SOP Area: Auditingthe Informed Consent Process

SOP #: I-B-7

University of Pittsburgh

Education and Compliance

Standard Operating Procedure

Review of the Consent Document for the Elements of Informed Consent

1. PURPOSE

To define the procedure for reviewing informed consent documents to ensure that they contain the basic and additional (if applicable) elements of informed consent.

2. SCOPE

This activity applies to research studies with informed consent documents which have been initially approved by the IRB within the previous three years. Elements to be reviewed include: the eight basic elements, the six additional elements, elements for HIPAA authorization, reading complexity level, and correct phone numbers for the IRB and for the Human Protections Advocate.

3. RESPONSIBILITIES

Education and Compliance Coordinators for Human Subject Research are responsible for randomly selecting the protocol files for which consent forms will be reviewed, auditing the consent forms, recording the information on the attached data form and summarizing the results in a report to the IRB Executive Committee.

4. PROCEDURES

4.1. Consent forms,for studies that are designated for a compliance review, may be reviewed by completing the attached form.

4.3. Any omissions noted during the review will be brought to the attention of the PI and the IRB.

4.4. Findings may be included within the compliance activity report or directly sent to the IRB.

5. REFERENCES / DOCUMENTATION

Elements of Informed Consent Monitoring Checklist (attached)

SOP #: I.B.7

SOP Area: Monitoring of the Informed Consent Process

University of Pittsburgh

Education and Compliance Program RCCO

SAMPLE ELEMENTS OF INFORMED CONSENT MONITORING CHECKLIST SAMPLE

Date of Monitoring: ______

QA Number: ______Monitor: ______

Protocol Number: ______IRB Approval Date: ______

Investigator’s Name: ______Level of Risk: ______

Protocol Title: ______

Basic Elements

/ C Contained in the consent form document?
Y / N / NA / Comments
1 / A statement that the study involves research
2 / A A description of any foreseeable risks
3 / A description of any benefits
4 / A disclosure of alternative treatments
5 / A statement regarding confidentiality
6 / Statement regarding treatment or compensation for injury(for studies that involve more than surveys and questionnaires)
7 / Whom to contact for answers to questions about the research and the research subjects’ rights (investigators and Human Subject Protection Advocate)
8 / A statement that participation is voluntary

ELEMENTS OF INFORMED CONSENT MONITORING CHECKLIST (continued)

Additional Elements

Contained in the consent form document?

Y / N / NA / Comments

1 / A statement that that the particular treatment may involve risks to the subject (or to the embryo or fetus) if the subject is or may become pregnant
2 / Anticipated circumstances under which the subject’s participation may be terminated by the investigator (specifically)
3 / Costs and payments
4 / Consequences of a subjects decision to withdraw
5 / A statement that significant new findings which may relate to the subject’s willingness to continue participation will be provided to the subject
6 / The approximate number of subjects to be enrolled

Was the research related procedure described as: research or treatment ?

If the term treatment was used, please explain.

Was the informed consent document written at a non-complex reading level?

Human Protections Advocate Phone Number: Correct - Incorrect