Consent Forms

There is a difference between informed consent and a waiver of rights. An informed consent solicits intellectual understanding from a person volunteering that they know what is about to happen and agree. The agreement does not say if what is about to happen is done with prudence and care they waive the right to sue. It is only an agreement that there is a rationale for the process. Informed consent should provide sufficient information relative to the research so that the participant has the capacity to make an intelligent decision.

The law states that people under 18 years of age lack the capacity to give consent to be a research participant. Therefore, for those subjects 18 years of age or older or if there is a question of a person's ability to give consent (regardless of age), appropriate psychological consultation and review should be obtained.

Language should be understandable at a seventh or eight grade reading level. The following information is required in order for a consent form to comply with OHRP standards:

• Researcher's name (title and position) and contact information (i.e., phone number, address or e-mail)
• Purpose of the study and procedures to be followed, including identification of those which are experimental
• Describe participation to subjects (i.e., what is involved in participation)
• Nature and amount of risk, or substantial stress or discomfort involved
• Benefits to be expected or knowledge hoped to be gained
• Appropriate alternative procedures that might be advantageous to the subject, if any.
• Opportunity to ask questions before consenting
• Voluntary nature of participation and freedom to withdraw at any time without prejudice
• A statement as to how data will be handled and how confidentiality/anonymity will be maintained.

The consent form should NOT include ANY language through which the subject is made to waive (i.e., give up), or appear to waive any of his/her legal rights, or to release the institution or its agents from liability for negligence.

Verbal or Informational Consent (no signature is required from subject/participant)

Subjects must be informed of the same information they would be provided in a written consent form and told that by participating in the project, they are giving their consent.

In Other Words: (Here's an even "shorter" or "simpler" version of what to put in your consent forms)

• Who you are
• What you are doing
• Why you are doing it
• What subjects are asked to do and how long it will take
• Benefits/Risks to participation
• Participation is voluntary
• No penalty for nonparticipation/withdrawal from study
• How confidentiality/anonymity will be handled
• Who to call if any questions regarding research design

Note: Additional elements are required, as appropriate, if activities exceed minimal risk.