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Research using Humans as Subjects:

Consent Form Characteristics:

1. Concise
(more likely to be read)

2. Vocabulary and grammar appropriate for the subject population (more likely to be understood)

3. Includes:

a. Brief description as research
b. Duration of participation
c. Brief description of procedures distinguishing normal activities from research activities
d. Risks
e. Benefits to society
f. Extent of confidentiality
g. Voluntariness and withdrawal procedures
h. Contact information for researcher, faculty advisor, and Research and Integrity Office.
i. IRB/exemption approval reference ID


Characteristics that will entail a delayed review and approval:

1. A consent form that has the appearance of a contract with an implication that the subject is committing to participation. A consent form is an ethical requirement, but not a legal document.

2. A consent form worded from the viewpoint of the subject: e.g. “I will take part in an interview with the researcher where I will be asked questions….”

3. Over use of the word “understand’ and it’s implications. For example, “I understand the risks associated with this research.” How could a subject know that they understand and sign a document stating that they do? This is a legalistic approach similar to a liability waiver.

4. Long and redundant

5. A consent form that is coercive

Suggestion - use the templates available at:

http://www.units.miamioh.edu/compliance/hs02_01_Applications.html#hsAppConsent




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