updated 7/12/2006 4:40:18 PM ET 2006-07-12T20:40:18

Federal rules protecting people who are subjects of scientific research should be extended to include prisoners, the Institute of Medicine said in a report released Wednesday.

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The U.S. Office for Human Research Protections oversees many federally funded studies involving human volunteers. But it does not have jurisdiction over research funded by the Bureau of Prisons and other federal, state or private organizations that support studies with prisoners.

That is unjustified, a panel convened by the Institute concluded. It said all research involving prisoners — whether in jail or on probation or parole — should be governed by uniform ethical standards and guidelines.

Just how many prisoners are participating in research programs was not known, however, since there is no database of research involving them, according to the Institute, a branch of the National Academy of Sciences. Such a database should be established, the report said.

“Humane, respectful treatment of all prisoners is a hallmark of decent society,” said Lawrence Gostin, associate dean and professor of law at Georgetown University Law Center in Washington and chairman of the committee that wrote the report.

“Our goal should be to promote rigorous, responsible research that has the potential to improve the well-being of prisoners and the general public, while taking great care to protect the health and human rights of study participants,” Gostin said in a statement.

Of concern were prisoners’ limited privacy, their inherently coercive living arrangements and often inadequate health care.

“They are among the most vulnerable human subjects of research,” he said.

Currently, prisoners taking part in medical studies are covered by rules enacted in the 1970s, the report noted.

Since those rules were adopted, the number of people in correctional institutions has increased nearly five times to almost seven million, the report said. That has increased crowding while access to programs, services and health care that might be needed by prisoners in experiments has not kept pace.

Also, the report said, the prison population includes an increasingly large number of people from racial minorities and people who have mental illnesses and communicable diseases.

For research to be ethical it must offer prisoners potential benefits that outweigh risks, the committee said.

It has long been questioned whether prisoners can make a free choice about participating in research programs. Voluntary, informed consent is a prerequisite and human research protection programs must ensure it, the report concluded.

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