Welcome to the IRB

1. Welcome to the IRB

2. IRB ORIENTATION New Member Helen Panageas, CIP Associate Director www.med.nyu.edu/irb

3. What we will Cover Today • What is the IRB • …and how does the IRB work? • Mechanics: the process… 10 minute BREAK • Mechanics: how to review a protocol, review strategies and meeting time 10 minute BREAK • History and Regulations • Research ethics & essence/spirit –a bit distilled • Commonly Vexing Details • Wrap – Up: Questions, issues, considerations, and last words….

4. What is an IRB? • An Institutional Review Board (IRB) is a group of people formallydesignated (by feds and Institution) to review and monitor research involving human subjects. • Direct arm of the federal government when it comes to protection of human subjects New York University School of Medicine has three IRBs

5. What is the IRB? • The purpose of the IRB is to protect the rights and welfare of individuals who are participating as subjects in research. • The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects.

6. What is an IRB? Federal Government says: An Institutional Review Board is a federally mandated group required to review and approve human research projects in accordance with Title 45 Public Welfare DHHS, PART 46 PROTECTION OF HUMAN SUBJECTS and FDA regulated studies in accordance with TITLE 21 FOOD AND DRUGS, PART 50 PROTECTION OF HUMAN SUBJECTS, PART 56 INSTITUTIONAL REVIEW BOARDS

7. Federal Wide Assurance • NYU SoM holds a Federal wide Assurance (FWA)00004952 • The FWA assures that the Institution will be compliant with the federal regulations for the protection of human subjects for all research regardless of funding source • The FWA is also approved by OHRP

8. IRB Membership • At least 5 members • IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. Federal Regulations at 45 CFR 46.107

9. IRB Membership(Continued) • IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. Federal Regulations at 45 CFR 46.107(d)

10. IRB Membership(Continued) Consultant as Reviewers An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. Federal regulations at 45 CFR 46.107(f)

11. The Individual IRB Member It’s tough job but you add to the process • Your unique professional and personal perspective. • This includes your scientific, social, ethical, community, minority, legal, administrative or operational perspectives, maybe all of these.

12. The Individual IRB Member • Members must attend a minimum of ten meetings annually, • should attend all meetings for which they are scheduled. • If a member is unable to attend a scheduled meeting, that member should inform the IRB Chair, Vice Chair, or an IRB Office staff member.

13. The IRB as a Privacy Board At NYU SoM The IRB is the Privacy Board What does that mean? The IRB makes all HIPAA findings

14. How does it Work?

15. Human Subjects Protection is a Shared Responsibility Investigator/Researcher IRB Institution

16. Team Approach

17. Institutional Official obligations: Sets tone for culture for respect of human subjects Serves as Signatory official on Federa-lwide Assurance Is Knowledgeable contact for OHRP/FDA Ensures effective communication and access to human subject information Ensures investigators fulfill responsibilities Facilitates educational activities Holds administrative responsibilities which include appoint IRB members and chair provide IRB with resources and staff support IRB authority and decisions

18. Institutional Obligations: Assure that the IRB has necessary resources to support the review of human subject research at the institution Assure autonomy of IRB decision making process Provide education and training in the responsible conduct of research for all researchers and key personnel Develop policies and procedures to administer human subject program Ensure assurances are in place and certification of IRB review submitted (include collaborating performance sites) Implement oversight to ensure compliance with regulations Promptly correct any situations of non-compliance with rules and regulations which could jeopardize research, funding, or reputation

19. IRB Chair role: Full knowledge of regulations and their application Maintain current knowledge of trends and changes in protection requirements Convene IRB meetings Perform review functions as needed for new, and continuing research Assist institution in review of non-compliance Perform “expedited review” and/ or designate experienced reviewers Assist in the education and development of IRB members Assure that documentation (minutes etc.) adhere to regulatory requirements Assure that all members have equal voice in meeting deliberations and voting Keep deliberations of IRB confidential

20. IRB panel obligations: Apply the rules and regulations to specific projects/protocols Provide constructive review of research proposals (in a timely manner) Assist with education of research community Respond to staff requests for attendance and information Communicate new developments to research community Seek outside consultation when lacking expertise Model exemplary research behavior

21. IRB member roles: Full knowledge of regulations and their application Maintain current knowledge of trends and changes in protection requirements Attend IRB meetings Perform review functions as needed for new, and continuing research Perform “expedited review” if designated Keep deliberations of IRB confidential

22. Principal Investigator Obligations Protect Human Subjects Know and apply rules and regulations Apply for prospective IRB approval Follow dictates of IRB Report unanticipated problems to IRB Report changes in research activities and ensure changes not initiated without IRB approval (except to eliminate immediate hazard to subject) Provide continuing reports of research Obtain informed consent/assent Retain records as required by regulation Train and supervise research team and associates

23. IRB Autonomy and Support Autonomy of IRB decision making is mandated by regulation and assured by the institution through the Federalwide assurance. (FWA) In essence, the IRB is a franchise of the federal agencies, OHRP and FDA when operating as a duly constituted IRB.

