Protect People in Medical Research

Section 1. Section 2441 of the public health law is amended by adding ten new subdivisions 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 to read as follows:

7. "Minimal risk" means the risks of harm anticipated in the proposed human research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

8. "Greater than minimal risk" means that the risks of harm anticipated in the proposed human research exceed the risks of harm associated with minimal risk human research.

9. "Possibly therapeutic human research" is human research which a human research review committee has determined holds out a prospect of direct benefit and is important to the health or well being of the patient and is only available in the context of the human research to be conducted.

10. "Non-therapeutic human research" is all human research which is not possibly therapeutic human research.

11. "Mental disorder that may affect decision making capacity" means any disorder that alters mental activity, including but not limited to, mental retardation, dementia, bipolar disorder, substance abuse disorder, and any other condition or behavior that calls a person's decision making capacity into question.

12. "Research advance directive" means a written advance directive, executed by an individual with the capacity to do so, that states a desire of the individual to participate in research in specific risk/benefit categories.

13. "Research agent" means a legally authorized representative to whom authority to make research decisions is delegated under a research

EXPLANATION--Matter in italics (underscored) is new; matter in brackets

[ ] is old law to be omitted.

LBD06499-01-9

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advance directive expressly authorizing participation in research in specific risk/benefit categories.

14. "Assent" means affirmative agreement to participate in research. Mere failure to object does not constitute assent.

15. "Adult" means (a) a person over the age of eighteen years and (b) a person under the age of eighteen years who is (i) in a psychiatric facility on voluntary status on his or her own application, (ii) married or (iii) the parent of a child.

16. "Child" means a person under the age of eighteen who is not an adult as defined herein.

§ 2. Section 2442 of the public health law, as added by chapter 450 of the laws of 1975, is amended to read as follows:

§ 2442. Informed consent. 1. No human research may be conducted in this state in the absence of the voluntary informed consent subscribed to in writing by the human subject. If the human subject be a minor, such consent shall be subscribed to in writing by the minor's parent or legal guardian. If the human subject be otherwise legally unable to render consent, such consent shall be subscribed to in writing by such other person as may be legally empowered to act on behalf of the human subject. No such voluntary informed consent shall include any language through which the human subject waives, or appears to waive, any of his or her legal rights, including any release of any individual, institution or agency, or any agents thereof, from liability for negligence.

2. Any adult person who is determined to lack capacity to provide voluntary informed consent to human research shall be informed of the following if it is proposed to nevertheless use such person as a human subject: (a) that he or she has been found to lack capacity to make a decision regarding the research; (b) of the right to object to any human research he or she may be placed in; (c) of the right to appeal a finding of an incapacity to make a decision; (d) of the availability of legal counsel to assist in appealing a finding of such incapacity; (e) whether the proposed human research is possibly therapeutic or non-therapeutic; (f) the information described in subdivision five of section twenty-four hundred forty-one of this article; (g) the identity of the person who is proposed to act as a surrogate decision maker; and (h) the availability of legal counsel to challenge the identity of the surrogate decision maker.

§ 3. Section 2444 of the public health law, as added by chapter 450 of the laws of 1975, is amended to read as follows:

§ 2444. Human research review committees. 1. Each public or private institution or agency which conducts, or which proposes to conduct or authorize, human research, shall establish a human research review committee. Such committee shall be composed of not less than five persons, approved by the commissioner, who have such varied backgrounds as to assure the competent, complete and professional review of human research activities conducted or proposed to be conducted or authorized by the institution or agency. No member of a committee shall be involved in either the initial or continuing review of an activity in which he or she has a conflicting interest, except to provide information required by the committee. No committee shall consist entirely of persons who are officers, employees, or agents of, or who are otherwise associated with the institution or agency, apart from their membership on the committee, and no committee shall consist entirely of members of a single professional group. When the human research review committee reviews human research involving subjects with mental disorders that may affect decision making capacity, fifteen percent of the committee members, but no

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less than one member, must be a person with such a disorder or a family member of such person, or a representative of an advocacy organization concerned with the welfare of such persons. When the human research review committee reviews human research in which race, ethnicity or sex is proposed to be a factor affecting either inclusion or exclusion from human research, at least fifteen percent of the committee members, but no less than one, must be a member of the race, ethnicity or sex which is proposed to be included or excluded.

