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Office for Human Subject Protection Updates & Quiz Show
Jennifer Dolan, Emily Flagg, Tiffany Gommel, Kelly Unsworth & Kathleen Wessman
January 13, 2015
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RSRB Updates
RSRB Staff Turnaround Times Fee Schedule Policies & Guidelines Protocol Templates ROSS Upgrades
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RSRB Staff
Director – Tiffany Gommel Senior Specialist – Emily Flagg 5 Board Specialists:
Board 01 – Linda Palm-Montalbano
Board 02 – Kathleen Buckwell, Sr. Specialist (Exempt Chair)
Board 03 – Igor Milosevic Board 04 – Michelle Giglio Board 05 – Nicole Mason
Assistant Specialist – Suzanne Coglitore (Exempt)
Assistant Specialist – Jimmy Filingeri (Board 04)
Data Manager – Sue Flannigan
Board Secretary – Nilsa Hernandez
http://www.rochester.edu/ohsp/about/contactUs.html
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Turnaround Times 2014 metrics compared to 2013
2013 # Active Studies
2014 # Active Studies
2013 # new
studies
2014 # new
studies
2013 Median Time to
Approval (days)
2014 Median Time to
Approval (days)
Full Board 502 508 93 98 33 18
Expedited 1129 1201 269 319 12 13
Exempt 271 309 6 7.5
Total 1631 1709 633 726
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Turnaround Times 2013 Turnaround Times: FB new studies – 33 days Expedited new studies – 12 days Exempt studies – 6 days
2014 Turnaround Times: FB new studies – 18 days Expedited new studies – 13 days* Exempt studies – 7.5 days** * # of Expedited new studies increased by 50
** # of Exempt new studies increased by 38
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RSRB Fee Schedule Change Jan. 1, 2014
Old Fee Schedule The RSRB only collects fees for the review of industry-sponsored research projects. A
description of review fees follows: Clinical Research Study (Effective June 1, 2010) Initial Review ………………………………..$1850.00 Continuing Review …………………………..$875.00 Changes to Research WITH Consent Modifications
(Initiated by the Sponsor..………………………………………$370.00
Changes to Research NO Consent Modifications (Initiated by the Sponsor)…………………………………........$275.00
Single Patient or expanded Access Protocols
(Effective June 1, 2010) Initial Review …………………………………$875.00 Continuing Review …………………………..$415.00
New Fee Schedule The RSRB only collects fees for the review of industry-sponsored research projects. A
description of review fees follows: Clinical Research Study (Effective June 1, 2010) Initial Review ………………………………..$2400.00 Continuing Review …………………………$1300.00 Changes to Research WITH Consent Modifications
(Initiated by the Sponsor..……………………………………...$420.00
Changes to Research NO Consent Modifications (Initiated by the Sponsor)…………………………………........$315.00
Single Patient or expanded Access Protocols
(Effective June 1, 2010) Initial Review …………………………………$875.00 Continuing Review……………………………$415.00
http://www.rochester.edu/ohsp/rsrb/policies/feeSchedule.html
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Policies & Guidelines
55 Policies 39 Guidelines Table of Contents – provides brief
explanation of purpose of each policy and guideline Starting 2 year re-review
http://www.rochester.edu/ohsp/policies/guidanceDocuments.html
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Policies & Guidelines Webpage
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Protocol Templates
Five types of protocol templates:
1. Biomedical 2. Non-Biomedical 3. Specimen & Record Review 4. Exemption Requests 5. Repositories http://www.rochester.edu/ohsp/rsrb/docTemplates/protocolTemplates.html
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ROSS Upgrades
Upgrade to the ROSS system platform Changes in application (upload buttons, grey
box instructions, etc.) Change to language in email notifications
from system Change to language and formatting of letters
from system (initial approval, continuing review, amendments, etc.)
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AAHRPP
What is it? UR’s HRPP
Summary of UR’s Status and Timeline Site Visit
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A A H R P P – What is it?
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Association for the Accreditation of Human Research Protection Programs
An accrediting organization Peer-driven, educational model Accreditation indicates the institution follows
rigorous standards for ethics, quality, and protections for human research subjects.
