(Section 50.25)

In seeking informed consent, the following information shall be provided to each subject:

1. A statement that the study involves research, an explanation of the purposes of the research, and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

2. A description of any reasonably foreseeable risks or discomforts to the subject.

3. A description of any benefits to the subject or to others, which may reasonably be expected from the research.

4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and noting the possibility that the FDA may inspect the records.

6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

7. An explanation of whom to contact for answers to pertinent questions about the research and the research subjects’ rights, and whom to contact in the event of a research related injury to the subject.

8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Summary of elements of an informed consent

• The purpose of the study

• The expected length of participation and procedures the participants will encounter

• The participant’s right to decline participation or withdraw once the study has begun without prejudice

• The foreseeable consequences of declining or withdrawing

• The foreseeable factors that may influence his or her willingness to participate in the study (including discomfort or adverse effects)

• Any potential benefits of the research

• Limits to confidentiality (i.e., access to data by research assistants)

• Incentives for participation (i.e., extra credit, money, free psychological treatment)

• The name of someone to contact to answer questions regarding participation

Sample Consent Form
This form is intended as a guide. Researchers should present the required information in the most appropriate format to the items enclosed in parentheses. Both the participant and researcher should retain a copy of the signed consent form. Note that research involving minors requires written consent from the parent/guardian and from the minor if the child is over seven years of age.

I consent to serve as a participant in the research investigation entitled (title). The nature and general purpose of the study have been explained and the attached statement has been read to me by (name of researcher), from (department). I understand the purpose of this research is (give a brief explanation), and that the research procedures involve (duration and experimental procedures).

The potential benefits and risks to participants in this project are (give brief explanation). I understand that my participation is voluntary and that all information is confidential and my identity (or the identity of my child) will not be revealed; I (or my child) am/is free to withdraw consent and to discontinue participation in the project at any time; any questions I/my child may have about the project will be answered at any time by the researcher named below or by an authorized representative.

The investigator named below has primary responsibility for ensuring that participants in research projects conducted under college auspices are safeguarded from injury or harm resulting from such participation. If appropriate, the person named below may be contacted for remedy or assistance for any possible consequences from such activities. On the basis of the above statements, I/my child agree(s) to participate in this project.

Participant’s Signature:
Participant's Name (printed):
Date:
Researcher’s Name:
Address:
Phone number:

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