1. IRB New Member Orientation
LSUHSC-S’s HRPP is accredited by The Association of Human Research Protection Programs (AAHRPP).

2. Agenda for Orientation
General overview of LSUHSC-S’s Human Research Protections Program (HRPP) and Institutional Review Board (IRB) Program
General Information about IRB structure and function
Go through LSUHSC IRB member roles and responsibilities
Overview of ethical principles, federal regulations, LSUHSC-S Policies, HRPP toolkit that guide IRB review
Overview of review process and the use of the HRPP toolkit during the review
Overview of how to access SHIeLDS IRB and perform review activities

3. LSUHSC-S’s Human Research Protections Program (HRPP)
LSUHSC-S’s HRPP is accredited by The Association for Accreditation of Human Research Protection Programs (AAHRPP)
Accreditation process includes an evaluation of our HRPP policies and procedures in relation to AAHRPP set of standards. Includes a 3 step process that takes approximately 1 year to complete and includes an on site visit.
Last re-accreditation process and site visit occurred in and is good for 5 years (2017)

4. Human Research Protections Program
An HRPP is……..
HRPP
Human Research Protections Program
Institutional Review Board
Institutional Official
Investigators & Research Staff
Conflict of Interest
Ancillary Reviews
Contracts & CTMT

5. IRB One IRB Office Human Subjects Protection Office is located at:
LSU Health Sciences Center
Clinical Research Building Rm# 124
1501 Kings Highway
Shreveport, LA
Covers the LSU Medical School

6. HRPP Comprised of several programs: Institutional Review Board
Conflict of Interest Program (Biomed, Radiation Safety, Scientific)
Ancillary Reviews
Education Program & Outreach
Clinical Trial Management Team
HRPP QA/QI

7. IRB Staff
Aliese Seawright, Staff Director Allison Booth, IRB Chair Karen Johnson, IRB Analyst Twyla Balentine, IRB Analyst

8. IRB Structure Requirements
As per federal regulations IRB must:
have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution;
make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women;
include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas;
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; and
not allow any member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. Please see the regulations at 45 CFR for complete information on all of the required qualifications to properly compose an IRB.

9. Our IRB We have one on-site IRB that reviews all types of research
Made up of approx. 13 full members at any given time
Approximately 18 alternates who can substitute as needed
Always have at least one nonscientist and non-affiliated member on roster (sometimes one person fills both roles)

10. Our IRB “IRB Director” serves on the IRB as a regulatory expert
Each IRB has a Chair and a Vice Chair
Chairs and Vice Chairs have particular duties with regard to the IRB program and the HRPP

11. Authority of the IRB The IRB has the authority to:
Approve, require modification to secure approval, disapprove all research activities overseen and conducted by the organization;
Suspend or terminate IRB approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to participants;
Observe, or have a third party observe, the consent process; and
Observe, or have a third party observe, the conduct of the research.

12. IRB Meeting Schedule
The IRB is scheduled to meet once a week, except for holidays
Meeting schedule can be located at:
Occasionally have to convene a meeting outside of those dates
Meetings may be cancelled if we have no agenda items

13. IRB Member Roles and Responsibilities

14. Appointment, Evaluation and Removal
IRB members are appointed throughout the year as a need arises on a committee
IRB members cannot officially serve until they have completed the following:
In person New IRB Member Orientation
The required CITI humans subjects and COI disclosure
Removal
Each term is set for 3 years, however, many members serve multiple terms
Toward the end of the two year term, you will be contacted regarding renewing or ending your term on the IRB
We will not renew someone’s membership after their 2 year term if they are not regularly meeting expectations outlined in the IRB Member Agreement

15. IRB Member Expectations
Provided to you on a yearly basis
Read carefully to understand the requirements outlined, I will highlight just a few points today
Members are expected to attend committee meetings regularly
Members are expected to keep information provided to them for review and discussed by the IRB confidential
Members are expected to be available, within reason, to conduct “designated” reviews
Members are expected to respond to correspondence promptly
Members should review information regarding conflicts of interest and should identify and make IRB staff/chair aware of conflicts and follow procedures to recuse themselves from voting on a particular study

