HB269 (2005) Detail

Establishing a statutory committee for the protection of human research subjects.


CHAPTER 183

HB 269 – FINAL VERSION

05/26/05 1579s

2005 SESSION

05-0705

01/04

HOUSE BILL 269

AN ACT establishing a statutory committee for the protection of human research subjects.

SPONSORS: Rep. MacKay, Merr 11; Rep. Pilliod, Belk 5; Rep. Emerton, Hills 7; Rep. Batula, Hills 19; Sen. Martel, Dist 18

COMMITTEE: Health, Human Services and Elderly Affairs

ANALYSIS

This bill establishes a statutory committee for the protection of human subjects. The committee shall have, at a minimum, 7 members who shall be appointed by the commissioner of the department of health and human services. The commissioner is granted rulemaking authority for the purposes of the bill.

This bill is a request of the department of health and human services.

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Explanation: Matter added to current law appears in bold italics.

Matter removed from current law appears [in brackets and struckthrough.]

Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.

05/26/05 1579s

05-0705

01/04

STATE OF NEW HAMPSHIRE

In the Year of Our Lord Two Thousand Five

AN ACT establishing a statutory committee for the protection of human research subjects.

Be it Enacted by the Senate and House of Representatives in General Court convened:

183:1 New Sections; Committee for the Protection of Human Subjects. Amend RSA 171-A by inserting after section 19 the following new sections:

171-A:19-a Committee for the Protection of Human Subjects.

I. There is hereby established within the department an institutional review board which shall be known as the committee for the protection of human subjects. The committee shall oversee research conducted in department-funded programs that serve people with mental illness, developmental disabilities, and substance abuse or dependence disorders. No research shall be conducted in these programs until it has been reviewed and approved by the committee.

II. The committee shall have, at a minimum, 7 members with varying backgrounds to promote complete and adequate review of research activities. The commissioner shall appoint the members. The committee shall be sufficiently qualified through the experience, expertise, and diversity of its members to promote respect for its advice and counsel in protecting human subjects in research and safeguarding the privacy and confidentiality of medical records information that is used for the purposes of research. In addition to possessing the professional competence necessary to review specific research activities, the committee shall be able to ascertain the acceptability of proposed research in terms of applicable laws and regulations and standards of professional conduct and practice. The committee shall therefore include persons knowledgeable in these areas. Members of the committee shall be appointed to 3-year terms.

III. The committee shall include at least one member whose primary area of expertise is scientific and one member whose primary area of expertise is non-scientific.

IV. The committee shall include at least 2 members who are not otherwise affiliated with the department and who are not part of the immediate family of a person who is affiliated with the department.

V. The committee shall include at least 2 members who are consumers or family members of consumers.

VI. No member of the committee shall participate in initial or continuing review of any research project in which the member has a conflicting interest, except to provide information requested by the committee.

VII. The committee may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that possessed by the members of the committee. These individuals may only offer advice and guidance and shall not participate in the decision as to whether or not to approve the research.

VIII. The committee shall choose a chairperson and vice-chairperson from its membership. The commissioner may assign department staff to assist the committee as needed.

171-A:19-b Rulemaking. The commissioner may adopt rules, pursuant to RSA 541-A, relative to the operation of the committee for the protection of human subjects, established in RSA 171-A:19-a, and the procedures, conditions, and criteria for the conduct and approval of research.

183:2 Effective Date. This act shall take effect 60 days after its passage.

(Approved: June 30, 2005)

(Effective Date: August 29, 2005)

Links

HB269 at GenCourtMobile

Action Dates

Date Body Type

Bill Text Revisions

HB269 Revision: 8743 Date: Jan. 21, 2010, midnight

Docket