RSO News
May 2002

CLINICAL RESEARCH STILL UNDER ATTACK IN POPULAR PRESS. Articles lamenting or criticizing protections of human research subjects have appeared in major newspapers with regularity for the past few years. Last month, the Time magazine cover story was titled "Human Guinea Pigs." <http://www.time.com/time/covers/1101020422/> Side stories were titled "They're Dying to Get In," "Poisoning for Dollars," "Questions to Ask Your Doctor," "History: A Look at Past Abuse," and "How Clinical Trials Are Supposed to Work." Clinical investigators need to be aware of the media’s influence in the possible erosion of public support for biomedical research, in general, and clinical research, in particular.

HOW WELL INFORMED ARE RESEARCH VOLUNTEERS? The level of understanding of the research in which they participate was assessed in a recent survey of 1,561 clinical trial volunteers performed by CenterWatch. Incomplete information held by volunteers was uncovered in several areas:

Not understanding that a volunteer can quit a study at any time     11%

Not understanding that a study would carry additional risks and discomfort     30%

Not knowing the number of visits to the study doctor     15%

Not understanding that neither the doctor nor the volunteer would know what medication the participant was receiving during the study     37%

Not having all questions answered     16%

Since the goal would be 0% lack of understanding, there is room for improvement in the consent process. The study also revealed that 83% of volunteers made the decision to participate on their own. The remaining 17% consulted their personal physician (30%), family members (30%), the study nurse (9%), or a friend (9%) to assist them with their decision to volunteer.

DR. GREG KOSKI, OHRP DIRECTOR, ISSUES “OPEN LETTER TO THE HUMAN RESEARCH COMMUNITY.” The director of the Office for Human Research Protections (OHRP) of DHHS has challenged institutions to participate in a voluntary quality improvement program. Specific details of the combined Quality Assurance, Quality Improvement, and Continuous Quality Improvement Program can be found at http://ohrp.osophs.dhhs.gov/humansubjects/qip/qip.htm. Although currently being developed as a voluntary process, many observers predict that obligatory accreditation of IRBs and even investigators (see below) will soon follow.

CERTIFICATION PROGRAM FOR CLINICAL INVESTIGATORS. The Association of Clinical Research Professionals (ACRP), an organization whose education programs previously focused on research coordinator and clinical research associates, has begun a certification program for clinical investigators. The second offering of the exam will be November 9 at 25 locations. More information is available form Paul Groth (paul@acrpnet.org) or the general ACRP website <http://www.acrpnet.org/index.html>.

RSO STAFF CHANGES. Vania Brightman has joined the RSO as a senior office specialist.