1. T HE I NFORMED C ONSENT Z ONE Patricia S. Kerby, MPA Office of Research Compliance September 10, 2008

2. P RINCIPLES OF I NFORMED C ONSENT Researchers must make sure patients understand the difference between clinical research and standard therapy.

3. P RINCIPLES CONT. All participants in patient oriented clinical research must participate in an informed consent process. This process must include: A statement that they are participating in a research study. Purpose- disclosure of aims, procedures, risks and benefits. It should explain randomization and placebo.

4. P RINCIPLES CONT. Study participation is voluntary. Potential subjects must be informed that there are alternatives to participation.

5. To increase patient comprehension, clinical researchers and their staff should use lay language at about the 8 th grade reading level.

6. The investigator must present the cost-benefit ratio for the patient and for society. This includes: Benefits Risks Costs Compensation The patient must be able to explain the difference between the clinical study and standard therapy.

7. Disclose the consequences of early termination by the patient, investigator, or sponsor.

8. Clinical investigators and their staff protect the confidentiality of the study participants.

9. Test the comprehension for the patient thru verbal and written questions. Repeating information helps patients understand

10. Follow institutional requirements- Patient must receive a signed and dated copy of the consent form.

11. Give the patient time to talk with significant others about being in the study. Give the patient time to read and reflect upon the consent form Introduce a waiting period between reading and signing the consent form Encourage questions Indicate that the study is only one of several treatment alternatives

12. Clinical investigators assume responsibility for the human subject’s welfare during and after informed consent. The informed consent process is only one part of the investigator /research staff and patient relationship.