IRB New Member Orientation Presented by Sara Horn, Assistant Director of the Office for Research Protections.

IRB New Member Orientation Presented by Sara Horn, Assistant Director of the Office for Research Protections

Agenda for Today’s Orientation General overview of Penn State’s Human Research Protections Program (HRPP) and Institutional Review Board (IRB) Program General Information about IRB Structure and Function Go through PSU IRB Member Roles and Responsibilities Overview of Ethical Principles, Federal Regulations, PSU 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 CATS IRB and perform review activities (By CATS IRB Team member)

Penn State’s Human Research Protections Program (HRPP) Penn State’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 2014 and the accreditation given in 2015 is good for 5 years All locations for PSU accredited jointly

An HRPP is more than just the IRB…

Penn State’s IRB Program Two IRB Offices Human Subjects Protection Office- located in Hershey and covers the PSU College of Medicine (including the regional campus), the Penn State Hershey Medical Center Office for Research Protections- Where we are right now. Covers University Park Campus as well as all other commonwealth campuses (so everything but what the HSPO covers)

Office for Research Protections (ORP) Comprised of several programs: IRB Program (Human Subjects Research) Conflict of Interest Program (Individual, Institutional, Faculty Consulting) “ABI” Program – IACUC (Animals in Research) – Biosafety – Isotopes Education Program (Responsible Conduct in Research) Research Misconduct Program Research Compliance Management Systems Program (aka CATS Team)

IRB Program Leadership Candy Yekel, Associate Vice President for Research, Director of ORP, Institutional Official Debra Thurley, Director of Research Compliance Sara Horn, Assistant Director of the ORP, “IRB Director” IRB Chairs Tracie Kahler and Joyel Moeller, Senior IRB Program Leaders Stephanie Krout, IRB Program Coodinator

IRB Program Staff IRB 1 Team Tracie Kahler, Senior IRB Program Leader – Jodi Mathieu, IRB Analyst – Julie James, IRB Analyst Peggy Lorah, IRB Chair IRB 2 Team Joyel Moeller, Senior IRB Program Leader – Philip Frum, IRB Analyst – Courtney Whetzel, IRB Analyst Barry Ruback, IRB Chair

IRB Structure Requirements As per federal regulations and our Federal Wide Assurance, an 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 46.107 for complete information on all of the required qualifications to properly compose an IRB.

Our IRB’s We have two of IRB’s that review all types of research – Historically, we had a biomedical IRB and a social science IRB – Made up of approx. 7-12 full members at any given time, with a list of approx. 20 alternates who can substitute as needed Always have at least one nonscientist and non-affiliated member on roster (sometimes one person fills both roles)

Our IRB’s – “IRB Director” serves on both IRB’s as 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

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. For more information see PSU Policy RP03 at https://guru.psu.edu/policies/RP03.html https://guru.psu.edu/policies/RP03.html

IRB Meeting Schedule Each IRB is scheduled to meet once per month Schedule can be located at http://www.research.psu.edu/orp/humans/ab out-irb/irb-dates http://www.research.psu.edu/orp/humans/ab out-irb/irb-dates Occasionally have to convene a meeting outside of those dates Meetings may be cancelled if we have no agenda items

IRB Member Roles and Responsibilities

Appointment, Evaluation and Removal Appointment – IRB members are appointed throughout the year as a need arises on a committee – IRB members are not officially appointed until they have completed the following: This in person New IRB Member Orientation The required CITI humans subjects and DON modules Evaluation – IRB members are evaluated on a yearly basis and will receive feedback regarding the evaluation – Members also receive a yearly survey “IRB Member Self- Evaluation” where they can share information regarding IRB membership

Appointment, Evaluation and Removal Removal – Each term is set for 2 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

IRB Member Agreement Provided to you for signature on a yearly basis Read carefully to understand the requirements outlined, I will highlight just a few points today 1.Members are expected to attend committee meetings regularly 2.Members are expected to keep information provided to them for review and discussed by the IRB confidential 3.Members are expected to be available, within reason, to conduct alternate or “designated” reviews (Not typical for nonscientist members) 4.Members are expected to respond to correspondence promptly 5.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

