Syracuse VAMC HRPP OfficeSyracuse VAMC HRPP OfficeServing Bath, Canandaigua & Serving Bath, Canandaigua & Syracuse VA Medical CentersSyracuse VA Medical Centers

VERSION: August 20141

IntroductionWelcome to human subject research at the Syracuse VAMC! You are

taking a first step to begin health-related research that will benefit all of our Veteran patients.

This presentation is a training guide with helpful information for new investigators and staff.

HRPP documents referenced in this training as well as additional education can be found:R&D Website: http://www.visn2.va.gov/apps/visn2shared/research/syr/syrforms.cfmSyracuse Research Service SharePoint (VA Access Only): https://vaww.visn2.portal.va.gov/sites/syr/research/default.aspx

Please fill out the HRPP Certificate, print, sign and date when you complete this training and submit it to the IRB Office for course credit.

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Multiple Governing Bodies over research

VA researchers and staff must follow all rules:International rules (ICH-GCP-E6) for Good Clinical Practice

(GCP),

U.S Federal regulations (Common Law, Department of Health & Human Services/DHHS),

FDA rules for foods, cosmetics, drugs and device research,

VA Central Office R&D (ORD) rules and regulations,

Local Syracuse VAMC R&D rules.

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R&D SOP Policies & Procedures

We understand there is a tremendous amount of information within VHA Handbooks and Local Policies and Procedures.

Please familiarize yourself with where to look for information.

R&D Website: http://www.visn2.va.gov/apps/visn2shared/research/syr/syrforms.cfmorSyracuse Research Service SharePoint (VA Access Only): https://vaww.visn2.portal.va.gov/sites/syr/research/default.aspxorContact the HRPP Office

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Mandatory Human Subjects Protection Training (Required Trainings)

VA requires annual training for all VA researchers and their staff involved in VA-approved research.NOTE: individuals with WOC (Without Compensation) appointments are VA employees.

1) CITI and VA Human Subject Protection and Good Clinical Practice: Initial Training. You must complete the 5 required GCP modules, plus your choice of 8 elective modules from a list of 18.Refresher Training. You must complete the 6 required GCP refresher modules, plus your choice of 8 elective modules from a list of 32. The refresher training is required every two years after the initial training.

2) HRPP Training: This PowerPoint course is only required once for staff who have contact directly with patients or personally identifiable data, all committee members and scientific reviewers.

PIs will not receive final protocol approval notification until training is complete for them and any personnel listed as working on the protocol. It is the PI’s responsibility to ensure that staff working on their research protocol(s) remain compliant with required research training.

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New Research Protocol Submissions

The current IRB Submission Forms can be found at

1) R&D Website: http://www.visn2.va.gov/apps/visn2shared/research/syr/syrforms.cfmor2) Syracuse Research Service SharePoint (VA Access Only): https://vaww.visn2.portal.va.gov/sites/syr/research/default.aspx

HINT: Use the checklist for submission to ensure you have used all of the required forms. You may not need the entire list of forms available online. The items used are dependent on the research you are planning. You will need to ensure all of the required signatures are obtained prior to submission. HRPP Staff will obtain the ACOS R&D Signatures needed on the Scope of Work Documents.

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Saving forms for re-use may be a good time management strategy; however IRB Forms are updated regularly based on changes in regulations.

You need to ensure the form you are using is the current version of the document in order to meet all regulatory requirements, otherwise unnecessary delays may occur with reviewing your protocol.

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VA Investigator

Any individual who conducts research approved by a VA Research & Development Committee includingVA appointment on VA timeFull & part-time VA employeesWithout compensation (WOC) VA employeesAppointed or detailed to VA under the Intergovernmental

Personnel Act (IPA)

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Investigator ResponsibilitiesUpholding professional & ethical standards & practices

Adhering to all applicable requirements for conduct of research & the protection of human subjects VAOther Federal requirementsSyracuse Research and Development’s Standard Operating

Procedures (SOPs),

Responsibilities may be defined in the protocol or IRB application

Some of responsibilities may be delegated to an investigator working under the PI, however the PI is ultimately responsible for all study conduct

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Investigator’s Responsibilities: Assessing Impaired Decision Making Capacity (IDMC)

Before proceeding with the Informed Consent Process, the Investigator, or their designee, must complete the Impaired Decision Making Capacity Form (IDMC) with potential subjects. A key factor in participants' decision making is their appreciation of how the risks, benefits, and alternatives to participation in the study apply to them personally. The investigator must retain the IDMC in the Investigator files. It is not intended for issuance to the subject or submission to the IRB. For more information, (please see R&D SOP 151-06: Impaired Decision Making Capacity (IDMC) under Policy and Procedure on the R&D website.)

