy

Jul 06, 2011

A groundbreaking deal on compulsory new food labels Wednesday is set to give Europeans clear information on the nutritional and energy content of products, as well as country of origin.

Overweight men have poorer sperm count

Jul 04, 2011

Overweight or obese men, like their female counterparts, have a lower chance of becoming a parent, according to a comparison of sperm quality presented at a European fertility meeting Monday.

User comments : 0

More news stories

Melting during cooling period

(Phys.org) —A University of Maine research team says stratification of the North Atlantic Ocean contributed to summer warming and glacial melting in Scotland during the period recognized for abrupt cooling ...