24. Review by Institution45 CFR 46.112 and 21 CFR 56.112 Research may be subject to “further appropriate review and approval or disapproval by officials of the institution. However, these officials may not approve the research if it has not been approved by an IRB.

25. System Integrity Team system is based on trust and open communication Issues and problems should be openly reviewed and addressed Complaints or problems should be handled fairly and efficiently The Primacy of the Rights and Welfare of subjects should guide us all decisions

26. How does it work? Basically: Protocols submitted for review IRB Admin Office processes review Reviews to ensure conformity to regulations and NYU policy Forwards all ‘full’ board reviews up to board IRB meets once a month (sometimes more by teleconference) to review and make decisions on new research and the continuation of research IRB also may, at times, have to make tough decision – disapprove, suspend, terminate etc..

27. How does it work? In detail: That is what we will discuss today How this IRB works Your responsibilities as a member History of research and the development of regulations and ethical principles

28. Mechanics Background Types of review How Review is determined Some IRB speak The Process Meeting materials What happens at the meeting Meeting Time Quorum Voting and COIs Review Process at the meeting and the Belmont

29. Types of IRB Review Exempt Expedited Full

30. How is Review Type Determined? Four Basic Questions: Is the Proposed project Research? Does the proposed project involve Human Subjects? What type of Riskis involved in the proposed project? Does the proposed project meet the criteria for the Review Category?

31. Is the Proposed Project Research? Researchis defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

32. Are Human Subjectsinvolved ? Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains Data through intervention or interaction with the individual, or Identifiable private information.

33. What is the Type of Risk? Minimal Risk is defined as the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

34. Review Categories Three Review Types: Full, Expedited, Exempt Only Expedited & Exempt have Review Categories

35. The level of review depends on the risk to the human participants. Review Continuum Risk:LowMinimal Higher Review:Exempt Expedited Full Informed Consent: NoneMay be WaivedRequired

36. Review Determinations Who makes it? PI Designees of the Chair What does it mean? Exempt- review by designee Expedited- review by designee Full Board- IRB meeting review

37. And then there’s ……… HIPAA

38. PHI18 Identifiers Names/Initials Postal Address Dates (DOB, DOA, DOD) Telephone numbers Fax numbers E-mail address Social Security Number Medical Record Number Health Plan Numbers Account Numbers Certificate/License numbers VIN including license plate numbers Device identifiers Web URLs Internet Protocol address Biometric identifiers Photographs and comparable images Any other unique identifying number, characteristic, or code

39. Some IRB Speak AE- Adverse Event CFR - Code of Federal Regulations CIP- Certified IRB Professional COG- Children’s Oncology Group COI- Conflict of Interest DSMB - Data Safety Monitoring Board GOG- Gynecologic Oncology Group HDE- Humanitarian Device Exemption HIPAA- Health Insurance Portability and Accountability Act UAP- Unanticipated Problem PHI – Private/Protected/Public Health Information

40. The Process

41. Mechanics of the process About 2 weeks prior to the meeting, an RSVP is sent via email. If you don’t use your email, give us an alternative method by which to communicate with you. If you are an alternate you are expected to attend if the member you are assigned, can not attend.

42. Your Review Materials Applications, attestations, signatures Protocol summary – lay summary Detailed protocol – typically authored by sponsor or the PI Recruitment materials: ads, letters, flyers Diaries, information sheets Consent and assent documents NIH grant document Drug/device brochures Additional review requirements: Nursing, Biomedical Engineering, Radiation Safety

43. Your Review Materials Initially daunting but you’ll soon be able to move through them quickly. Check your assignments. If you are primary or secondary – read in depth. Otherwise, review the protocol summary, the consent forms and any advertisements. Feel free to add to any discussion regardless of your assignment.

44. Your Review Materials The Reviewer’s Checklist Why was it created? Function Do you need to fill it out? Do you need to hand it in?

45. BREAK

46. How to Prepare

47. Who Is the IRB Again? Human subjects protection committee Scientific review Ethical review NOT A DSMB NOT the OCT or SPA NOT Research Compliance

48. Do a little Quality Control The IRB, reviewing from the principal perspective of human protection, begins with a scientifically sound clinical trial Bad science = bad clinical trial Good science ≠ good clinical trial

49. Who is Vulnerable? The research involves VULNERABLE research participants any time some or all of the subjects are likely to be vulnerable to coercion or undue influence. Populations: • Pregnant women, Prisoners, Children, • Mentally Disabled persons, Economically or educationally disadvantaged persons • What about: limited English proficiency, employees, students, end-of life cases, etc. ??? What Must be Done? • Always consider vulnerability of individuals/groups (PI protocol/application and IRB review) • Document considerations where practical/notable (PI protocol/application and IRB review) • Document required findings (IRB level only): • Pregnant women • Prisoners • Children

50. IRB Review Requirements In order for a project to receive IRB approval the IRB Board and reviewers must review and document certain findings according to the Federal Regulations. Research CANNOT be approved unless these findings can be made.