Control of Clinical Trials Act, 1987

Participants in clinical trial.

9.—(1) A person shall not be a participant in a clinical trial unless a consent to such participation has been given in accordance with this section.

(2) Subject to subsection (7), a consent to participation in a clinical trial shall not be valid unless given in writing and signed by the person who is to be the participant in the trial.

(3) Any consent given for the purposes of this section shall not be valid unless—

(a) the person so consenting is capable of comprehending the nature, significance and scope of his consent, and

(b) it is obtained by or on behalf of the person conducting the clinical trial.

(4) The person conducting the clinical trial shall ensure that every person shall, before giving his consent in accordance with this section, be made aware of the following matters—

(a) the objectives of the trial,

(b) the manner in which the substance or preparation is to be administered,

(c) the risks and any discomfort involved in, and the possible side-effects of, the trial,

(d) whether or not a pharmacologically inactive substance or preparation is to be administered to some persons in respect of each of whom a consent has been given to being a participant in the trial in accordance with this section,

(e) such other matters (if any) as may be—

(i) prescribed by regulations made by the Minister under this Act, or

(ii) specified in the permission granted by the Minister under section 4 .

(5) Unless otherwise provided for by virtue of the permission granted by the Minister under section 4 or of any amendment to that permission agreed to by him under section 5 , a clinical trial shall not be conducted on any person within the period of 6 days after the day on which the provisions of section 9 (4) have been complied with in respect of such person.

(6) Any person who has given his consent in accordance with this section may withdraw it at any time and no contractual liability shall be incurred by such person from such withdrawal.

(7) Where it is proposed to conduct a clinical trial on any person suffering from an illness, the remedy for or alleviation of which constitutes an objective of the trial, the following provisions shall apply:

(a) where such a person is capable of comprehending the nature, significance and scope of a consent to be given for the purposes of this section but is physically unable to give such consent in accordance with subsection (2), his consent clearly given in any other manner shall be sufficient where it is so given, in the presence of two witnesses present at the same time, to a registered medical practitioner who is treating him for that illness and where the consent is expressed in writing and is attested by the signatures of both witnesses;

(b) where such a person is incapable of comprehending the nature, significance and scope of a consent to be given for the purposes of this section, that person may be a participant in a clinical trial only if a written and signed consent is given for such a participation by a person or persons, independent of the person who applied to undertake or is conducting the trial, who in the opinion of the ethics committee is or are competent to give a decision on such a participation:

Provided that a clinical trial to which this subsection relates may be conducted only if the substance or preparation under trial is to be administered for the purpose of saving the life of such a person, restoring his health, alleviating his condition or relieving his suffering.

(8) No person shall offer or cause to be offered to a person for becoming or being a participant in a clinical trial any inducement or reward (whether monetary or otherwise) unless provided for by the permission to undertake the clinical trial.