Consent Form Guidelines

(Adapted for Psychology 201 and 301)

Consent forms document that the research project has been adequately explained to the subject. Consent forms need to be written in clear, concise, non-technical language, and must follow these guidelines:

(1) Be duplicated on institutional or department letterhead.

(2) Have spaces to enter the approval date in the upper right hand corner:

Approved: __/__/__, IRB, University of Puget Sound.

After approval by the IRB, the approval date must be typed in the upper right corner.

(3) Have one of these general titles:

Consent to Act as a Subject in an Experimental Study
Consent to Act as a Subject in a Research Study

(4) List all investigators with names and telephone numbers. Non-faculty members must list their faculty sponsor(s).

(5) Provide a space for the subject's initials in the lower right corner of each page except for the page containing the subject’s signature. Pages must be numbered.

(6) ******** Use asterisks to separate the section using "you" from that using "I".

(7) One copy of the consent form must be placed in the project file, and another copy must be given to the subject.

(8) Informed Consent for Competent Adults and Adolescents must be formatted with the following standard paragraph subtitles. This format assists the reviewers and the investigator to insure that all required information is included.

Description

The first two sentences should give a brief, non-technical explanation of the study and identify why a particular subject is asked to be in the study. (Example: The purpose of this research is to determine if people of various ages and with different types of illnesses have different problem-solving skills.) The remainder of the description should include:

  • Purposes and Goals
  • Approximate number of subjects (sex and age range) and duration of participation
  • Time sequences for stages or steps in participation, rest periods when indicated
  • Tests or diagnostic procedures, and/or questionnaires

Risks and Benefits 

Include all reasonably foreseeable risks and discomforts. Such risks could be physical, psycho-social, or legal. Also mention precautions taken to avoid such hazards. Include any benefits to the subject or to scientific knowledge.

Costs and Payments 

Include any cost or payment to the subject, or reimbursement for related expenses. Mention any conditions affecting payment and time of payment.

Confidentiality 

Assurance of protection of confidentiality must be included. Describe your plans, then include appropriate sections of the standard statement.

Right to Refuse or to End Participation 

The suggested paragraph should be adapted to your protocol.

Voluntary Consent 

The standard paragraph should be on the same page as the signature.

Investigator's Certification 

Also on same page.