Research

Obtaining Consent/Permission/Assent

Potential research participants must be accurately told what a project involves, then given complete freedom to decide whether to join the study. 

Consent as a Process

Consent should be thought of as an ongoing process. The process may be brief or lengthy depending on the nature of the project, the population being consented, and the circumstances under which consenting takes place.

The informed consent process must be planned with the following questions in mind:

  • Do potential subjects have enough time and attention to give to making the decision?
  • Is the situation free of pressure (real or perceived) 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?

Required Elements in Consent Scripts

Researchers must provide the IRB with a written form or oral script that clearly communicates the necessary information to potential participants. See the Informed Consent Examples page for scripts/forms that could be adapted for use in various common types of research.

The default approach is to have participants document their consent with a written signature. Alternatively, researchers can ask for a "waiver" that makes physical signatures unnecessary (e.g. for an online survey). Researchers can also ask to alter or waive other aspects of the consent process. For information on when this is allowed, see the web page on Waiving Consent or Documentation of Consent.

Without a waiver, all informed consent forms/scripts must include the following elements (though not necessarily using these precise words):

  1. 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;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. 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);
  6. 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;
  7. 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;
  8. An explanation of any payments or compensation to subjects as a result of participation (visit MTU’s specific compensation procedures in this regard).
  9. 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.

Consent Involving Children

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, using language that the subject can understand as clearly as possible. For more general information on research involving children, visit Research Involving Children.

Ethnography / Participant Observation

Consent for participant observation projects has to be especially flexible, and it often involves multiple elements. The details of a specific project will determine whether written or oral documents/scripts are appropriate, and whether there is a need for translations or interpreters. Some elements that are commonly involved are:

  • A basic document that covers the required consent information, for use as a handout or oral script when anyone asks for details about your study.
  • A similar script for presenting at any necessary community/group introduction sessions.
  • A script or form to use in recorded interviews with key informants.
  • A short information script to use orally when situations suddenly require some kind of disclosure and agreement to be observed in private settings.

The last of these elements highlights the fact that participant observers must pay close attention to whether observed activities are considered public or private by the people involved. When the boundary is crossed from public to private, some kind of consent process must begin if you want to continue making observations.