2. The human research review committee in each institution or agency shall require that institution or agency to promulgate a statement of principle and policy in regard to the rights and welfare of human subjects in the conduct of human research, and the committee and the commissioner shall approve that statement prior to its taking effect. The committee shall review each proposed human research project to determine (1) its necessity; (2) that the rights and welfare of the human subjects involved are adequately protected, (3) that the risks to the human subjects are outweighed by the potential benefits to them or by the importance of the knowledge to be gained; (4) that the voluntary informed consent is to be obtained by methods that are adequate and appropriate, and (5) that the persons proposed to conduct the particular medical research are appropriately competent and qualified. The committee shall periodically examine each existing human research project with regard to the proper application of the approved principles and policies which the institution or agency has promulgated. The committee shall report any violation to the commissioner. In addition to the voluntary informed consent of the proposed human subject as required by section twenty-four hundred forty-two of this [chapter] article, the consent of the committee and the commissioner shall be required with relation to the conduct of human research involving minors, [incompetent persons, mentally disabled persons] subjects with mental disorders that may affect decision making capacity and prisoners. All documents related to requests seeking the consent of the commissioner to conduct human research on minors, subjects with mental disorders that may affect decision making capacity, and prisoners, and the commissioner's ruling on such requests, shall be made available to the public upon reasonable request, provided that the commissioner may redact proprietary information and trade secrets. The nature of the risks and the nature of the procedures which are proposed to be conducted shall not be considered to be proprietary information or a trade secret.

3. Each person engaged in the conduct of human research or proposing to conduct human research shall affiliate himself or herself with an institution or agency having a human research review committee, and such human research as he or she conducts or proposes to conduct shall be subject to review by such committee in the manner set forth in this section.

4. No institution or agency shall retaliate against any member of its human research review committee for any action taken by the committee member in connection with his or her work on the committee which may or may not have had adverse effects on the research entity and any of its protocols. Any such aggrieved person may commence an action pursuant to the provisions of this article as if such aggrieved person were a human subject for the purposes of commencing such an action.

§ 4. Section 2445 of the public health law, as added by chapter 450 of the laws of 1975, is amended to read as follows:

§ 2445. Applicability. The provisions of this article shall [not] apply to the conduct of human research [which is subject to, and which

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is in compliance with, policies and regulations promulgated by any agency of the federal government for the protection of human subjects] conducted within the state of New York.

§ 5. The public health law is amended by adding six new sections 2447, 2448, 2449, 2450, 2451 and 2452 to read as follows:

§ 2447. Exclusion or inclusion of subjects to participate in human research based on race, ethnicity or sex. 1. When race, ethnicity or sex is proposed to be a factor affecting either inclusion or exclusion from human research, the entity proposing such research protocol shall be provided to the commissioner, with specificity, the criteria and the reasons why it is necessary to include or exclude members of a particular race, ethnic or sexual population, which shall include the goals of such research.

2. No such human research shall be conducted unless it is demonstrated that such research is necessary and that such research is the only manner by which the sought after information may be obtained. The approval of the commissioner shall only be granted upon the submission of such proof. All requests presented to the commissioner seeking such approval shall be published in the state register sixty days prior to the commissioner making a decision about such request.

3. This section will not apply to any human research which attempts to enroll subjects based on race, ethnicity or sex when such enrollment is an attempt to produce the numerical representation of these races, ethnicities or sexes in the general population of this state in particular or the United States in general.

§ 2448. Collection of data. On the first business day of March, on an annual basis, all entities conducting human research shall file with the commissioner the following information relative to all human research conducted in this state in the immediately preceding calendar year:

1. an abstract of each human research protocol which shall include a description of the hypothesis of the research, the various research procedures utilized and the risks and benefits which were presented by such research procedures to the human research subjects exposed thereto;

2. the number of subjects which were involved in each human research protocol;

3. an itemization of the number of subjects involved in each human research protocol by race, ethnicity, age, sex, capacity to consent and mental disorder and a statement of how such consent was obtained when such mental disorder is extant which shall be supported by a copy of the relevant consent form;

4. a statement as to whether the human research review committee consider such human research to be non-therapeutic or possibly therapeutic;

5. a statement as to whether the human research review committee considered such human research to present minimal risk or greater than minimal risk;

6. a description of the type of diseases, illnesses, symptoms and conditions which were studied in each such research protocol; and

7. a report of any unusual incidents or negative impacts, if any, suffered by the human subjects as a result of such research.

Failure to file this information on the required date, shall result in the immediate discontinuance of all human research for which such information was not provided, in a manner that safeguards the well being of the subjects. Furthermore, the commissioner shall halt further consideration of any new requests pending before him or her until such time as the research entity is in compliance.

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All such data collected shall be made available to the public upon reasonable request.