16. IRB Member Roles Scientific Member Non-Scientific Member
Expected to conduct scientific review as it relates to the criteria for approval
Many of our IRB members are scientific
Non-Scientific Member
Can take the view point of participants viewing materials
Non-affiliated/Community
Specific viewpoint of one who has no relation to the University

17. IRB Member Roles All members in all roles:
Treat all oral, written and electronic information obtained as part of the review process as confidential
Know the definition of “Conflicting Interest”
Consider whether they have sufficient expertise to review the submission
Review the “Pre-Review” findings for each submission if any
Consider the criteria in all applicable worksheets & checklists

18. IRB Member Roles All members in all roles:
Review all materials prior to the meeting
Conduct alternate or “designated” reviews if requested by IRB staff
Respond to requests from IRB staff
May serve as a representative of a vulnerable population with whom they have expertise (as indicated in the HRP-202 form completed prior to appointment)
ARE EXPECTED TO APPLY AND FOCUS ON THE CRITERIA FOR APPROVAL, ENGAGE IN COLLEGIAL DISCUSSION, VOTE/RECUSE FROM VOTE/OR ABSTAIN FROM VOTE (if necessary)

19. Continuing Education
Continuing Education is expected of all IRB Members. Here is a briefing of the types of CE activities we offer:
Short educational sessions at the beginning of each IRB meeting
Information is ed for access by all members
Publications available at meetings
Invitation to webinars hosted (presented by outside entities)
Workshops offered periodically

20. Ethical Principles, Federal Regulations, LSU Policies, HRPP Toolkit

21. History
The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects.
Video on Belmont Principles (5:44)

22. In 1981, DHHS and FDA used the Belmont Report as the foundation for the development of the current human subjects regulations (45 CFR part 46)
Subpart A is often referred to as “The Common Rule”
Common Rule has been adopted by 18 Gov’t agencies, some have additional requirements as well

23. Types of Submissions Reviewed by the Committee
New Study (Study)
Modification to approved research (MOD)
Continuing Review(CR)
Modification/Continuing Review (MOD/CR)
Reportable New Information (RNI’s)

24. HRPP Toolkit Lingo
Toolkit documents can be accessed via the SHIeLDS IRB Library or at &Templates/index
HRP-XXX= Number given to a specific document, we make references to these often and I will do so today
Checklists HRP-4XX= Regulations require this documentation to be stored with the submission
Worksheets HRP-3XX= Use for review, but specific documentation of each point not required by regulations
SOPS HRP-0XX= Standard Operating Procedures of the IRB

25. Where to find the review criteria for approval
HRP-314 (Criteria for Approval)on screen/table during IRB Meetings
Additional worksheets and checklists in the HRPP Toolkit
Code of Federal Regulations
45 CFR 46 A, B, C, and D
21 CFR 50,56 (FDA)
21 CFR 312, 812 (FDA)
45 CFR 164 (HIPAA)

26. Types of Review Committee Review (We will focus on this today)
Anything that cannot be reviewed at non-committee level
Non-Committee Review
Not Human Subjects Research Determinations
Not Engaged Determinations
Exemption Determinations
Expedited Reviews

27. Regulatory Criteria
Risks to participants are minimized by using procedures which are consistent with sound research design and which do not necessarily expose participants to risk.

28. Things to consider when evaluating RISK
Study Design and Purpose
Risks to subjects are minimized, both physical and non-physical, through sound research design and do not unnecessarily expose subjects to risk
Can the scientific question be answered with less risky procedures?
Can the scientific question be answered with fewer procedures?
Can the scientific question be answered with fewer participants?

29. Things to consider when evaluating RISK
Study Resources
Adequate study resources
Are the investigators qualified to do the research?
Are there enough investigators/staff available to do the research?
Is there a process to ensure that research staff are trained to do the research and adequately informed of duties, etc. by the investigator?
Are the facilities adequate to conduct the research there?