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Investigator’s Responsibilities: Performing Subject Outreach

Investigators are required to make available to the potential subjects the informational brochure, “Volunteering in Research – Here Are Some Things You Need To Know” http://www.research.va.gov/programs/pride/veterans/tri-fold.pdf

Contact the HRPP Office for color copies of this tri-fold document.Documentation that this handout was given to subject must be

included in the CPRS Research Study Initiation Note (RSIN)

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Investigator’s Responsibilities: HIPAA

Investigators are responsible for obtaining HIPAA authorization for the use & disclosure of the subject’s Protected Health Information (PHI), or obtaining a waiver of HIPAA authorization

Your final approved HIPAA (Form 10-0493, Version May 2014 or later) document will include an IRB stamp of approval once the PO completes the required reviews. Do not use a HIPAA document which does not include the stamp approval.

HRPP Administrative Staff work with the PO to obtain approval of your HIPAA documents submitted for IRB review.

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Investigator’s Responsibilities: Informed Consent

Obtaining & documenting informed consent prospectively Investigator cannot screen, interact, or intervene with a subject until

after meeting the IRB-approved informed consent requirements (see Consent Form Template 10-1086)

If you plan to collect picture, video, or voice recording during your Research Project or Study, please complete VA Form 10-3203 in addition to Consent Form 10-1086

Exceptions IRB approves a waiver of informed consent IRB approves a waiver of documentation of informed consent form

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True Informed Consent encompasses BOTH the “Process” and the “Form”True Informed Consent encompasses BOTH the “Process” and the “Form”

Investigator’s Responsibilities: Informed Consent Continued…

The ICF and HIPAA original documents must be placed in the subject binder and a copy:

1. copy to subject – PRIOR to subject leaving clinic area even if PI has not signed the document. The subject needs to have in their possession what they signed/agreed to.

2. copy to medical records for scanning into CPRS within ONE WEEK (use Internal Clinical Records for Scanning Form).

3. copy to Research Compliance Officer within ONE WEEK of subject enrollment.

4. copy to Pharmacy, if study drug involved, before study drug released to subject. Also provide copy of 10-9012 with consent to research pharmacy.

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Investigator Responsibilities: Informed Consent Continued…

GO! GO! Submit Informed Consent copies to the HRPP Office AND for CPRS scanning WITHIN ONE WEEK of enrollment.

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STOP!STOP! DO NOT enroll more participants than the study protocol is approved for. IRB Approval of Total Recruitment Number MUST be granted beforehand. Subjects who sign consent are considered “enrolled” even if they do not qualify for study inclusion immediately after consent. These subjects will count as part of your total recruitment numbers.

CAUTION! CAUTION! CPRS Notes should be used for ALL participants enrolled on your study, UNLESS otherwise waived by the IRB.

Significant differences between DHHS, FDA, and VA ICF regulationsResearch in the VA always follows the most rigorous application of a regulation

Regulation DHHS Title 45 CFR part 46

FDA Title 21 CFR 50 & 56 Sponsors 312 & 812

Syracuse VAVHA Handbook 1200.5 IRB SOP 151-02

Emergency exception of ICF Not allowed Allowed Not allowed

ICF includes mandatory inspection of subject’s medical records

Not imposed in ICF Explicitly required in ICF Included in VA template 10-1086

ICF signatures and dates Requires signature but not date

Both required Both required as well as time.Also PI signature required within 24 hours

ICF and Record Retention after study completion

At least 3 years At least 5 years All investigator records must be maintained indefinitely by investigator or service in which the investigator works until scheduled by NARA.

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Investigator Responsibilities: Reporting Deviations, Complaints, Problems, & SAEs

Reporting deviations from the protocol & subject complaints to the IRB in a time frame specified byR&D SOP 151-17ORO

Reporting all unanticipated problems involving risks to subjects or others, & all unanticipated internal (i.e., local) SAEs, whether related or unrelated to the research, in accordance with local SOPs & VHA Handbook 1058.01*

*See ORO website: http://www1.va.gov/oro/17

Investigator Responsibilities: Obtaining IRB Approval for All Changes (Amendments)

Obtaining IRB approval for all changes to the research prior to implementing the changes

Amendments or modifications to the protocolChanges to the IRB-approved informed consent form

ONE EXCEPTIONONE EXCEPTIONEliminating apparent immediate hazard to the subjectMUST promptly report these changes to the IRB!