AAHRPP
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Accreditation every 5 years Institution must satisfy the elements
and standards under 3 primary “Domains” 1) Organization 2) Institutional Review Board 3) Researcher and Research Staff
AAHRPP
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UR’s HRPP
The UR’s HRPP includes not only the Office for Human Subject Protection (OHSP) and the Research Subjects Review Board (RSRB), but other units and individuals within the Institution and its affiliates
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UR’s HRPP
OHSP
SURG
Office of Counsel CRRPIT
CIAG ORPA
UR COI
Compliance
Ethics Committee
Investigators
URMC Privacy
Workgroup
CTSI Admin. Committee
Research Staff
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UR’s Status and Timeline
UR last accredited December 2010, therefore, UR’s accreditation expires December 2015 Must apply 1 year in advance Several steps, including a lengthy
application and a site visit Nearly 150 supporting documents Full Step 1 application nearly 1100 pages
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AAHRPP Timeline December 8, 2014 – UR submitted Step 1 December 9, 2014 – AAHRPP received Step 1 End Jan 2015 – OHSP receives feedback of
Step 1 Application (we respond as applicable) February 2015 – Step 1 finalized February 2015 – Step 2 submitted and site visit
scheduled May or June – Site visit ???? December 2015 – Council Meeting
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AAHRPP Site Visit
What is a site visit? “Peers” conduct on-site evaluation to
ensure practice is consistent with policy and procedures. Peers = HRPP Professionals from other
institutions/organizations IRB Professionals Compliance professionals Etc….
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AAHRPP Site Visit What does a site visit mean to me? Interview researchers in groups Interview research staff in groups Know the basics….. Who is your Institutional Official (IO)? What/Where are your resources? Website, HRPP Staff members
If you don’t know… DON’T make something up DO say where you would go or who you
would ask to find the answer
Quality Improvement
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Purpose of Quality Improvement: • To assure the rights and wellbeing of human subjects are
protected • To educate researchers about how to improve study
conduct • To assess research risk areas • To provide resources to the Research Community
Types of Reviews:
• Routine (Random) • Directed (For-Cause) • Requested
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QI – 2014 Statistics 122 completed 90 routine 18 for cause 14 other
(department requested, site evaluation, FDA audit preparation, sponsor audit preparation)
74%
15%
11%
ReviewsRoutine For Cause Other
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QI – 2014 Statistics 114 Ratings 4 Commendable 68 Acceptable 29 Acceptable with
follow up 13 Unacceptable
*Ratings are determined by the OHSP
QI team based upon the quality and severity of review findings, as defined by OHSP Policy 1001 Quality Improvement Program.
4%
60%
25%11%
RatingsCommendable Acceptable Acceptable with FU Unacceptable
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Most Common Findings include issues related to: Regulatory file documentation Informed consent Protocol adherence Subject eligibility Source documentation
Unacceptable – Why? involve major deficiencies that may affect subject safety (e.g., not obtaining consent or missing consent documentation, enrolling ineligible subjects, failing to comply with protocol-defined adverse event assessment
and/or safety monitoring, and errors related to investigational product assignment or distribution).
Study Documentation & Self Audit Tools Study documentation templates and self audit tools are available on the OHSP Quality Improvement (QI) website. Questions regarding the use of these templates/tools can be directed to the QI team.
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QI-2015 Plan Goal 80 routine reviews
85% Medical Center 15% Campus
Risk Based Approach
Primary Focus Phase 1 PI-initiated trials PIs new to research Student Projects Electronic health record Consult with study teams at study start up Secondary Focus UR PI-held INDs Sites not previously reviewed Vulnerable Populations No study coordinator Newly approved studies
Education & Training
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Training Framework
CITI Training
Orientation
Boot Camp
Core Training
Advanced Training
OHSP Education & Training Framework Website
Orientation • Introduce UR policies & required review processes
• Resources • Available through Blackboard
Boot Camp • Protocol Elements, Informed Consent, RSRB/WIRB Review Process, Post-Approval Considerations
• In-person quarterly; Blackboard version in future
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Core Training 1) Study Design 2) PI Oversight 3) Financial
Management 4) Study Operations 5) Recruitment &
Retention 6) Informed Consent
7) Investigational Products
8) Subject Safety 9) Essential
Documentation 10)Quality
Management & Non-Compliance
Goal: 1 module per month beginning in January
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Save the Date!
