EQuIP: Common Errors Informed Consent Protocol Deviations Study Documents

1. EQuIP: Common Errors ? Informed Consent ? Protocol Deviations ? Study Documents Eunice Yim Newbert, MPH

2. What is EQuIP? Education and Quality Improvement Program Mission to educate and update the research community of regulations regarding human subject protections � and of good clinical practices regarding research conduct and documentation

3. Who is EQuIP?

4. EQuIP: AIMS To Review � how research is conducted and documented To Learn � what are common study deviations and issues, and what are the obstacles to conducting compliant research To Educate � how to identify, correct and prevent study deviations and how to overcome the obstacles

5. EQuIP: AIMS We REVIEW research studies so We can LEARN What to EDUCATE so You, as part of the research community, can comply with, as well as improve upon, the policies and procedures regarding human subject protections and good clinical practices

6. Who do we review? All studies �

7. Completed Reviews Between 2/2004 � 9/2006 ? 60 Full Study Reviews Completed Selection: 87% (52) Random 10% (6) PI-requested 3% (2) IRB-requested (For-cause) Risk: 70% (42) Minimal 28% (17) Greater than Minimal 2% (1) N/A (adults only) Funding: 51% (31) Federal/State 13% (8) Industry/Corporate 12% (7) External Foundation 12% (7) Internal Foundation/CH Dept. 12% (7) No Sponsor

8. Common Errors We learned the most common errors made regarding documentation fell into 3 general categories: Protocol Deviations Study Documents, Files & Organization Informed Consent and Assent

9. Protocol Deviations

10. Protocol Deviations 85% of the reviewed studies � Did not identify all protocol deviations Did not adequately document all protocol deviations Did not properly report all protocol deviations

11. Types of Deviations

12. Significant/Minor Deviations

13. Study Documentation, Files and Organization

14. Study Documentation 60% CCI/IRB application submissions were incomplete or had inaccurate information 60% missing required CCI/IRB documents and submissions 73% no consistent method of capturing study data and/or organizing study documents

15. Study Documentation What you should have � ? Regulatory & CCI Documentation ? Copy of submissions and reviews for New Protocol, Continuing Reviews, 3-YR Rewrites, Amendments ? Complete Submission & Application, Dept. Scientific Review CCI/IRB Action Letters, PI Responses, Final Approval Letter ? Serious Adverse/Unanticipated Event Reporting ? Serious/Minor Deviation Reporting ? CCI/IRB Correspondence - pertinent to protocol ? Copy of all approved versions of the: Protocol, Informed Consent, Recruitment and Study Materials ? FDA Forms 1571 and/or 1572 - as applicable

16. Study Documentation

17. Study Documentation

18. Informed Consent and Assent

19. Informed Consent/Assent 33% used expired consent forms 40% had informed consent forms missing required signatures 43% did not have adequate documentation of assent process

20. Informed Consent Informed Consent is an on-going PROCESS in which... investigator discloses all relevant information potential subject has opportunity to ask questions investigator answers questions The Informed Consent Form is the documentation of this process.

21. Informed Consent No person may be involved in a research study unless the person, or person�s parent/guardian, has provided consent. Informed consent must be obtained and documented in the most current IRB-approved consent form prior to participation in any study-related activity.

22. Informed Consent HOW TO DOCUMENT THE INFORMED CONSENT PROCESS

23. Informed Consent Signatures Subject Parent/Guardian Principal Investigator/PI Associate Witness

24. Informed Consent Signatures Ensure everyone signs and dates the correct signature line If assent is required, have child sign and date the subject/participant line to document assent. If assent is not obtained, the reason must be documented on the consent form where indicated.

25. Informed Consent Signatures Ensure the parent/guardian specifies their relationship to the subject. If parental permission is required from both parents, ensure the consent form is formatted to include two separate signature lines.

26. Informed Consent Signatures PI may designate another research staff to obtain consent. Whoever explains the study to the subject must sign the PI/PI Associate signature line. PI/PI Associate must sign and the consent form only after the subject/parent/guardian signs the consent form. Ensure that PI/PI Associate documents to who the consent was �Explained to�.

27. Informed Consent DO NOT DATE ANOTHER PERSON�S SIGNATURE!! GIVE SUBJECT/PARENT A COPY OF THE SIGNED CONSENT FORM!! MAKE SURE YOU ARE USING A VALID CONSENT FORM � CHECK THE DATES! ? Validation dates (Activation date � Expiration date) can be found in the footer of each page of the informed consent form.

28. Questions? Eunice Yim Newbert 5-7052 Kristin Bowling 5-5308 www.childrenshospital.org/research/equip