30. Things to consider when evaluating RISK
Are the procedures consistent with sound research design?
Participant Selection
Randomization Process
Data Analysis Plan
Data Safety and Monitoring Plan – required for greater than minimal risk
Importance of knowledge to be gained
Are medical or psychological resources available if necessary?

31. Regulatory Criteria
Risks are minimized, whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.

32. Things to consider when evaluating RISK
Consider all types of risks
What does the IRB consider the risk level to be?
Is there a possibility of a direct benefit?
Is the hypothesis clear and understandable?
Can the research question be answered by the way that the study is designed?
Is the knowledge gained sufficiently important to justify the risks involved?

33. Things to consider when evaluating RISK
Is it worth exposing participants to risk?
Will the research contribute to generalizable knowledge?
Will it be possible for the investigator to recruit the required number of participants?
Is there sufficient time to conduct and complete the study?
Scientific Review by the IRB
All 3 criteria regarding risk relate to scientific review
Primary reviewer is to use HRP-320 to support their scientific review
Note: Non-scientists cannot be responsible for this, by definition

34. Participant selection is equitable
Regulatory Criteria
Participant selection is equitable

35. Things to consider when evaluating EQUITABLE SELECTION
Who is to be enrolled?
Look at inclusion/exclusion criteria
Does this group of enrollment relate to the purpose?
Where will the research be conducted?
Are vulnerable populations targeted because it’s easier?
Are persons vulnerable to coercion or undue influence?

36. Regulatory Criteria
When some or all of the participants, such as children, prisoners, pregnant women, physically or mentally impaired persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence additional safeguards have been included in the study to protect the rights and welfare of these participants.

37. Things to consider when evaluating VULNERABLE POPULATIONS
There are special reviewer guidelines for:
children (Subpart D in 45CFR46 and HRP-416)
pregnant women (Subpart B in 45CFR46 and HRP-412)
fetuses or neonates (Subpart B in 45CFR46 and HRP-413, 414)
prisoners (Subpart C in 45CFR46 and HRP-415)
Adults with cognitive impairment (HRP-417)

38. Things to consider when evaluating VULNERABLE POPULATIONS
Other participants who could be vulnerable to coercion or undue influence include:
Students
Subordinate groups , i.e. employees
Socially disadvantaged
Economically disadvantaged
If the previous groups are included, consider:
Is there a power differential?
Are there communication issues?
Is there a decisional issue?
Is there excessive motivation?

39. Things to consider when evaluating VULNERABLE POPULATIONS
Are appropriate protections in place to protect the rights and welfare of the participants when vulnerable populations are involved?

40. Regulatory Criteria CONSENT
Informed consent will be sought from each prospective participant or the participant’s legally authorized representative in accordance with and to the extent required by the regulations.

41. Things to consider when evaluating CONSENT
Is the PI requesting to waive or alter any informed consent requirement?
Waiver of written documentation of consent
When linked to identification
In the event it could cause harm
Waiver or alteration of consent process
No consent
Passive/opt out implied
Deception (can’t reveal true purpose-waiver of elements of consent typically)

42. Regulatory Criteria CONSENT
The investigator will obtain legally effective informed consent of the participant or the participant’s legally authorized representative.

43. Things to consider when evaluating CONSENT
Who can serve as a legally authorized representative?
Will the participant or their representative understand the facts?
Will they appreciate the implications of their decision?
Will they be able to decide and communicate that decision?

44. Regulatory Criteria CONSENT
The circumstances of consent provide the prospective participant or their legally authorized representative sufficient opportunity to consider whether or not to participate.

45. Things to consider when evaluating CONSENT
How much time/effort will be devoted to the consent discussion?
How much time will be allowed for a decision?
What is the setting of the consent process?

46. Regulatory Criteria CONSENT
The circumstances of consent minimize the possibility of coercion or undue influence.

47. Things to consider when evaluating CONSENT
Is there a power differential?
Are there communication issues?
Are there issues regarding the capacity to make a decision?
If appropriate, is there a child assent form?
Are there excessive motivating factors
Compensation

48. Regulatory Criteria CONSENT
The information that is given to the participant or their representative is in a language understandable to the participant or the representative.

