Research Consent Form (Singapore)

A Research Consent Form in Singapore records the consent or release given and the scope of what the party agrees to.

The Human Biomedical Research Act 2015, administered by the Director of Medical Services under the MOH, establishes mandatory requirements for obtaining informed consent before conducting human biomedical research in Singapore. Section 14 of the HBRA requires that consent be given voluntarily by a person who has been informed of the nature and likely effects of the research, and who has the mental capacity to give consent. The HBRA applies to all human biomedical research conducted in Singapore, including research involving human tissue, genomic data, and health information.

For clinical trials of therapeutic products (drugs, biologics, and medical devices), the Health Products Act (Cap. 122D) and the Health Products (Clinical Trials) Regulations 2016 impose additional consent requirements aligned with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. The Health Sciences Authority (HSA), which regulates clinical trials in Singapore, requires that informed consent documents for clinical trials include specific elements prescribed by ICH-GCP E6(R2), including a description of the study drug, the randomisation procedure, the participant's right to withdraw, and the availability of compensation for trial-related injuries.

The PDPA 2012 applies to all research that involves the collection, use, or disclosure of personal data of research participants. Section 13 of the PDPA requires organisations to obtain consent for the collection of personal data and to notify individuals of the purposes for which the data will be collected, used, or disclosed. The Personal Data Protection Commission (PDPC) has issued Advisory Guidelines on the PDPA for the healthcare sector, clarifying how PDPA obligations interact with research consent requirements.

Singapore's research ethics infrastructure includes the National Healthcare Group (NHG) Domain Specific Review Board (DSRB), the SingHealth Centralised Institutional Review Board (CIRB), and university-based IRBs at the National University of Singapore (NUS) and Nanyang Technological University (NTU). Each IRB reviews research consent forms as part of the ethical approval process and requires that consent forms meet both statutory requirements and institutional standards for clarity, completeness, and participant protection.

Singapore's Bioethics Advisory Committee (BAC), established by the Cabinet in 2000, issues ethical guidelines that supplement the statutory framework. The BAC's Ethics Guidelines for Human Biomedical Research (2015, revised 2021) address emerging research areas including stem cell research, human genetics, and artificial intelligence in clinical decision-making. Research institutions in Singapore must demonstrate compliance with both statutory requirements and BAC guidelines when submitting consent forms for IRB review. The Agency for Science, Technology and Research (A*STAR), which funds and oversees government-funded research institutes including the Genome Institute of Singapore and the Bioinformatics Institute, requires all funded research to comply with the BAC guidelines and the HBRA consent requirements.

A Research Consent Form is needed whenever a researcher, research institution, or sponsor conducts a study involving human participants in Singapore, regardless of whether the research is biomedical, social, behavioural, or educational in nature.

All human biomedical research conducted in Singapore requires informed consent under Section 14 of the Human Biomedical Research Act 2015 (HBRA). Biomedical research includes any study involving the collection or use of human tissue, genomic data, health information, or physiological measurements. Researchers must present the consent form to the participant before any study procedures begin, and the participant must sign the form voluntarily without coercion, undue influence, or inducement.

Clinical trials regulated by the Health Sciences Authority (HSA) under the Health Products (Clinical Trials) Regulations 2016 require consent forms that comply with ICH-GCP E6(R2) standards. The principal investigator must personally explain the study to each participant, answer all questions, and obtain written consent before the participant undergoes any trial-related procedure, including screening assessments. The HSA conducts inspections of clinical trial sites and reviews consent documentation as part of its regulatory oversight.

Research involving the collection of personal data requires consent under Section 13 of the PDPA 2012. Researchers collecting survey responses, interview transcripts, photographs, video recordings, or any other data that identifies or could identify an individual must obtain PDPA-compliant consent specifying the purposes of data collection and the safeguards applied. The PDPC has clarified that research consent forms should state the specific research purpose — not merely a generic research purpose — for which personal data will be used.

