• Government
• Profession
• Business
• Opinion
• Health

• Health reform
• H1N1
• P4P
• EMRs
• Medicare
• Liability
• AMA House
• » More

• Book Excerpt
• Business Pitch
• Meetings
• » More

• Contract Language
• Ethics Forum
• In the Courts
• Practice Management
• Technically Speaking
• » More

• Issue dates
• Regions
• Health plans
• Sections
• News briefs
• Columns
• Editorials
• Letters
• Writers
• Other years

• Search tips
• E-mail alert
• Radio
• RSS
• Mobile
• Subscribe
• Institutions
• Staff directory
• Advertising
• Permissions
• Reprints
• News media
• Site guide
• Useful links
• About
• Premium
• Contact

Accreditation plan would guard clinical study patients

A new report says a national, private accreditation system would provide added protection for participants of medical research studies.

By Damon Adams, amednews staff. May 28, 2001.

• PRINT|
• E-MAIL|
• RESPOND|
• REPRINTS|
• SHARE

A federal report released last month recommends that private accreditation be established to certify that research programs meet tough standards to protect human participants of medical studies.

The Institute of Medicine report said accreditation should be done by independent, nongovernmental agencies and that volunteers should be involved in the research oversight process.

"This will give research subjects the comfort of knowing that the researchers and the people who fund research are trying to achieve an ideal," said Mary Faith Marshall, PhD, professor of medicine and bioethics at Kansas University Medical Center. Dr. Marshall was a member of the committee that drafted the IOM report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs.

The call for accreditation was prompted by several recent problems within research programs, including the death of a human subject in a gene therapy experiment and the shuttering of some research programs after flaws were uncovered in the way research was conducted.

Such troubles sparked debate on medical research, led Congress to call for tighter regulations and prompted federal officials to examine ways to protect people in research studies.

Accreditation, the new IOM report cautions, is only one solution, and such programs should be tested as pilot projects for three to five years before being adopted for widespread use. Accreditation should apply to all research programs, including doctor's offices that conduct drug trials for companies, the report suggests. [...]