Cutting Through the Red Tape:

1. Cutting Through the Red Tape:

2. Objectives Provide practical and technical assistance for navigating the IRB process. Provide an explanation as to the regulatory requirements necessary for IRB approval.

3. Objectives Provide an overview of the informed consent process. Provide useful tips for writing an informed consent document.

4. Human Subjects Research

5. Human Subject Research

6. Definition of Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.202

7. Definition � Human Subject A living individual about whom an investigator conducting research obtains: data through intervention or interaction with the individual,  -or- identifiable private information. 45 CFR 46.202

8. IRB Purpose The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. IRB Guidebook � OHRP � Department of Health & Human Services

9. Getting Started

10. Getting Started Review the IRB forms Determine whether other committee approvals are required for study approval Allow yourself enough time to complete the required paperwork, obtain the necessary signatures, and obtain the required committee approvals Once approved, keep track of all expiration dates

11. IRB Review Process Human Subjects Research Exempt Research Expedited Review Full Board Review

12. Is it human subjects research?

13. Exempt Research Research that is �exempt� : Research in established or commonly accepted educational settings, involving normal educational practices Educational tests, surveys, interviews, or observation of public behavior unless identified and sensitive Research using existing data, documents, records, pathological specimens, or diagnostic specimens, if publicly available or unidentifiable 45 CFR 46.110(b)

14. Exempt Research Exemptions must be verified by a trained and qualified institutional official Exemptions may not be determined by the investigator

15. Expedited Review Eligible research includes minimal risk and: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes Collection of data from voice, video, digital, or image recordings made for research purposes Research on individual or group characteristics or behavior or research employing survey, interview, oral history, etc. methodologies 63 FR 60364 - 60367

16. Expedited Review Expedited review is not a quick review. Review is the same as that performed by the convened Board only the number of reviewers is different.

17. Full Board Review Requires full committee to meet in person and review the study Quorum must be present Non-Scientist must be present

18. IRB Review Criteria Risks to subjects are minimized and reasonable in relation to anticipated benefits: Risks to subjects are clearly and accurately identified and considered Risks to others (relatives, friends, etc.) are accurately identified and considered Risks are minimized through sound research design

19. IRB Review Criteria Risks to subjects are minimized and reasonable in relation to anticipated benefits: Research personnel are qualified Anticipated benefits to subject and importance of knowledge to be gained are clearly and accurately identified

20. IRB Review Criteria Selection of subjects is equitable: Minority/ethnic representation is appropriate Gender representation is appropriate Recruitment methods and advertising materials are non-coercive and appropriate Additional protections for children, pregnant women, fetuses, neonates, and prisoners

21. IRB Review Criteria Informed consent will be sought from each prospective subject or their legally authorized representative.

22. IRB Review Criteria Adequate provisions for monitoring the data collected to ensure subject safety Greater than minimal risk studies Internal and/or external data safety monitoring Data Safety Monitoring Board or Data Monitoring Committee

23. IRB Review Criteria Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data Methods for obtaining, recording, and coding of data and/or samples are described and satisfactory Storage of data and/or samples is described and satisfactory

24. IRB Review Criteria Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data Procedures for sharing of data and/or samples are described and satisfactory

25. IRB Review Criteria Additional safeguards included to protect the rights and welfare of vulnerable subjects: Children Adults with impaired capacity for decision-making Pregnant women and fetuses Neonates Prisoners Other

26. IRB Review Decisions Approved Modifications Required Tabled/Deferred (Full Review Only) Disapproved (Full Review Only)

27. Informed Consent:What is it? A process/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.

28. Informed Consent:Forms vs. the Process Informed consent is a process. Written informed consent is a requirement unless waived by an IRB. Meeting this requirement does NOT relieve researchers of their ethical duty to obtain meaningful consent, if written consent alone is not effective.

29. Informed Consent:Why is it so Important? Informed consent is giving people the opportunity to decide what will and will not happen to them. Subjects need to know what they are getting themselves into.