Core Training Module 1: Study Design Tuesday, January 27th, 12-1:30pm in K-307
Auditorium Core Training Module 2: PI Oversight Monday, February 9th, 12-1:30pm in Helen
Wood Hall Classroom 1W-502 If ≤ 1 yr experience, complete Boot Camp 1st Next session: Friday, January 16th, 8am-12pm
in Helen Wood Hall Classroom 1W-501
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What’s Missing? Exempt Research Data Management Multi-Site Study
Coordination Research Misconduct SOP Development Leadership HIPAA*
Advanced Training
OR Supplemental
Training (e.g., recorded seminar, video
for website)
32 Guideline for OHSP Education & Training Framework
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OHSP TRAINING Job Advancement
Requirements
Department Requirements
Faculty Dev Curriculum
Residency Training
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Other New “Stuff”
Study Team Training Checklists 2014 Q3 Newsletter
Quick Reference Guide Informed Consent Videos Policy 201 Education Program Guideline for OHSP Education & Training
Framework Guideline for Professional Certification
Reimbursement www.rochester.edu/ohsp
Special Thanks… To My Peeps
Questions?
It’s Quiz Show Time!
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Goals Review: Human Subject Protection Regulations Good Clinical Practice Guidelines OHSP Policies
Prepare for AAHRPP site visit Provide resources for future use Think about topics for future seminars
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If you want candy…
You have to play by the rules: Raise your hand rather than shouting out
the answer Speak loudly & clearly Don’t be shy!
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You are conducting focus groups with parents of middle school-aged children.
Parents are currently recruited through the Rochester City School District and focus groups are conducted on school grounds.
Enrollment has been slower than anticipated so you want to add 6 additional
suburban schools to the study. In preparing your RSRB amendment in
ROSS, what do you need to do?
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Adding Additional Study Sites 1) Complete the Amendment Form Don’t forget…
• Provide rationale for the change in section 2.2 • Carefully review your protocol, consent forms
and recruitment materials & upload revisions as appropriate
2) Revise the Amended Application Modify section 63.2 Upload Letters of Cooperation from each
additional site
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Part One: What are the 3 levels of PI
responsibilities/requirements outlined in OHSP Policy 901 Investigator
Responsibilities?
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OHSP Policy 901: Investigator Responsibilities
FDA Regulated (1+2+3+4)
Non-FDA Regulated (1+2+3)
Exempt (1+2)
All Principal Investigators (1)
OHSP Policy 901 Investigator Responsibilities & Responsibility Summary Sheet
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Part Two: You are conducting a study that will enroll patients post-cancer treatment. Subjects
will be randomized into 1 of 4 interventions. Each group will 1 of 2 different levels of counseling, either with or without a pet therapy component. In addition to the
assigned intervention subjects will complete questionnaires and have 3 small blood samples drawn over the course of 12
months. Which level of PI responsibility will this study likely be assigned?
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OHSP Policy 901: Investigator Responsibilities
FDA Regulated (1+2+3+4)
Non-FDA Regulated (1+2+3)
Exempt (1+2)
All Principal Investigators (1)
OHSP Policy 901 Investigator Responsibilities & Responsibility Summary Sheet
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You are conducting a NIH-funded study that will enroll subjects that have been prescribed an FDA-approved medication for the treatment of
high cholesterol as part of their routine care (e.g., Crestor or Zocor). Study participation will involve EKG, EEG, exercise testing, blood
sampling (~30ml), survey completion and the collection of information from the medical record every 6 months. The study has been actively
enrolling subjects for the past 2 years and you’ve just received a notification that the study will undergo a routine QI review by OHSP.
Under which of the following regulations and/or guidelines will the study be reviewed:
I. RSRB approved protocol II. Good Clinical Practice III. UR Policy IV.UR’s FWA
A) I & III only C) I, II & III B) I, III & IV D) I, II, III & IV
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You are conducting a NIH-funded study that will enroll subjects that have been prescribed an FDA-approved medication for the treatment of
high cholesterol as part of their routine care (e.g., Crestor or Zocor). Study participation will involve EKG, EEG, exercise testing, blood
sampling (~30ml), survey completion and the collection of information from the medical record every 6 months. The study has been actively
enrolling subjects for the past 2 years and you’ve just received a notification that the study will undergo a routine QI review by OHSP.
