Annual Updates from the Office for Human Subject Protection · 2016-02-02 · Annual Updates from the Office for Human Subject Protection Jennifer Dolan, Tiffany Gommel, Kelly Unsworth

Annual Updates from the Office for Human Subject Protection

Annual Updates from the Office for Human Subject Protection

Jennifer Dolan, Tiffany Gommel, Kelly Unsworth & Kathleen Wessman

January 26, 2016

Jennifer Dolan, Tiffany Gommel, Kelly Unsworth & Kathleen Wessman

January 26, 2016

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Research Subjects Review Board (RSRB)

Research Subjects Review Board (RSRB)

RSRB Metrics

AAHRPP Reaccreditation

What’s to come in 2016

RSRB Metrics

AAHRPP Reaccreditation

What’s to come in 2016

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Metrics - # of Active StudiesMetrics - # of Active Studies

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Metrics - # of New StudiesMetrics - # of New Studies

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Metrics - Turnaround Times in Calendar Days

Metrics - Turnaround Times in Calendar Days

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AAHRPP ReaccreditationAAHRPP Reaccreditation

Site visit – 9/30 – 10/2/2015 Results = 1 observation Documentation of UPIRTSO and

possible serious or continuing non-compliance

Site visit – 9/30 – 10/2/2015 Results = 1 observation Documentation of UPIRTSO and

possible serious or continuing non-compliance

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AAHRPP ReaccreditationAAHRPP Reaccreditation Policies and procedures state the RSRB review

reportable events assesses whether it is a UPIRTSO and/or possibly serious or continuing non-compliance.

In practice, RSRB did not always document the determination of whether the event was noncompliance and, if so, whether it was serious or continuing.

In practice, UPIRTSOs were not always also assessed to determine and document whether the report represented noncompliance and, if so, whether it was serious or continuing.

Policies and procedures state the RSRB review reportable events assesses whether it is a UPIRTSO and/or possibly serious or continuing non-compliance.

In practice, RSRB did not always document the determination of whether the event was noncompliance and, if so, whether it was serious or continuing.

In practice, UPIRTSOs were not always also assessed to determine and document whether the report represented noncompliance and, if so, whether it was serious or continuing.

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AAHRPP ReaccreditationAAHRPP Reaccreditation

Update minutes template to document identification of non-compliance and determination of possibly serious or continuing

Quality Improvement Reports Continuing Reviews Reportable Events Amendments

Updated Approval Checklist in ROSS for CR and Amendment to document.

Update minutes template to document identification of non-compliance and determination of possibly serious or continuing

Quality Improvement Reports Continuing Reviews Reportable Events Amendments

Updated Approval Checklist in ROSS for CR and Amendment to document.

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Non-ComplianceNon-Compliance“Failure to follow federal, state, or local

regulations or laws governing the protection of human subjects in research, institutional policies related to human subject research, or the requirements or determinations of the

RSRB/IRB of record with respect to the conduct of the research as approved.”

(OHSP Policy 802, 2014)

“Failure to follow federal, state, or local regulations or laws governing the protection of human subjects in research, institutional policies related to human subject research, or the requirements or determinations of the

RSRB/IRB of record with respect to the conduct of the research as approved.”


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ExamplesExamples Over-enrollment of subjects Consent issues (no consent, no signature, wrong

version) Not following approved recruitment procedures Enrolling ineligible subjects Protocol deviations (e.g., visits conducted out of

window) Not performing protocol-defined safety assessments Lapses in study approval Issue with drug dosing Mis-randomization

Over-enrollment of subjects Consent issues (no consent, no signature, wrong

version) Not following approved recruitment procedures Enrolling ineligible subjects Protocol deviations (e.g., visits conducted out of

window) Not performing protocol-defined safety assessments Lapses in study approval Issue with drug dosing Mis-randomization

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Serious Non-ComplianceSerious Non-Compliance Non-compliance that results in an increased risk to

subjects or others. Non-compliance may also be deemed serious when it involves fraud and/or scientific misconduct, even in research posing minimal risk to subjects

Possible examples:- Conducting research without RSRB approval or revising the

protocol without RSRB approval- Enrolling subjects who were not eligible- Not performing safety measures- Failure to obtain consent from a research subject


Non-compliance that results in an increased risk to subjects or others. Non-compliance may also be deemed serious when it involves fraud and/or scientific misconduct, even in research posing minimal risk to subjects

Possible examples:- Conducting research without RSRB approval or revising the

protocol without RSRB approval- Enrolling subjects who were not eligible- Not performing safety measures- Failure to obtain consent from a research subject


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Continuing Non-ComplianceContinuing Non-Compliance A pattern of non-compliance that continues despite

identification by the RSRB, notice to the investigator, or prior submission of a corrective action plan. This pattern may or may not result in increased risk to subjects.