IRB Member Roles Scientist – Expected to conduct scientific review as it relates to the criteria for approval – A majority of our IRB members are scientific Non-Scientist – Not expected to have knowledge of scientific method and do not perform scientific review (Will not serve as primary reviewer on a subcommittee) – Can take the view point of participants viewing materials Non-affiliated – Specific viewpoint of one who has no relation to the University

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)

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 Slides are placed in box.psu.edu folder for access by all members later – Publications available at meetings – Invitation to webinars hosted by the ORP (presented by outside entities) – Workshops offered by the ORP as listed here http://www.research.psu.edu/training/research- protections-workshops http://www.research.psu.edu/training/research- protections-workshops

Ethical Principles, Federal Regulations, PSU Policies, HRPP Toolkit

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) https://www.youtube.com/watch?v=86zWBjDaX Pk https://www.youtube.com/watch?v=86zWBjDaX Pk

History 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

Types of submissions reviewed by the Comittee New Study (Study) Modification to approved research (MOD) Continuing Review(CR) Modification/Continuing Review (MOD/CR)

HRPP Toolkit Lingo Toolkit documents can be accessed via the CATS IRB Library at irb.psu.edu 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

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)

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 – PSU Not Engaged Determinations – Exemption Determinations – Expedited Reviews

Regulatory criteria 2a Risks to participants are minimized by using procedures which are consistent with sound research design and which do not necessarily expose participants to risk.

Things to consider when evaluating RISK Scientific Merit Review-Review the study design as it relates to the risk/benefit determination Risks can be physical, social, legal and economic 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?

Things to consider when evaluating RISK 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?

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 – Importance of knowledge to be gained Are medical or psychological resources available if necessary?

Regulatory Criteria 2b Risks are minimized, whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.

Things to consider when evaluating RISK Consider all types of risk again. Are procedures being done anyway that will answer the research question and can the information from that data be used instead of exposing the participant to additional harm?

Regulatory Criteria 2c Risks to participants are reasonable in relation to potential benefits, if any, to participants and to the importance of knowledge that may reasonably be expected to result.

Things to consider when evaluating RISK Consider all types of risks. What does the IRB consider the risk level to be? What does the PI consider the risk level? Is there a possibility of a direct benefit? Is the hypothesis clear and understandable?

Things to consider when evaluating RISK 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? Is it worth exposing participants to risk? Will the research contribute to generalizable knowledge?

Things to consider when evaluating RISK 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

Regulatory Criteria 2d Participant selection is equitable

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?

Regulatory Criteria 2h 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.

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)

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, military – Socially disadvantaged – Economically disadvantaged

Things to consider when evaluating VULNERABLE POPULATIONS 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?

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?

Regulatory Criteria CONSENT 2i 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.

Things to consider when evaluating CONSENT Is the PI requesting to waive or alter any informed consent requirement? – Waiver of written documentation of consent Implied Verbal – Waiver or alteration of consent process No consent Passive/opt out (e.g. sign if you don’t want your child to participate) Deception (can’t reveal true purpose-waiver of elements of consent typically)

Regulatory Criteria CONSENT 5a The investigator will obtain legally effective informed consent of the participant or the participant’s legally authorized representative.

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?

Regulatory Criteria CONSENT 5b The circumstances of consent provide the prospective participant or their legally authorized representative sufficient opportunity to consider whether or not to participate.

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?

Regulatory Criteria CONSENT 5c The circumstances of consent minimize the possibility of coercion or undue influence.

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 – Recruitment and materials, Payment??

Regulatory Criteria CONSENT 5d The information that is given to the participant or their representative is in a language understandable to the participant or the representative.

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?

Regulatory Criteria CONSENT 5e 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.

Things to consider when evaluating CONSENT Is the information factual (e.g., the policy, plan, expectation or law)? Does the information avoid stating an outcome (e.g., something will or will not happen)?

Regulatory Criteria CONSENT 2j Informed consent will be appropriately documented in accordance with and to the extent required by the regulations.

Things to consider when evaluating CONSENT Long Form(most typically referred to as signed consent) – All elements of consent required – Adequate opportunity to read it before signed – Participant or representative will sign – If FDA regulated study, will also date. – A copy given to participant

Things to consider when evaluating CONSENT Short Form (not used often): – Elements presented orally – Witness to the presentation – Written summary contains required elements – Summary signed by witness and person obtaining consent – Consent signed by participant/representative and witness – If FDA regulated study, will also date. – Copy of the consent and the summary given to participant

Regulatory Criteria Monitoring 2e 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.

