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St. Cloud State University

St. Cloud State University

The Informed Consent Process

The Informed Consent Process

What is the Informed Consent Process?

The informed consent process begins when you first approach potential subjects and continues throughout your research. Typically, it involves:
  • presenting information that enables an individual to knowledgeably and voluntarily decide whether or not to participate as a research subject
  • documenting consent with a written form signed by the subject
  • responding to the subject’s questions/concerns during the research and communicating any new findings that may affect the subject’s willingness to continue participating.

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What Information Must Be Provided to Subjects? The Informed Consent Checklist

    The following information must be explained to each potential subject:
    1. ___ purposes of the research and expected duration of the subject's participation
    2. ___ procedures to be followed and whether or not they are considered experimental
    3. ___ any reasonably forseeable risks or discomforts to the subject
    4. ___ any reasonably expected benefits to the subject or others as a result of the reasearch
    5. ___ appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
    6. ___ the extent, if any, to which confidentiality of records identifying the subject will be maintained
    7. ___ terms and nature of compensation, if any (monetary or otherwise)
    8. ___ medical treatments available, if any, should injury occur as well as how to obtain further information about the treatments and whom to contact in the event of a research-related injury
    9. ___ where/how overall and/or individual research results will be made available
    10. ___ suggested additional resources related to the research topic, if any, that may be of interest to the subject
    11. ___ whom to contact for answers to pertinent questions about the research and subjects' rights and how to contact them (typically, you as the researcher; a student must also include contact information for an advisor)
    12. ___ participation is voluntary, refusing to participate or discontinuing participation will involve no penalty or loss of benefits to which the subject is otherwise entitled

    When appropriate the following should be explained as well:

    1. ___ a particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable
    2. ___ circumstances under which the subject's participation may be terminated by the investigator
    3. ___ any additional costs to the subject that may result from participation in the research
    4. ___ the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
    5. ___ significant new findings developed during the course of the research which may relate to the subjects willingness to continue participation will be provided to the subject
    6. ___ the approximate number of subjects involved in the study


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How Do I Document Informed Consent?

You must document an individual's decision to participate in your research using a written consent form. The consent form may be either of the following:

FULL FORM
A full form includes all of the required elements of informed consent as outlined in the checklist above. Even though you may review some or all of the information orally, you must give the potential subject an opportunity to read the form before signing it. Leave a copy of the form with the subject for future reference.

SHORT FORM
A short form states that the required elements of informed consent, as outline in the checklist above, have been presented orally to the subject. A witness must be present if you use the short form. The subject and the witness sign the short form; you and the witness sign a copy of the oral summary. Leave a copy of the short form and the oral summary with the subject for future reference.

All consent documents must be approved by the Institutional Review Board

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How Do I Help Potential Subjects Understand My Research? Tips for Conveying Information

Language
When communicating with your subjects orally or in writing, present information clearly and concisely. Use simple, everyday language and avoid jargon. If it is necessary to use scientific medical, or legal terms, define them.

Appearance- The Consent Document
Use fonts, font sizes, and margins that make the consent document(s) easy to read. Break up large sections of text with headings. It is more important for a document to look clean and attractive than it is for it to be confined to one page.

Audience
When more than one group of subjects is involved in your research, tailor consent information/documents to each group. For example, observing adult classrooms would require informed consent from both instructors and students: you may want to develop seperate consent forms for each. In addition, consent information/documents should reflect the capacities of those invited to participate. For example, an assent document for 8 year-olds should be much simpler than a consent document for adults.

Overall Effectiveness
Ask others who are unfamiliar with your research to review your consent information/documents and provide feedback. Is it understandable? Should any information be added or removed? Is it easy to read?

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How Does the Process Differ for Anonymous Surveys/Questionnaires?

When using an anonymous survey or questionnaire to collect data, you may fulfill the informed consent requirement by providing subjects with a cover page or letter that explains the flollowing items:

  1. ___ purposes of research and expected duration of the subject's participation
  2. ___ whom to contact for answers to questions about the research and how to contact them (typically, you as researcher; a student must also include contact information for an advisor)
  3. ___ where/how overall research results will be made available
  4. ___ suggested additional resources related to the research topic, if any, that may be of interest to the subject
  5. ___ anonymity of the results: the subject cannot be identified
  6. ___ implied consent: "returning the questionnaire indicates your voluntary consent to participate"
  7. ___ paricipation is voluntary, refusing to participate or discontinuing participation will involve no penalty or loss of benefits to which the subject is otherwise entitled

Feel free to use language from the Informed Consent Template. Modify it as necessary to fit your research activity. Implied Consent documents for anonymous surveys or questionnaires should not include a signature line: consent is implied.

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How Does the Process Differ for Subjects Who are Minors/Children?

When your research involves individuals under the age of eighteen, you must obtain and document the consent of parents or guardians. usually, consent from one parent/guardian is sufficient for research that involves minimal risk or may directly benefit the child/minor. A parental/guardian consent document includes all of the required elements of informed consent as outline in the checklist.

In addition to the consent of parents or guardians, you must obtain and document the assent of children/minorsd who are capable of deciding whether or not to participate in your research (typically, age 8-17). The amount and complexity of information you present will vary depending upon the age and maturity of your potential subjects. A simple description might be appropriate for a 9 year-old; whereas, a full explanation of the required elements of informed consent would probably be appropriate for a 17 year-old.

A single project could require:

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