Example:1) Continuing issues with appropriately documenting consent

and/or renewing RSRB approvals in a timely manner2) Board reviews incident and approves a corrective/

preventative action plan3) The PI continues to fail to document consent appropriately

and/or renew RSRB applications prior to expiration4) Incident returns to the board for review and determination

A pattern of non-compliance that continues despite identification by the RSRB, notice to the investigator, or prior submission of a corrective action plan. This pattern may or may not result in increased risk to subjects.

Example:1) Continuing issues with appropriately documenting consent

and/or renewing RSRB approvals in a timely manner2) Board reviews incident and approves a corrective/

preventative action plan3) The PI continues to fail to document consent appropriately

and/or renew RSRB applications prior to expiration4) Incident returns to the board for review and determination


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IRB Reporting RequirementsIRB Reporting Requirements

Determinations of serious or continuing non-compliance, UPIRTSO (or suspension/ termination) requirereporting to: Institutional officials – IO (Senior VP for

Research), Dept Chair, LegalRegulatory authorities – OHSP, FDAStudy sponsors

(OHSP Policy 403; OHSP Policy 801)

Determinations of serious or continuing non-compliance, UPIRTSO (or suspension/ termination) requirereporting to: Institutional officials – IO (Senior VP for

Research), Dept Chair, LegalRegulatory authorities – OHSP, FDAStudy sponsors

(OHSP Policy 403; OHSP Policy 801)

Coming in 2016Coming in 2016

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Policies & GuidelinesPolicies & Guidelines

Starting 2 year re-reviewhttp://www.rochester.edu/ohsp/policies/guidanceDocuments.html

Consent form revisions to templatesCompensation for Injury languagehttp://www.rochester.edu/ohsp/rsrb/docTemplates/consentFormTemplates.html

Starting 2 year re-reviewhttp://www.rochester.edu/ohsp/policies/guidanceDocuments.html

Consent form revisions to templatesCompensation for Injury languagehttp://www.rochester.edu/ohsp/rsrb/docTemplates/consentFormTemplates.html

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ROSS UpgradeROSS Upgrade

Moved to new server – 12/11 – 12/14 Upgrade to version 6.0 Review of application/forms (new,

amend, CR, RE) to streamline questions and workflow

Moved to new server – 12/11 – 12/14 Upgrade to version 6.0 Review of application/forms (new,

amend, CR, RE) to streamline questions and workflow

Quality ImprovementQuality Improvement

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Purpose of Quality Improvement: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

• 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)• Site-Requested

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QI – 2015 StatisticsQI – 2015 Statistics 120 completed 84 Routine 20 Directed 16 Other

7 department/site requested 1 IRB authorization site evaluation 8 FDA audit preparation

120 completed 84 Routine 20 Directed 16 Other

7 department/site requested 1 IRB authorization site evaluation 8 FDA audit preparation

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QI – 2015 StatisticsQI – 2015 Statistics 104 Ratings 3 Commendable 58 Acceptable 25 Acceptable with

follow up 15 Unacceptable 3 Not yet rated

*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.

104 Ratings 3 Commendable 58 Acceptable 25 Acceptable with

follow up 15 Unacceptable 3 Not yet rated

*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.