Social science and behavioural research conducted at Singapore universities and research institutions requires IRB approval and informed consent, even where the research does not fall within the statutory scope of the HBRA. The NUS-IRB, NTU-IRB, and Singapore Management University (SMU) IRB each maintain consent form templates and require researchers to use approved consent language.

Research involving minors (persons under 21 years of age in Singapore, as defined by the Age of Majority Act, Cap. 7) requires consent from a parent or legal guardian, in addition to the minor's own assent where the minor is capable of understanding the research. Section 16 of the HBRA prescribes specific requirements for obtaining consent for research involving persons who lack capacity to consent, including the appointment of an appropriate consent-giver. A related Data Collection Consent Form may be needed where the research involves ongoing data collection beyond the initial study, and a Medical Consent Form applies where the research involves clinical interventions.

A Singapore Research Consent Form must contain the following elements to satisfy the Human Biomedical Research Act 2015 (HBRA), the PDPA 2012, ICH-GCP standards (where applicable), and IRB requirements.

Study identification must state the full title of the research study, the principal investigator's name and professional qualifications, the institutional affiliation (hospital, university, or research centre), the IRB reference number (NHG DSRB, SingHealth CIRB, NUS-IRB, or NTU-IRB as applicable), and the study sponsor's name and contact details. For clinical trials, the HSA Clinical Trial Certificate (CTC) number must be stated.

Purpose of the study must describe in plain language the research question, the objectives of the study, and the expected contribution to scientific or medical knowledge. The description should avoid technical jargon and be written at a reading level appropriate for the target participant population. MOH guidelines recommend that consent forms be written at a secondary school reading level.

Study procedures must describe what the participant will be asked to do, including the number and duration of study visits, the types of procedures (blood draws, surveys, interviews, imaging, physical examinations), and whether any procedures are experimental or differ from standard clinical care. For randomised controlled trials, the consent form must explain the randomisation process and the possibility of receiving a placebo.

Risks and discomforts must describe all reasonably foreseeable risks, side effects, and discomforts associated with participation. The description must distinguish between common and rare risks and between serious and minor risks. For clinical trials of therapeutic products regulated by the HSA, the consent form must describe known adverse effects of the study drug based on available pre-clinical and clinical data.

Benefits must describe any direct benefits the participant may receive (such as access to an experimental treatment) and the broader scientific or societal benefits of the research. The consent form must not overstate potential benefits or create therapeutic misconception — the mistaken belief that the primary purpose of the research is to benefit the individual participant rather than to generate scientific knowledge.

Confidentiality and data protection must describe how the participant's personal data and study data will be collected, stored, used, and disclosed, consistent with the PDPA 2012. The consent form must state the specific purposes for which personal data will be used (Section 18 of the PDPA), the safeguards applied to protect data security (Section 24 of the PDPA), and the participant's right to access and correct personal data (Section 21 of the PDPA). For research involving genomic data, the HBRA Section 22 requirements for coded and anonymised data must be addressed.

Voluntary participation and withdrawal must state clearly that participation is voluntary, that the participant may withdraw at any time without penalty or loss of benefits to which they are otherwise entitled, and that withdrawal will not affect the participant's relationship with the research institution or access to clinical care. The forms-legal.com Research Consent Form template incorporates all mandatory elements required by the HBRA, PDPA, and major Singapore IRBs, with guidance notes aligned with MOH and HSA regulatory requirements. A related Statutory Declaration may be needed where the research involves sworn statements, and an Affidavit may be required for court-ordered research disclosures.

Compensation and injury provisions must state whether the participant will receive any payment or reimbursement for participation, and describe the provisions for treatment and compensation in the event of a research-related injury. For clinical trials, the consent form must state whether the sponsor provides insurance or indemnity coverage, consistent with the HSA's requirements under the Health Products (Clinical Trials) Regulations 2016. Under Singapore law, the Human Biomedical Research Act 2015 and the PDPA 2012 govern the core requirements for this type of document.