DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Human Subject Protection:

FDA’s Role in a System of Safeguards

Without studies of new drugs,

biologics and devices in clinical

trials, the development of new

health-care products would plummet; and without knowledgeable

and voluntary participants, clinical

trials would come to a halt. Both

for the health and safety of individual study participants and for

the integrity of the product development process, protection of human subjects in product studies is

highly important.

The Food and Drug Administration is one of four parties involved

in the oversight of clinical research into FDA-regulated products, providing a system that protects the rights and welfare of

study subjects. The parties include:

• The product sponsor monitors

the overall conduct of the study.

• An Institutional Review Board

(IRB) composed of physicians,

scientists, and other knowledgeable members, among other functions, reviews research to assure

the protection of human participants.

• The clinical investigator and

study staff make sure that participants understand what the study

will entail, including the potential

risks of the experiment, and make

sure that the study protocol is followed properly.

• The FDA, whose product reviews depend on the validity of

clinical trial data, oversees the entire system.

The FDA’s efforts to protect human subjects generally emphasize

education, training, and outreach

for clinical investigators and IRBs.

In addition, the FDA conducts

about 1,000 trial-associated inspections a year, several hundred

of which involve extensive interviews with IRB administrators and

examination of their records, procedures, and responsiveness to

participants’ concerns. Inspections

and audits carried out under this

bioresearch monitoring program

cover all of the parties involved in

clinical trials, including clinical

investigators, IRBs, product sponsors, study monitors, and contract

research organizations.

In recent years, oversight of human subject protection has become more essential than ever because of developments such as an

increase in the number of clinical

trials, proliferation of multi-site

clinical trials, emergence of new

technologies such as gene therapy,

and an increase in clinical studies

involving “vulnerable” populations, such as children.

The FDA is working with the

Office for Human Research Protections of the Department of

Health and Human Services to improve the system of human subject

protection. As part of this effort,

the department is developing better guidance to enhance the informed consent process and is

clarifying how to manage financial

interests of investigators and others involved in the clinical trials to

help ensure that research is conducted properly and its results are

analyzed and presented objectively.

For more information, call the

FDA’s Office for Good Clinical

Practice, 301-827-4000, or visit

the FDA Web site at www.fda.gov/

oc/gcp/.

Publication No. FS 01-11

FDA Web site: www.fda.gov

Revised February 2002

Emphasis on Good Clinical

Practices

The FDA requires that the biomedical research it regulates conforms to regulations for Good Clinical Practice (GCP),

which set standards for the design, conduct, performance, monitoring, auditing,

recording, analysis, and reporting of

clinical trials. Compliance with GCP ensures that the data and reported results

are credible and accurate and that the

rights, safety, and well-being of trial subjects are protected. The FDA’s focal

point for GCP issues arising in human

research trials regulated by the agency is

the Office for Good Clinical Practice

(OGCP), which is part of the FDA

Commissioner’s office. OGCP functions

include coordination of the FDA’s policies on clinical studies and human subject protection. The office also coordinates the FDA’s bioresearch monitoring

program, administers the agency’s Human Subject Protection/Good Clinical Practice Steering Committee and

plans and conducts outreach programs and training.