Singapore legislation
Schedule 5
Schedule 5
Waiver of requirements for appropriate consent by institutional review board
FIFTH SCHEDULESections 13(1), 17(1)(f) and 62(1)Waiver of requirements for appropriate consent by institutional review boardPart 1waiver of requIRements for appropriate consent TO BE IN WRITING1. Where the institutional review board is satisfied that the human biomedical research or use of the human tissue, as the case may be, involves no more than minimal risk to the research subject or donor and involves no procedures for which written consent is ordinarily required outside of a research context (for therapeutic or diagnostic purposes).
2. Where the institutional review board is satisfied that the only record linking the research subject and the human biomedical research or use of the human tissue, as the case may be, is or will be the consent form and the principal risk to the research subject or donor is the potential harm resulting from the unauthorised disclosure of confidential information such as the research subject’s identity and the fact of the subject’s participation in the research.Part 2WAIVER OF REQUIREMENT FOR APPROPRIATE CONSENT FOR HUMAN BIOMEDICAL RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIAL OR HEALTH INFORMATION3. Where the institutional review board is satisfied that —
the individually-identifiable human biological material or health information research, as the case may be, may not practicably be carried out unless there is a waiver;
the use of the individually-identifiable human biological material or health information, as the case may be, involves no more than minimal risk to the research subject or donor;
the waiver concerned will not otherwise adversely affect the rights and welfare of the research subject or donor; and (d)the human biomedical research or health information research would reasonably be considered to contribute to the greater public good. Part 3WAIVER OF REQUIREMENT FOR APPROPRIATE CONSENT FOR emergency RESEARCH 4. Where the institutional review board is satisfied that the human biomedical research is emergency research and where —
the research subjects are in a life-threatening situation; (b)there is no professionally accepted standard of treatment or the available treatments are unproven;
the collection of valid scientific evidence is necessary to determine the safety and effectiveness of a particular intervention or treatment;
participation in the proposed research holds out the prospect of direct benefit to the research subjects;
obtaining appropriate consent is not feasible because —
the subjects will not have capacity within the time available to give their appropriate consent as a result of their medical condition or situation; and
no person who is authorised to give appropriate consent on behalf of the research subject under section 6 is available;
the human biomedical research may not practicably be carried out unless there is a waiver; (g)provision is made for one of the following, whichever occurs first:
the research subject is to be informed as soon as is practicable after he or she regains capacity of his or her participation in the research and given an opportunity to withdraw from further participation in the research; or (ii)the person who is authorised to give appropriate consent on behalf of the research subject under section 6 to be informed as soon as is practicable of the subject’s participation in the research and to be given an opportunity to request that the subject be withdrawn from further participation in the research; or
provision is made for a medical practitioner who is registered under the Medical Registration Act (Cap. 174) as a specialist in the specialty relating to the research and who is not involved in the research as a researcher or supervisor to certify, prior to the enrolment of the research subject to the best of the specialist’s knowledge that sub‑paragraphs (a) to (e) have been complied with.
5. In paragraph 4, “emergency research” means human biomedical research where life‑threatening emergency situations may arise such that appropriate consent may not be obtained before the research subject is subjected to any intervention or after any individually‑identifiable biological material is obtained from his or her body, or any of his or her individually‑identifiable health information is used.