49. Things to consider when evaluating CONSENT
What language does the participant or representative speak?
Can the research team communicate with the participant in an understandable language?
Will written information be given to the participant in an understandable language?

50. Regulatory Criteria CONSENT
The oral or written information does not include any exculpatory language through which the participant or their representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

51. Things to consider when evaluating CONSENT
Informed Consent congruent with:
Protocol
Policies
Laws

52. Regulatory Criteria CONSENT
Informed consent will be appropriately documented in accordance with and to the extent required by the regulations.

53. Regulatory Criteria MONITORING
If the research involves more than minimal risk to the participant, the research plan makes adequate provision for monitoring the data collected to ensure the safety of the participants.

54. Things to consider when evaluating MONITORING
Is the study considered to be greater than minimal risk, if not, this is not required.
When will the data be monitored?
What data will be monitored?
Who will be doing the monitoring?

55. Regulatory Criteria PRIVACY
There are adequate provisions to protect participant privacy.

56. Things to consider when evaluating PRIVACY
Will participants think that the information sought is any of the researcher’s business?
Will participants be comfortable providing information in the research setting?
Do procedures for identifying participants minimize any invasion of privacy?
Are the research procedures designed to minimize any invasion of privacy?

57. Regulatory Criteria CONFIDENTIALITY
There are adequate provisions to maintain data confidentiality.

58. Things to consider when evaluating CONFIDENTIALITY
Is confidentiality maintained?
Are there legal or ethical requirements to maintain confidentiality?
Will data release not cause risk or harm?
Is there restricted access (locks/passwords)?
Is a Certificate of Confidentiality planned or needed?
COC can be obtained via NIH for applicable studies to protect data from subpoena
Considered with really sensitive information
Are techniques used to protect the data from re- identification?

59. Additional Worksheets and Checklists to note
Vulnerable populations (as listed in previous slide)
Additional Federal Agency Criteria (HRP-318)
FDA-Non-Significant Risk Device Determination (HRP-418)

60. Other Considerations/Information
Blood/fluid/tissue collection or handling- Biosafety approval needed? IRB staff trigger this review and ensure completion prior to final IRB approval letter to PI
Collaborative research with other institutions- other agreements/approvals needed? IRB Analysts will handle other necessary reviews and help facilitate prior to final IRB approval letter to PI
Research in schools/ businesses-letters of permission required
PHI- HIPAA regulations apply-Waiver of Authorization?
FDA- IND or IDE needed?

61. Required Elements of Informed Consent
Statement that the study involves research and is voluntary
Subject may refuse or discontinue participation at any time without penalty or loss of benefits
Explanation of the purpose of the research
Explanation of expected duration of participation
Description of the procedures to be followed; identification of any procedures that are experimental
Any foreseeable risks or discomforts to subjects
Alternative procedures or courses of treatment; may be advantages to the subject
Extent to which confidentiality will be maintained
Possibility FDA may inspect records
If greater than minimal risk, whether compensation will be available
Medical treatments available in the event of an injury
Who to contact to for questions; subject’s rights, or in the event of a research-related injury

62. Additional Elements of Informed Consent (if applicable)
Particular treatment/procedure may involve risks to the subject (or to embryo or fetus if becoming pregnant)
Circumstances under which the subject is terminated from the study by the investigator
Additional costs to the subject that may result from research participation
Consequences of a subject’s decision to withdraw from the research
Significant new findings that may relate to the subject will be provided
Approximate number of subjects in the study
If the study involves genetic research (Genetic Information Nondiscrimination Act)
For applicable trials, a statement regarding will be provided

63. Alternate or Designated Reviews
Experienced members may be asked to serve as a Designated Reviewer for a Non-Committee review. If this happens to you, instructions will be provided by the IRB Analyst requesting the review.
Note that a designated reviewer can never disapprove research on their own, this must be done by the committee, if applicable

64. Any Questions? Please contact the following individuals:
Aliese Seawright, – IRB and SHIeLDS questions
Allison Booth, – IRB Chair for approval criteria, review questions, etc.