All elements under HBRA Section 12(1) (except for 1e and 1j), must be present in an ICF to make it "Appropriate Consent". This means that elements (e.g. regarding Incidental Findings) which are often deleted by PIs, must beincluded in your ICF. Even for questionnaire studies that fall under the scope of HBRA, there must be a statement on available compensation (if any) in the event of injury.
To help guide PIs, we have come up with Checklist A with all required elements for investigators to use. Please submit an amendment request if your ICF needs updating to comply with HBRA. Our ICF v5.5 onwards is compliant with these requirements.
For HBR studies, the following information should be provided to the research subject prior to taking appropriate consent:
- the investigational nature of the biomedical research;
- the purpose of the biomedical research;
- the reasonably foreseeable risks, discomforts or inconveniences arising from this biomedical research;
- the benefits which the research subject may reasonably expect from the biomedical research;
- where applicable, whether there are any alternative procedures or treatments available to the research subject, and the potential benefits and risks of such alternatives;
- any compensation and treatment available to the research subject in the event of injury arising from participation in the research;
- any anticipated expenses the research subject is likely to incur as a consequence of participating in the biomedical research;
- the extent to which information identifying the research subject will be kept confidential;
- whether individually-identifiable information obtained from the research subject will be used for future biomedical research;
- where applicable, whether biological material taken from the research subject will be destroyed, discarded or stored for future biomedical research;
- whether the participation of the research subject involves information in individually‑identifiable form;
- the circumstances, if any, under which, the research subject will be contacted for further consent, including but not limited to changes in the proposed research, serious adverse events that would lead to a change in the proposed research, the development of capacity by minors to make decisions and any other circumstances which could be specific to a particular research proposal;
- whether the research subject would wish to be re‑identified in the case of an incidental finding if the proposed biomedical research expressly provides for such re‑identification;
- the research subject's right to withdraw his or her consent and the limitations of such withdrawal as specified in that section;
- the person or persons to contact to obtain further information on the biomedical research and to provide feedback in relation to the biomedical research, respectively;
- such other information as the institutional review board may require;
- such other information as may be prescribed.
[Update: 17 May 2019]
MOH has released a Guidance on Appropriate Consent on requirements for Appropriate Consent. Please note that MOH will be starting enforcement actions on researchers who are recruiting research subjects for HBR studies without full Appropriate Consent.