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Elements of Informed Consent

The following elements must be included when obtaining informed consent (whether written or oral):

1. A fair and understandable explanation of the purposes of the research and expected duration of the subject’s participation;

2. A description of the procedures to be followed and identification of any procedures that are experimental in nature;

3. A description of any reasonably foreseeable discomforts or risks;

4. A description of the benefits expected;

5. A disclosure of appropriate alternative procedures (if any) that would be advantageous for the subjects;

6. A written (or oral) instruction that the “subject is free to withdraw his/her consent and to discontinue participation in the study at any time without prejudice from the investigator(s)”;

7. With respect to biomedical or behavioral research that may result in physical injury, an explanation as to whether compensation and medical treatment is available if physical injury occurs, and, if so, what it consists of or where further information may be obtained;

8. A statement (if appropriate) describing the extent to which confidentiality of records identifying the subject will be maintained;

9. An explanation of whom to contact for answers to pertinent questions about the research and who to contact to file a grievance;

10. The agreement (written or oral), entered into by the subject should not include any exculpatory language through which the subject is made to waive, or appear to waive, any of his/her legal rights, or to release the institution or its agents from liability for negligence;

11. All consent forms must have a signature line for the participant (or his or her legal representative);

12. A copy of the signed consent form and summary shall be provided to all subjects;

13. The principal investigator (and faculty supervisor, where appropriate) must be properly identified with a signature block that is to include name, rank, title, department status, and telephone number. For oral consent the identity of principal investigator must be disclosed to the participant.

Examples of different consent:

Adult Informed Consent (pdf)
Parent Informed Consent (pdf)
Child Assent (for children 6 to 18 years of age) (pdf)
Oral Consent (pdf)

 
 

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