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Most Common Findings include issues related to: Regulatory file documentation Informed consent Protocol adherence Subject eligibility Source documentation

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 ToolsStudy 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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Year to Year ComparisonYear to Year Comparison20142014 Reviews - 12290 Routine18 Directed14 Other

Ratings 4 Commendable72 Acceptable29 Acceptable with FU13 Unacceptable 4 not rated

Reviews - 12290 Routine18 Directed14 Other

Ratings 4 Commendable72 Acceptable29 Acceptable with FU13 Unacceptable 4 not rated

20152015 Reviews – 12084 Routine20 Directed16 Other

Ratings – 104 (3 are not yet rated)

3 Commendable58 Acceptable25 Acceptable with FU15 Unacceptable16 Summaries (no rating expected)

Reviews – 12084 Routine20 Directed16 Other

Ratings – 104 (3 are not yet rated)

3 Commendable58 Acceptable25 Acceptable with FU15 Unacceptable16 Summaries (no rating expected)

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Feedback SurveyFeedback SurveyReviews Study Start Up

# Surveys Completed 191 13The recommendations were helpful, constructive, relevant, and achievable.

92% 100%

The process was helpful in identifying and improving study-related procedures/processes.

94% 100%

Overall experience with OHSP-QI

96% 100%

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QI-2016 PlanQI-2016 Plan

Goal20 Study Start-Up Consults

68 routine reviews*

*85% Medical Center +15% Campus

Goal20 Study Start-Up Consults

68 routine reviews*

*85% Medical Center +15% Campus

Primary Focus – Risk-Based Re-review CAPA with DSMP/AE

issues Phase 1 PIs new to research Student Projects Sites not previously reviewed

Secondary Focus UR PI-held INDs Vulnerable Populations No study coordinator Newly approved studies

Primary Focus – Risk-Based Re-review CAPA with DSMP/AE

issues Phase 1 PIs new to research Student Projects Sites not previously reviewed

Secondary Focus UR PI-held INDs Vulnerable Populations No study coordinator Newly approved studies

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Study Start Up (SSU) ProgramStudy Start Up (SSU) Program

The SSU program: was launched in July is a direct result of Feedback

Survey comments is conducted after IRB approval and before subjects are

enrolled Goal: To assist Investigators/study staff in achieving

compliance with research regulations, policies, and guidelines applicable to their specific study and to further protect subjects who participate in research.

The SSU program: was launched in July is a direct result of Feedback

Survey comments is conducted after IRB approval and before subjects are

enrolled Goal: To assist Investigators/study staff in achieving

compliance with research regulations, policies, and guidelines applicable to their specific study and to further protect subjects who participate in research.

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Common SSU ObservationsCommon SSU Observations Need for: Assessment of each signed consent for accuracy and

completeness Eligibility documentation Data Safety Monitoring, Adverse Event reporting, and

protocol deviation documentation Policy 901 – Investigator Responsibilities Discuss OHSP Education resources; provide handouts,

SSU folder Email OHSP Quality Improvement to request a Study

Start Up Consult

Need for: Assessment of each signed consent for accuracy and

completeness Eligibility documentation Data Safety Monitoring, Adverse Event reporting, and

protocol deviation documentation Policy 901 – Investigator Responsibilities Discuss OHSP Education resources; provide handouts,

SSU folder Email OHSP Quality Improvement to request a Study

Start Up Consult

Research Education & Training

Research Education & Training

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Human Subjects Training (i.e., CITI Training)

Human Subjects Training (i.e., CITI Training)

Training Modules Updated August 2015 Training Modules Updated August 2015- Eliminated repetitive and/or

unnecessary modules• Initial: 18 (GTMR); 16 (MR)• Refresher: 10/11/13 (GTMR); 9/10

(MR)

- Reviewed module content• e.g.) Informed Consent Biomedical

vs. Informed Consent SBR

- Eliminated repetitive and/or unnecessary modules• Initial: 18 (GTMR); 16 (MR)• Refresher: 10/11/13 (GTMR); 9/10

(MR)

- Reviewed module content• e.g.) Informed Consent Biomedical

vs. Informed Consent SBR

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The End of an EraThe End of an Era

Effective September 14, 2016, “HSPP” and “EPRP” certifications no

longer exist!

Effective September 14, 2016, “HSPP” and “EPRP” certifications no

longer exist!