Under which of the following regulations and/or guidelines will the study be reviewed:
I. RSRB approved protocol II. Good Clinical Practice III. UR Policy IV.UR’s FWA
A) I & III only C) I, II & III B) I, III & IV D) I, II, III & IV
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OHSP Policy 1001 Quality Improvement Program
Notification Memo Final Report
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What does this mean and how does it apply to research…
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Not taking time up front to thoroughly & appropriately plan all aspects of the study, can lead to: low enrollment, high dropout rates, missing study documentation, poor
study data, protocol deviations, non-compliance, increased subject risk…
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Question: Who is the University of Rochester’s Institutional Official (IO) and the person who is ultimately responsible for the UR’s HRPP?
a) Karl Kieburtz b) Kelley O’Donoghue c) Rob Clark d) Tiffany Gommel
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Who is the University of Rochester’s Institutional Official (IO) and the person who is ultimately responsible for the UR’s HRPP? Answer: c) Rob Clark The Institutional Official, delegated by the
President of the institution, oversees the implementation and maintenance of the HRPP. Responsibilities for daily administration and oversight of human subject research is delegated to the Office for Human Subject Protection (OHSP). OHSP Policy 103 Organizational Structure of the Human Research Protection Program
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Question: How do you learn about new releases of policies and/or guidelines from the Office for Human Subject Protection (OHSP)? Open Response……
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How do you learn about new releases of policies and/or guidelines from the Office for Human Subject Protection (OHSP)? Answer:
OHSP Newsletter Listserv email OHSP Educational Seminars
OHSP Policies & Guidelines
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Question: Who do you contact if you have any questions or concerns about the HRPP or the RSRB?
a) An RSRB Specialist b) Kelley O’Donoghue c) Rob Clark d) Tiffany Gommel e) The RSRB main office line
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Who do you contact if you have any questions or concerns about the HRPP or the IRB?
a) An RSRB Specialist b) Kelley O’Donoghue c) Rob Clark d) Tiffany Gommel e) The RSRB main office line
Answer: All of the above! Anyone in OHSP, RSRB or the Institutional Official may be contacted with any questions or concerns. OHSP Staff Directory
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Question: What is the RSRB’s training requirement in order to conduct research?
a) Research Boot Camp b) Human Subjects Training (e.g., CITI) c) RSRB On-line Submission System
(ROSS) Training d) Professional Certification (e.g., CCRC)
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What is the RSRB’s training requirement in order to conduct research?
Answer: b) Human Subjects Training (e.g., CITI) While other certifications and training may be completed, the OHSP requires certification in human subjects education in order to be involved in the conduct of research activities. OHSP Policy 201 Education Program OHSP Guideline for Education & Training Framework OHSP Research Education and Training website
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Question: How often must researchers re-certify human subjects training?
a) Annually b) Every 3 Years c) Every 5 Years d) Only initial certification is required
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How often must researchers re-certify human subjects training?
Answer: b) Every 3 Years OHSP requires that individuals conducting research in the UR HRPP are responsible for completing and maintaining the required basic human subjects training certification every 3 years. OHSP Policy 201 Education Program OHSP Guideline for Education & Training Framework OHSP Research Education and Training website
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Question: Who is responsible for conducting scientific review and ensuring adequate staff qualifications and resources?
a) Investigator (or designee) b) Sponsor c) RSRB d) Department Chair (or designee)
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Who is responsible for conducting scientific review and ensuring adequate staff qualifications and resources?
Answer: d) Department Chair (or designee)
The Investigator’s department Chair (or qualified designee) is responsible for ensuring the scientific merit of the protocol, conducting a risk assessment, and assessing investigator qualifications and available resources for the conduct of the study prior to RSRB review. OHSP Policy Scientific Review for Human Subjects Research
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Question: The RSRB reviews Data and Safety Monitoring Reports at the time of continuing review. True or False
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The RSRB reviews Data and Safety Monitoring Reports at the time of continuing review? Answer: True
Researchers are responsible for including DSMB reports to the RSRB as requested in the ROSS application and according to policy and guidelines noted below.
OHSP Policy 506 Data & Safety Monitoring OHSP Guideline for Reporting Research Events
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Question: What types of research events need to be reported to the RSRB? Open Response……
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What types of research events need to be reported to the RSRB? Answer: Internal event External event Adverse event Subject complaint Unanticipated problems Non-compliance New information
Report timing depends on type of event, risk level, etc. Refer to the policy and guideline for details on when appropriate to report. OHSP Policy 801 Reporting Research Events OHSP Guideline for Reporting Research Events
Questions?
