Requirements for Informed Consent
Informed consent means the knowing consent of an individual without undue
inducement or any element of force, fraud, duress or any other form of constraint
Minimal information for informed consent:
1. General purpose of the research and a description of the
2. Statement that participation is voluntary and that the participant
may withdraw at any time without prejudice.
3. Explanation of whom to contact for answers to questions about the
4. If a signature is needed for the subjects, additional information
should be provided, including:
a. Duration of subject’s participation
b. Description of reasonably foreseeable risks
c. Description of benefits of the research
d. Disclosure of appropriate alternative procedures
e. Place for a signature and date
Research means a systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to generalizable
knowledge. Activities, which meet this definition, constitute research for purposes
of this policy, whether or not they are conducted or supported under a program
which is considered research for other purposes. For example, some
demonstration and service programs may include research activities.
Minimal risk means that the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine physical
or psychological examinations or tests.
Planning Council approved February 2, 2015.