Preparing the Informed Consent

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Consent, Assent and Parental Consent

Consent Form

Obtaining the informed consent of a potential human subject for participation in any research (whether an experiment, survey, interview, or demonstration) is a federally mandated safeguard for protecting the rights and welfare of all individual subjects. Therefore, the IRB will very carefully review the method of obtaining and the content of informed consent listed below.

When consent forms require signatures of research subjects and/or their parents or legal guardians, a copy of the fully signed form must be given to the subject/parent/guardian and a copy must be retained by the researcher for a minimum of three years after completion of the project. The consent form should avoid jargon and should be presented in lay persons’ language, and appropriate to the “audience.”

There are times when the requirements of Informed Consent may be altered or waived – See below:

Waiver of Documentation of Consent (aka "Verbal" or "Online" consent)

Waiver of Documentation of Consent

Definition: Subjects consent to participate but do not sign a consent form.

Situation when it is used: In minimal risk research involving mailed or internet surveys, telephone interviews, or when sensitive information is collected and you do not want any paperwork that names the subject.

Waiver or Alteration of the requirements for Informed Consent

Waiver or Alteration of the Requirements for Informed Consent

Definition: The research is conducted without obtaining consent from the subject.

Situations when it is used: Medical chart reviews or analysis of existing data or in rare cases where secondary subjects may be involved and it would either be prohibitive or potentially dangerous to obtain consent.

Informed Consent Requirements
The following list provides guidelines for meeting the basic requirements of a well-designed consent document:

- Disclose that the study involves research
- Explain the purposes of the research
- Explain the expected duration of the participant’s participation
- Describe the procedures to be followed
- Identify any procedures that are experimental
- Describe any reasonably foreseeable risks or discomforts to the participant
- Describe any benefits to the participant or to others which may reasonably be expected from the research
- Disclose appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant
- Disclose the extent, if any, to which confidentiality of records identifying the participant will be maintained
- For research involving more than minimal risk, explain whether any compensation is available if injury occurs, whether any medical treatments are available if injury occurs, and if so, what they consist of and where further information may be obtained
- Explain whom to contact for answers to pertinent questions about the research, research participants’ rights, and whom to contact in the event of a research-related injury to the participant
- Disclose that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled

The following is a model consent form, which can be adapted to your specific project:
Informed Consent Document Template.

Child Assent and Parental Consent Form

When children/minors under eighteen are involved in research, assent must be obtained from both the parent and the child/minor. “Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent”. (45 CFR 46.402)

The language of the assent form should be geared to the cognitive level of the children being asked to participate in the research study. The minor should be given explanation of the proposed research procedures, the purpose of the research, and any discomforts, in language that is appropriate to the child’s age, experience, maturity, and condition. A particular child subject’s capacity to assent must be evaluated on an individual basis.

The following are model assent form and parental consent forms, which can be adapted to your specific project: