April 2013
Informed Consent Document and Process
Overview of Informed Consent
Informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a
particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to
participate. Informed consent is documented by means of a written, signed and dated informed consent form. The
process is necessary to ensure that subjects are fully informed before deciding to volunteer as research subjects.
Informed Consent Document
If the study involves many non-English speaking subjects, the Principal Investigator should include and project the
costs for translations of the DSRB approved consent forms into the study grants and contract. It is the responsibility of
the Principal Investigator to ensure that there is provision of adequate resources to obtain proper informed consent
from the subjects. In the event where the informed consent form has not been translated and is not available in the
language understandable to the subject, and as an alternative for Investigator-initiated studies (for all types of
research), oral presentation of informed consent information may be used and documented using:
i.
the DSRB-approved English language informed consent form serving as the written summary of the information
to be orally translated and presented to the subject and;
ii.
a Short Consent Form (SCF) stating that the elements of informed consent have been presented orally to the
subject or the subject’s legally acceptable representative.
When developing the Short Consent Form (SCF) for submission to DSRB, the Principal Investigator needs to
ensure that the following are met:
• Each local-language (Malay, Mandarin and Tamil) of the SCF (as applicable) should be appended to a separate
copy of the DSRB-approved English language Informed Consent Form (ICF)
• A document footer (indicating document version number and version date) and page number should be provided to
act as a reference linking the two documents
After receiving approval from DSRB on the use of the ICF with SCF, the Principal Investigator and/ or
designated study staff delegated to obtain consent should ensure that:
• Oral presentation and the presentation of the SCF should be in a language understandable to the subject.
• An *impartial witness who is fluent in both English and the language understandable to the subject is required (if
applicable) to be present during the informed consent process.
• The study team member who is obtaining consent should not be the witness.
• The subject/subject’s legally accepted representative (LAR), the study team member who is obtaining consent and
the impartial witness should sign on both the DSRB-approved English language ICF and the SCF in a language
understandable to the subject.
• The subject/subject’s LAR should be provided with a copy of the complete set of the DSRB-approved English
language ICF and the SCF.
• The Principal Investigator and/ or study team member who conducted the informed consent discussion must sign
and date the consent form and record the date of informed consent as well as the fact that a copy was given to the
subject in the subject’s medical record.
*A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who
attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and
who reads the informed consent form and any other written information supplied to the subject.
Informed consent is not a one time single event prior to enrolling research subjects, but must be a continuous ongoing
process. Investigators must inform subjects of any important new information that may affect their willingness to
continue participation and the DSRB must approve the method of notification prior to implementation (i.e. Information
letter, addendum to previously signed consent form to be signed by subject/subject’s LAR, revised consent form to be
signed).
For other Frequently Asked Question on ICF, you may also refer to HSA’s website at
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials/faqs.html#(H)
Article Contributed By:
Veron Lu, Research Executive
National Skin Centre
Edited By: NHG-RDO
References:
•Singapore Good Clinical Practice Guidelines SGGCP 4.8
•NHG Proper Conduct of Research SOP 501-C01: Informed Consent Form and Process
http://www.research.nhg.com.sg/wps/wcm/connect/romp/nhgromp/resources/research+sops
Proudly brought to you by: Clinical Research
Coordinator Society (CRCS) [email protected]