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TWENTY YEARS AGO.

THAT POLICY WAS REVISED SEVERAL TIMES

IN THE NEXT FIVE YEARS TO KEEP PACE WITH THE GROWING

AWARENESS OF THE NEED TO PROTECT THE RIGHTS AND WELFARE OF

RESEARCH SUBJECTS. IN 1971 IT WAS ISSUED AS A DEPARTMENT-WIDE POLICY FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS. IN

THE THREE YEAR PERIOD FOLLOWING THE PROMULGATION OF THE

1971 POLICY, THE SENATE HEALTH SUBCOMMITTEE HELD HEARINGS

TWO OR THREE TIMES EACH YEAR ON ISSUES RELATING TO THE

APPLICATION OF THE POLICY TO DIFFICULT CASES. THESE HEARINGS
CULMINATED IN THE NATIONAL RESEARCH ACT OF 1974 WHICH
REQUIRED THE DEPARTMENT--THEN HEALTH, EDUCATION AND

WELFARE--TO PROMULGATE REGULATIONS FOR THE PROTECTION OF

HUMAN SUBJECTS.

ALTHOUGH THE NATIONAL RESEARCH ACT WAS

NOT SIGNED UNTIL JULY 12, 1974, THE DEPARTMENT ANTICIPATED
THE REQUIREMENTS OF THE ACT AND ON MAY 30, 1974, ISSUED

THE FIRST SET OF REGULATIONS FOR THE PROTECTION OF HUMAN

SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH:

THE NATIONAL RESEARCH ACT OF 1974 NOT ONLY REQUIRED

PROMULGATION OF REGULATIONS BUT ALSO ESTABLISHED THE NATIONAL
COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL

AND BEHAVIORAL RESEARCH.

THAT COMMISSION BEGAN ITS WORK

IN DECEMBER OF 1974 AND CONTINUED TO HOLD MONTHLY MEETINGS

FOR THE NEXT FOUR YEARS.

AT LEAST ONE PORTION OF EACH OF

THE MEETINGS WAS DEDICATED TO A PUBLIC HEARING AT WHICH

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WITNESSES FROM ALL SEGMENTS OF SOCIETY WERE ENCOURAGED

TO PRESENT THEIR VIEWS AS TO HOW HUMAN SUBJECTS SHOULD

BE PROTECTED.

THE COMMISSION ISSUED A SERIES OF REPORTS

DEALING WITH SUCH ISSUES AS PROTECTIONS FOR PREGNANT

WOMEN, FETUSES, CHILDREN, AND PRISONERS.

IT ISSUED A

REPORT ON INSTITUTIONAL REVIEW BOARDS (IRBs), WHICH

INCLUDED A SECTION DEALING WITH INFORMED CONSENT.

FINALLY,

AND PERHAPS MOST IMPORTANT, IT PUBLISHED A FLEXIBLE SET OF

ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF

HUMAN SUBJECTS OF RESEARCH IN A PUBLICATION POPULARLY

CALLED THE BELMONT REPORT.

IN 1979, AFTER THE COMMISSION

HAD FINISHED ITS WORK, THE DEPARTMENT OF HEALTH AND

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OF HUMAN SUBJECTS IN 1981, THE DEPARTMENT REVIEWED APPROX-
IMATELY 700 SETS OF PUBLIC COMMENTS ON COMMISSION REPORTS

AND THE PROPOSED RULES AND IT HELD THREE PUBLIC HEARINGS.

DRAFTS OF THE FINAL RULES WERE REVIEWED BY THE PRESIDENT'S

COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND

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PERMISSION, MR. CHAIRMAN, I WOULD LIKE TO SUBMIT FOR THE

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IS ELIGIBLE TO RECEIVE AN AWARD FROM THE DEPARTMENT OF

HEALTH AND HUMAN SERVICES FOR RESEARCH INVOLVING HUMAN

SUBJECTS, IT MUST SUBMIT AN ASSURANCE DOCUMENT ACCEPTABLE

TO THE DEPARTMENT. THAT DOCUMENT SETS FORTH THE ADMIN

ISTRATIVE STRUCTURE WHICH THE INSTITUTION HAS IN PLACE

FOR PROTECTING HUMAN SUBJECTS.

THE CENTRAL FEATURE OF

THAT STRUCTURE IS AN INSTITUTIONAL REVIEW BOARD (IRB)

COMPOSED OF A VARIETY OF INDIVIDUALS SELECTED BECAUSE

THEY ARE WELL QUALIFIED TO REVIEW RESEARCH AND TO COMMAND

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AMONG ITS DUTIES, THE IRB MUST DETERMINE THAT ANY RISKS

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ASSOCIATED WITH THE RESEARCH ARE MINIMIZED AND REASONABLE

IN THE LIGHT OF ANTICIPATED BENEFITS TO THE SUBJECT AND

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AND APPROVE AN INFORMED CONSENT DOCUMENT, A COPY OF WHICH

MUST BE PROVIDED TO AND SIGNED BY THE POTENTIAL SUBJECT

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3. A DESCRIPTION OF ANY BENEFITS TO THE SUBJECT OR TO

OTHERS WHICH MAY REASONABLY BE EXPECTED FROM THE

RESEARCH;

4.

A DISCLOSURE OF APPROPRIATE ALTERNATIVE PROCEDURES

OR COURSES OF TREATMENT, IF ANY, THAT MIGHT BE

ADVANTAGEOUS TO THE SUBJECT;

5.

A STATEMENT DESCRIBING THE EXTENT, IF ANY, TO WHICH

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AVAILABLE IF INJURY OCCURS AND, IF SO, WHAT THEY

CONSIST OF, OR WHERE FURTHER INFORMATION MAY BE

OBTAINED;

7. AN EXPLANATION OF WHOM TO CONTACT FOR ANSWERS TO

PERTINENT QUESTIONS ABOUT THE RESEARCH AND RESEARCH

SUBJECTS' RIGHTS, AND WHOM TO CONTACT IN THE EVENT

OF A RESEARCH-RELATED INJURY TO THE SUBJECT; AND

8.

A STATEMENT THAT PARTICIPATION IS VOLUNTARY,

REFUSAL TO PARTICIPATE WILL INVOLVE NO PENALTY OR

LOSS OF BENEFITS TO WHICH THE SUBJECT IS OTHERWISE

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