30. Informed Consent:Why is it so Important? Effective informed consent means the researcher understands their audience/target population. Non-English speaking? Blind? Upset?

31. Steps in the Informed Consent Process Recruitment When and where does it happen? Who is the first to approach or interact with the prospective subject?

32. Steps in the Informed Consent Process Disclosure What is your consenting format? e.g. read to them Note: The person who best understands the consent document may not always be the responsible investigator. Are other staff members involved? How have they been trained?

33. Steps in the Informed Consent Process Discussion Allow enough time for questions. Take subjects� concerns seriously.

34. Steps in the Informed Consent Process Assessment of Understanding Ask if the subject understands what they are expected to do and how often. Asking questions of participants vs. asking if they have questions.

35. Steps in the Informed Consent Process Post-enrollment Feedback The RI, CI, staff, and subjects must report all changes, adverse events and/or problems. Post-enrollment Disclosure Investigators have a moral responsibility to disclose new information that could affect subjects. Remind them they have the right to withdraw.

36. Steps in the Informed Consent Process Post-enrollment Dissemination Do subjects want a copy of your final report? Did they have that option at the very beginning? Report in a manner that protects subject identity/privacy.

37. Privacy & Confidentiality Privacy - having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality - methods used to ensure that information obtained by researchers about their subjects is not improperly divulged.

38. Informed Consent Process RESEARCHERS MUST� Provide subjects with sufficient opportunity to consider whether or not to participate. Eliminate coercion or undue influence. Use language that is understandable to the subject. Not include exculpatory language through which the subject is made to waive, or appear to waive, any legal rights. Not include language which releases, the investigator, the sponsor, the institution, or its agents from liability for negligence.

39. In summary, IRBs review� Study Design Recruitment Subject Population Informed consent document and process Risk/Benefit Ratio Privacy & Confidentiality Data Storage/Protection Protections for Vulnerable Subjects

40. Helpful Hints Know your research and methodology Know the potential ethical issues associated with your research Use the correct and current version of the IRB forms Be consistent throughout the application Answer all questions in the application fully and completely

41. Helpful Hints Write to your audience In general, write consent form at the 6th to 8th grade reading level; however, consider your subject population Make clear in the application who will be obtaining informed consent, and how

42. Helpful Hints Proof read all documents before final submission to the IRB Contact the IRB if you have any questions Be prepared to receive feedback from the IRB Plan ahead Know the committee deadlines

43. Contact Information Case Institutional Review Board Isabel S�nchez, IRB Director 10900 Euclid AvenueSears Library 657 Location Code: 7230 Cleveland, Ohio 44106-7230(216) 368-6993 ias5@cwru.edu

44. Contact Information Case Cancer Institutional Review Board Mariesa Malinowski, Administrative Director School of MedicineHarland Goff Wood Building Location Code: 7230 Cleveland, Ohio 44106 (216) 368-3771 Mariesa.malinowski@case.edu

45. Contact Information Cleveland Clinic IRB Deborah McCleave, IRB Manager 9500 Euclid Avenue Wb-2 Cleveland, Ohio 44195 (216) 444-2924 irb@ccf.org 

46. Contact Information Louis Stokes Cleveland VA Medical Center IRB Deborah Fox, IRB Administrator 10701 East Blvd. 151W Cleveland, Ohio 44106 (216) 791-3800 ext. 4624 deborah.fox2@va.gov http://www.cleveland.med.va.gov/research/irb.htm

47. Contact Information MetroHealth System IRB Kathy Lawry, IRB Manager 2500 MetroHealth Drive Rammelkamp 103 Cleveland, Ohio 44109-1998 (216) 778-2077 klawry@metrohealth.org http://mhirb.metrohealth.org/IRB

48. Contact Information University Hospitals of Cleveland Institutional Review Board 11100 Euclid Avenue Cleveland, OH 44106 (216) 844-1529 clinicalresearch@uhhs.com http://www.uhhs.com/DisplayContent.aspx?pageID=339&MID=3

49. Questions?