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Instructions for Obtaining Consent

In general, researchers should insure that their research participants are voluntary participants. Consent refers to a person's freely given choice to participate in a research project based on full knowledge and understanding of the project and its implications for the participants’ welfare. In some cases this requires the use of written consent forms signed by the research participants. In other cases, it is sufficient to inform the participants of the nature of the research and that their participation is voluntary. In these cases the completion of the survey is an indication of consent.

Research Not Requiring Written Consent

Research involving no more than minimal risk of harm to human participants still requires the participants' consent, but may not require that participants sign a written consent form. Anonymous surveys and interviews that present minimal risk, for example, may not require written consent. Subjects who do not consent simply do not fill out the survey. Nonetheless, there are several requirements to insure that the participant is voluntary. Surveys and interviews must be conducted in a setting and manner that is non-coercive. The researcher should provide the participants with the following information (surveys should attach this information as a cover sheet of the survey—see  sample):
 

  1. A statement of the nature, purposes, and expected duration of the research (the participants must know that they are involved in research).
  2. The names of those who are conducting the survey and any sponsoring organizations.
  3. The uses that will be made of the research information.
  4. A statement that participation is voluntary and that the participant may refuse to participate or discontinue participation at any time without penalty.
  5. An explanation of whether the survey is anonymous or merely confidential. When participants can be identified from demographic data the survey is not anonymous even if the participant's identity is kept confidential. In this case a statement must be included describing how confidentiality of records will be maintained and who will have access to such records.
  6. A statement of implied consent, such as “Your willingness to return the completed questionnaire indicates your consent to participate in this study.”
  7. An explanation of whom to contact regarding concerns about the research (this should include the telephone number or e-mail address of the person conducting the research)

Research Requiring Informed Consent Forms

Research that imposes more than a minimal risk on participants typically requires written consent signed by the participant. These forms should be retained by the researcher, and copies should be provided to each participant signing the form. The participant should be given an adequate opportunity to read the consent form before signing it. Informed consent requires that the participant (or their representative) be given explanations of the following basic elements:

  1. A statement of the nature, purposes, and expected duration of the research (the participants must know that they are involved in research).
  2. A description of the procedures to be followed, including reference to any uses of audio or visual recordings, and identification of any procedures used that are experimental.
  3. A description of any reasonably foreseeable discomforts or risks to the participants, as well as a description of any benefits to the participants (including any compensation if provided).
  4. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained and the individuals who may have access to such records.
  5. An explanation as to whether any compensation or medical treatments are available if injury occurs, and, if so, what they consist of, where they may be obtained, and where additional information may be obtained.
  6. A statement that participation is voluntary and that the participant may refuse to participate or discontinue participation at any time without penalty.
  7. The uses that will be made of the research information.
  8. An explanation of whom to contact regarding concerns about the research and research participants' rights (this should include the telephone number or e-mail address of the person conducting the research).

Documentation of Consent

Principal investigators shall be responsible for ensuring that consent is documented by the use of the consent procedures approved by the IRB. With respect to research that presents minimal risk, such as questionnaires that are distributed and returned anonymously, the return of the questionnaire may be sufficient documentation of participant implied consent. Research that imposes more than a minimal risk on participants typically requires written consent signed by the participant, or the participant’s legally authorized representative. Documentation of informed consent will usually involve the signature of the participant on a form, which includes the basic elements of informed consent and the date. The description of the research procedures may be presented on a separate sheet. Each participant should be provided a copy of the consent form and information sheet.

When the participants include individuals who are not legally or physically capable of giving documented informed consent, because of age, mental incapacity, or inability to communicate, then consent should be obtained from the participant’s legally authorized representative (i.e., parents or legal guardians of children, or the guardian of a person adjudged incompetent, or any person authorized in writing by the participant). Careful consideration must be given to whether third parties have both the legal authority and sufficient interest in and concern for the individuals to provide consent.

When research participants are minors, in addition to obtaining written consent from parents or legal guardians, the participants also should be asked for their oral consent (assent) to participate in the research project, if they are capable of providing assent. The child should be given an explanation, at a level appropriate to the child’s age, maturity and condition, of the procedures to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research.  A written form should be used to document assent for children who are 12 years of age and over.

In some research situations, full disclosure of the aims of the study before the fact may invalidate results. In these cases, the investigator should describe procedures that the participant will be asked to participate in and state the aim of the study in as clear and as accurate a manner as possible so as to maintain the integrity of the research. In preparing the proposal for Board review, any deception in the research should be clearly identified. The rationale for deception and plans for after-the-fact debriefing of participants should be provided to the review Board.

Investigators are responsible for retaining the research proposal submitted to the IRB and consent documents signed by human research participants for at least seven years in a secure location.

Contact Us

The Human Participants Review Board is always available to answer any questions investigators may have. To contact the IRB please use the following information:

Edgewood College IRB
1000 Edgewood College Drive
Madison, WI  53711
lambert@edgewood.edu; aholland@edgewood.edu