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Training FrameworkTraining Framework

Orientation

Boot Camp

Core Training

Advanced Training

http://www.rochester.edu/ohsp/education/certification/educationTrainingMaterials.html

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Training FrameworkTraining Framework

Orientation (2015 N=69)Available online via Blackboard since 11/2014Substantial changes in design (not content)

implemented 11/2015 2016 Goal: Migrate to MyPath

Boot Camp (2015 N=94)Continued to run in-person sessions quarterly2016 Goal: Implement online version in MyPath;

continue to offer in-person

Orientation (2015 N=69)Available online via Blackboard since 11/2014Substantial changes in design (not content)

implemented 11/2015 2016 Goal: Migrate to MyPath

Boot Camp (2015 N=94)Continued to run in-person sessions quarterly2016 Goal: Implement online version in MyPath;

continue to offer in-person

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Training FrameworkTraining FrameworkCORE TRAININGModule N

1 – Study Design 152 – PI Oversight 83 – Financial Management N/A4 – Study Operations 95 – Recruitment & Retention 176 – Informed Consent 187 – Investigational Products 228 – Subject Safety 269 – Essential Documentation 4010 – Quality Management & Non-Compliance 28

Co-Presenters!!

2016 Goal: Implement online version; continue to offer in-person

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Training FrameworkTraining FrameworkCORE TRAININGModule N

1 – Study Design 152 – PI Oversight 83 – Financial Management N/A4 – Study Operations 95 – Recruitment & Retention 176 – Informed Consent 187 – Investigational Products 228 – Subject Safety 269 – Essential Documentation 4010 – Quality Management & Non-Compliance 28

Co-Presenters!!

2016 Goal: Implement online version; continue to offer in-person

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Core Training Module 3Core Training Module 3

Core Training Outline

35Guideline for OHSP Education & Training FrameworkGuideline for OHSP Education & Training Framework

Certificate of Course Completion = Successful competency check with

completion of ALL modules

** Email Kelly when you’re ready!**

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What’s Missing?What’s Missing? Data Management Exempt Research Leadership Training Coordinating Ctr Studies Regulatory Submissions

(advanced) Research Misconduct SOP Development Quality Mgmt (advanced)

Data Management Exempt Research Leadership Training Coordinating Ctr Studies Regulatory Submissions

(advanced) Research Misconduct SOP Development Quality Mgmt (advanced)

Advanced Training (12/2016)

ORSupplemental

Training (e.g., recorded

seminar, video for website)

Advanced Training (12/2016)

ORSupplemental

Training (e.g., recorded

seminar, video for website)

37Guideline for OHSP Education & Training FrameworkGuideline for OHSP Education & Training Framework

$ Except CITI Training, completion requirements and their corresponding time frames are recommendations only. Department chairs, Center Directors, Administrators and other UR Senior Leadership may institute course completion requirements that override OHSP recommendations as they see fit.

Just one more training framework reminder…

38Study Team Training Checklists & Resource Reference List

Call/E-mail Kelly Unsworth

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November 5th – December 7th

N=65 Basic evaluation of: Basic Human Subjects Training (CITI) E-mail Distribution List Seminar Series Education & Training Framework Professional Research Certification

Overall…results are positive = no major changes

November 5th – December 7th

N=65 Basic evaluation of: Basic Human Subjects Training (CITI) E-mail Distribution List Seminar Series Education & Training Framework Professional Research Certification

Overall…results are positive = no major changes

Education & Training SurveyEducation & Training Survey

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Survey ResultsSurvey Results

Basic Human Subjects Training

…No Changes…

Basic Human Subjects Training

…No Changes…

25.9%

55.2%

6.9%

12.1%

0.0%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

Overall, I'm satisfied with using CITI to complete/maintain my human subjects training.

25.9%

55.2%

6.9%

12.1%

0.0%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

Overall, I'm satisfied with using CITI to complete/maintain my human subjects training.

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Survey ResultsSurvey Results

E-mail Distribution List E-mail Distribution List Seminar Series Seminar Series

87.7%

0.0%

1.8%

5.3%

0.0% 20.0% 40.0% 60.0% 80.0% 100.0%

I think the number of e‐mails OHSPsends out is reasonable.

I think OHSP sends out too many e‐mails.

I would like to see OHSP e‐mails sentout on a more regular basis.

I would like to see OHSP e‐mails sentout on a less regular basis.

Which of the following statements most accurately describes your attitude regarding the frequency in

which you receive e‐mails from OHSP? (Select all that apply)

34.1%

65.9%

0.0%

0.0%

0.0%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0%

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

Overall, I'm satisfied with the seminar series.

