Potential research subjects must be accurately informed of what a project involves, and given the opportunity to decide of their own free will whether or not to participate.
This process may be brief or lengthy depending on the components of the project, the population being consented, and the circumstances under which the consent process takes place.
Informed consent procedures must be planned with the following questions in mind:
- Are potential subjects in a situation where they have enough time and attention to give to making the decision?
- Is the situation free of pressure (or perceived pressure) from other parties to participate?
- Does the situation ensure enough privacy and confidentiality for studies where people may not want their participation to be known?
- Is consent needed from individuals other than the potential subjects themselves, such as required guardians or legally appointed representatives (e.g. for children or cognitively impaired people)?
- What language and terminology will be most effective at helping people understand the risks and requirements of the study?
- How will people be given an adequate opportunity to ask any questions they might have, and have them answered?
- What kind of training might the research team members obtaining consent require?
It is important for an informed consent process to have a good form or script. While the default type of form is designed to be read and signed by the subject, some projects obtain "waivers" that make signatures unnecessary (for example on an online survey), or allow the script to be verbally presented to the subject. For information on requesting different kinds of waivers, visit Waiving Consent or Documentation of Consent.
All informed consent forms/scripts should include the following:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed and identification of any procedures which are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained (including audio and video recordings, if relevant);
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled;
- An explanation of any payments or compensation to subjects as a result of participation (visit MTU’s specific compensation procedures in this regard).
If the study involves the collection of identifiable private information or identifiable biospecimens, the consent form must include one of the following:
A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility;
or
A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
Additional elements may be needed for research funded by some government agencies, for clinical studies or trials, for studies that collect biospecimens, for studies posing more than minimal risks, and as otherwise required by the IRB. See section 9.7.2 of the MTU HRPP Policies and Procedures document for details.
Researchers may want to use HRPP's downloadable consent form template. The template is not mandatory - any form or script that adequately covers the necessary criteria is acceptable - but it may provide a useful guide. The template is of the default type, i.e. for reading and signing, so its language will need to be adapted appropriately for verbal or signature-less procedures. For some projects it will also have to be translated into languages other than English.
When individuals are providing consent for others (e.g. children), the wording of the form must be changed accordingly. For example, phrases like "I understand that I will be asked to.." must be changed to "I understand that my child will be asked to..." In addition to gaining a parent or representative's permission, a second “assent” form/script must be used to help the subject themselves decide if they want to participate. The assent form should be written to be easily understood by the target population, use language that the subject can understand as clearly as possible. A downloadable example of an sample assent script is available for guidance. For more general information on research involving children, visit Research Involving Children.