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?

Regulatory Criteria Privacy 2f There are adequate provisions to protect participant privacy.

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?

Regulatory Criteria Confidentiality 2g There are adequate provisions to maintain data confidentiality.

Things to consider when evaluating confidentiality Is confidentiality pledged? 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?

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)

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 for PI to keep on file Electrical equipment- safety inspection letters to be obtained and PI to keep on file PHI- HIPAA regulations apply-Waiver of Authorization? FDA- IND or IDE needed?

What will not be covered today All criteria for vulnerable populations FDA IND/IDE, Significant or Non-Significant Device Determinations Specific additional federal agency criteria Elements of consent, including waiver of written documentation or waiver or alteration of consent process …There just isn’t enough time!!!

Brief Overview of Committee Review Process 1.IRB staff pre-review submission, determine submission to require review by committee 2.Submission placed on agenda and subcommittee members assigned 3.Agenda for meeting sent to members via CATS IRB approx. 2 weeks prior to the meeting date 4.One week later, comments and suggested modifications are due from subcommittee members 5.IRB staff compose email to Primary Investigator (PI) 6.Investigator has 2 days to respond to subcommittee items 7.IRB staff notify members that PI has responded to subcommittee items 8.IRB members review most up to date materials prior to meeting 9.Submission reviewed at meeting

Looking at the Meeting Agenda You will receive a notification when the agenda for a meeting is ready via CATS IRB – Will include a reminder regarding COI and the definition of research – Will list old meeting minutes for member to review for any revisions – Will list submissions for review in the order in which they are to be reviewed For each study, it will list who the primary and secondary (subcommittee) reviewers are Will list approximate time for review for new studies and modifications (we invite PI’s to participate by phone to answer questions from the IRB) Will tell you as the members what worksheets and checklists are applicable to this submission and should be reviewed when reviewing documents – At times, you will find attachments to the agenda with other pertinent information

During the meeting Primary reviewer gives a summary of the submission and provides their outstanding concerns – Secondary reviewer adds to this IRB chair will guide the discussion, focusing on the criteria for approval-all members may participate Will review additional checklists for specific determination if applicable to the submission at hand Voting (led by chair) – Motion must include: Approved, approved with modifications, deferred, disapproved, suspended, terminated – If mods required to secure approval, the IRB must be specific with regard to the required modifications as this is still an approval by the board (IRB staff will review the revisions by PI to ensure they are exactly what the IRB requested) Length of approval (typically one year as required by federal regulations but can be less) Risk level (minimal risk or greater than minimal risk) Meeting minutes will be taken by IRB staff with input by IRB members

After the Meeting IRB staff will communicate review decision, required modifications, etc to the PI/research team IRB staff will send final approval letter once this is determined to be ready PI goes on their merry way conducting research…until they need to submit a modification to the research!

Alternate or Designated Reviews Once in a while, members (typically scientific) will 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, please follow these carefully and use the IRB Reviewer Guide to assist you where necessary. Note that a designated reviewer can never disapprove research on their own, this must be done by the committee, if applicable

CATS IRB Overview Presented by CATS IRB Team Member

Additional References Helpful to New Members Citi.psu.edu (To access required training modules) irb.psu.edu (To access CATS IRB once your access account is approved/activated) http://www.research.psu.edu/orp/humans http://www.hhs.gov/ohrp/humansubjects/ind ex.html http://www.hhs.gov/ohrp/humansubjects/ind ex.html

Any Questions? Please contact the following individuals: – Sara Horn, sjh246@psu.edu - Membership questions or overall review questionssjh246@psu.edu – Your IRB Chair - IRB questions like approval criteria, review questions, etc – Stephanie Krout (IRB Program Coordinator), sqk2@psu.edu - Attendance for meetings, membership info, etc sqk2@psu.edu – irbadmin@psu.edu - Issues with CATS IRB irbadmin@psu.edu

IRB New Member Orientation Presented by Sara Horn, Assistant Director of the Office for Research Protections.

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IRB New Member Orientation Presented by Sara Horn, Assistant Director of the Office for Research Protections.

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