…No Changes…

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Survey ResultsSurvey Results Education & Training Framework Education & Training Framework

52.0%

48.0%

0.0%

0.0%

0.0%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

Overall, I'm satisfied with the Training Framework.

48.0%

52.0%

0.0%

0.0%

0.0%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

Overall, I'm able to conduct higher quality, ethical research as a resuult of this training.

PHEW!

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Additional Take Homes(Education & Training Framework)


Format Boot Camp: Continue in-person

sessions after MyPath conversion

Core: Combo (2017) Future: In-person

sessions continued after MyPath conversion

Format Boot Camp: Continue in-person

sessions after MyPath conversion

Core: Combo (2017) Future: In-person

sessions continued after MyPath conversion

24.0%

44.0%

28.0%

4.0%

0.0%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0%

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

I prefer in‐person training sessions to online training.

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Length of Sessions Split here… No changes (for now) Instructor availability Continuity of

attendance? Decrease in

attendance?

Length of Sessions Split here… No changes (for now) Instructor availability Continuity of

attendance? Decrease in

attendance?

4.0%

32.0%

32.0%

32.0%

0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0%

Strongly Agree

Agree

Neutral

Disagree

I prefer longer training sessions less frequently to shorter training sessions

more frequently.

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Timing of Sessions Increase variability More morning, late

afternoon

Timing of Sessions Increase variability More morning, late

afternoon

12.0%

48.0%

28.0%

12.0%

0.0%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

I prefer training held first thing in the morning.

0.0%

28.0%

48.0%

24.0%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

Strongly Agree

Agree

Neutral

Disagree

I prefer training held during the mid‐afternoon.

12.0%

48.0%

28.0%

12.0%

0.0%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

I prefer training held late in the afternoon.

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Training Requirements…Still no changes (on our end)…

Training Requirements…Still no changes (on our end)…

42.9%

51.4%

5.7%

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

Yes

No

I'm not sure

Have training requirements, utilizing components of the Training Framework, been set forth for your

specific role by your Department, Principal Investigator or immediate Supervisor?

8.0%

20.8%

29.2%

37.5%

4.2%

0.0% 10.0% 20.0% 30.0% 40.0%

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

I think trainees should be required to complete components of the Training Framework in the

order in which they are presented.

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Survey CommentsSurvey Comments Continuing Medical Education CreditsStill no changes

- Added expense = no more free training- Current (Free) CME Opportunities:

OHSP & CTSI Seminar Series SCORE ½ Day (June) URMC Scientific Events Calendar ACRP Quarterly CE Activity (also local mtgs w/ fee) SoCRA Events – Fall, Winter, Spring (w/ travel fees) Quorum IRB

Side Note: Issues with CME Transcript? Contact Kelly Unsworth and/or CEL Office

Continuing Medical Education CreditsStill no changes

- Added expense = no more free training- Current (Free) CME Opportunities:

OHSP & CTSI Seminar Series SCORE ½ Day (June) URMC Scientific Events Calendar ACRP Quarterly CE Activity (also local mtgs w/ fee) SoCRA Events – Fall, Winter, Spring (w/ travel fees) Quorum IRB

Side Note: Issues with CME Transcript? Contact Kelly Unsworth and/or CEL Office

48

MyPathMyPath CITI?? Education & Training FrameworkOrientation

- All online (in MyPath); Goal = February 2016

Boot Camp- Documentation of attendance 2016+- Goal for MyPath version = ?? 2016

Core Training- Documentation of attendance 2016+- Goal for MyPath (selected modules) = 2017

CITI?? Education & Training FrameworkOrientation

- All online (in MyPath); Goal = February 2016

Boot Camp- Documentation of attendance 2016+- Goal for MyPath version = ?? 2016

Core Training- Documentation of attendance 2016+- Goal for MyPath (selected modules) = 2017

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Upcoming Training Opportunities

Boot Camp – April 29th, 12-4pm Core Training2: PI Oversight

- February 22nd, 12-1:30pm4: Study Operations

- March 30th, 2-4:30pm5: Recruitment & Retention

- April 25th, 12-1:30pm

Upcoming Training Opportunities

Boot Camp – April 29th, 12-4pm Core Training2: PI Oversight

- February 22nd, 12-1:30pm4: Study Operations

- March 30th, 2-4:30pm5: Recruitment & Retention

- April 25th, 12-1:30pm