Procedure for Obtaining Informed Consent for Research on Humans
Researchers must provide to prospective subjects, or to authorized third parties, full and frank disclosure of all information relevant to free and informed consent. Throughout the free and informed consent process, the researcher must ensure that prospective participants are given adequate opportunities to discuss and contemplate their participation. Subject to the Exception stated in the Free and Informed Consent section (9.3) of the Ethics of Research Involving Human Participants policy, at the commencement of the free and informed consent process, researchers or their qualified designated representatives must provide prospective participants, as a minimum, with the following:
- information that the individual is being invited to participate in a research project;
- comprehensible statement of the research purpose, the identity of the researcher, the expected duration and nature of participation, and a description of research procedures;
- a comprehensible description of reasonably foreseeable harms and benefits that may arise from research participation, as well as the likely consequences of non-action, particularly in research related to treatment, or where invasive methodologies are involved, or where there is a potential for physical or psychological harm;
- an assurance that prospective subjects are free not to participate, have the right to withdraw at any time without prejudice to pre-existing entitlements, and must be given continuing and meaningful opportunities for deciding whether or not to continue to participate;
- the possibility of commercialization of research findings, and the presence of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors;
- the name and contact information for a person who may be contacted in the case of concerns, complaints, or consequences.
Additional information may be necessary in order to obtain fully informed consent, including but not necessarily limited to: provision of new information relevant to the decision to continue or withdraw from participation, identity of those who will have access to data, how privacy will be protected, the circumstances under which the researcher may terminate participation, alternative treatments for participants in clinical trials, how the results of the research will be disseminated to participants and through publication.