Schedule 5 · Waiver of requirements for appropriateconsent by institutional review board

FIFTH SCHEDULESections 13(1), 17(1)(f) and 62(1)Waiver of requirements for appropriateconsent 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 research cannot reasonably be carried out without the use of the human biological material or health information in an individually‑identifiable form;

the process of obtaining consent from the person, to which the individually‑identifiable human biological material or health information relates, will involve a disproportionate amount of effort and resources relative to the research requirements;

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

the human biomedical research or health information research would reasonably be considered to contribute to the greater public good.

the individually-identifiable health information was obtained or compiled before 1 November 2017;

the research cannot reasonably be carried out without the use of the health information in an individually‑identifiable form;

the use of the individually‑identifiable health information involves no more than minimal risk to the research subject;

the waiver concerned will not otherwise adversely affect the research subject’s rights and welfare; and

the process of obtaining consent from the person, to which the individually‑identifiable health information relates, will involve a disproportionate amount of effort and resources relative to the research requirements.

the individually‑identifiable human biological material was obtained or compiled before 1 November 2017;

the research cannot reasonably be carried out without the use of the human biological material in an individually‑identifiable form;

the use of the individually‑identifiable human biological material involves no more than minimal risk to the research subject;

the waiver concerned will not otherwise adversely affect the research subject’s rights and welfare; and

reasonable effort has been made to re‑contact the person to which the individually‑identifiable human biological material relates for the purpose of obtaining his or her consent.Part 3WAIVER OF REQUIREMENT FOR APPROPRIATE CONSENT FOR emergency RESEARCH6. 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;

there is no professionally accepted standard of treatment or the available treatments are unproven or are unsatisfactory;

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;

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

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; and

provision is made for any person as follows, or combination of such persons, to certify to the best of that person’s or combination of persons’ knowledge that sub‑paragraphs (a) and (e) have been complied with:

a medical practitioner who is registered under the Medical Registration Act 1997 as a specialist in the specialty relating to the research and who is not involved in the research as a researcher or supervisor;

a person approved by the Director‑General by name, or holding the office or designation or falling within the description approved by the Director‑General.[Act 11 of 2023 wef 01/05/2023]7. In paragraph 6, “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.[S 623/2017; S 701/2019]