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Research Data Security

Recently there has been a number of identified issues regarding research data security

Please work with the facility Information Security Officer to obtain their approval on your data security plan (Use Data Security Checklist for PIs Form) PRIOR to IRB submission

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Scopes of Practice for Researchers and Staff

ALL STAFF MUST HAVE PI ADDENDUM (1) or SCOPE OF WORK MEMO (2)As applicable to their research role(HRPP Staff will obtain ACOS R&D signature on these documents for you)

(1) SYRACUSE VAMC ADDENDUM TO CLINICAL FUNCTIONAL STATEMENT FOR PI’SAll Syracuse VAMC Principal Investigators are required to have an addendum in their Clinical Functional Statements identifying research duties/activities if the research activities are in line with their approved clinical privileges. Syracuse PIs submit this Syracuse VAMC Addendum to Clinical Functional Statement in lieu of the scope of work document.(Canandaigua PIs contact Mary Adams, CAN RCO for additional scope of work guidance)

(2) SCOPE OF WORK MEMOS FROM COLLABORATORS/COORDINATORS/ALL STAFF

Submit one form from each: Sub-I, NP, all Coordinators and other staff involved with the conduct of the study.(Canandaigua staff contact Mary Adams, CAN RCO for additional scope of work guidance)

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Investigator’s Responsibilities: Project Regulatory Clock The IRB can issue approval for your research project for up to 12-months.

Do NOT start research activities prior to your receipt of the IRB approval letters. Continuing Review:

Investigators must provide the IRB sufficient time for reviewing & approving the study before the IRB approval expires.

The scheduled IRB Meeting date for continuing review is found on your IRB approval letters. This is generally the IRB meeting within 30-days prior to the project expiration.

IRB approval automatically expires if the continuing review & approval does not occur by the expiration date of the current approval.

Do NOT let your projects simply expire if you are done with them.

Your research protocols must remain open with the IRB as long as you are analyzing information. Once this is complete and activities are limited to manuscript preparation you may choose to close the project. IRB approval of the final closure formally ends the IRB approval of the project.

Project Closure: Submit the IRB Project Closure Request Form for IRB approval to formally close your project.

Record Retention Requirements (See Page 22) Communicating the results to subjects or the community from which subjects were recruited (if

appropriate)

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Record Retention

Both the official research file and the investigator’s research records must be retained in accordance with the VHA Records Control Schedule (RCS 10-1).

The official research file is a permanent record, which is maintained by VHA for 30 years after cut off of the records (cut off being the end of the fiscal year in which the study closed) and then transferred to the National Archives and Records Administration (NARA).

VHA has requested that NARA schedule the retention period for the investigator’s research records and is currently pending. Therefore, all investigator records must be maintained indefinitely by the investigator or the service in which the investigator works until schedule by NARA.

Please work with your Careline (MVAC, D&T, GEC or Service Line), the ISO and PO to develop secure storage of records in line with this VHA requirement.

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Rules & Tools

For Investigators to remain compliant during research, find these additional documents in addition to this PowerPointInvestigator Duties/Responsibilities List CPRS Notes GuidanceInvestigator Regulatory Binder GuidanceInvestigator Guidance Proper Informed Consent

Also for your reference:A Compliance Awareness:

http://vaww.visn2.med.va.gov/network/compliance/index.cfmCompliance Ethics Hotline — 1-888-214-9892

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Thank you for your participation in HRPP TrainingThank you for your participation in HRPP TrainingIf you need additional guidance, please contact the HRPP Office to set up a meeting to review the forms required for submission. The HRPP Administrator will meet with you in regards to the regulatory requirements for submission. You may also request to meet with the IRB Chair if you have questions that are more in-depth regarding the research science/methodology.

Human Research Participant Protection Program800 Irving Avenue | Syracuse, NY 13210 Paul Dougherty, DC, IRB Chair

Paul.Dougherty@va.gov Andrea L. Hahn, HRPP Program Administrator

315-425-4400 ext. 53607Andrea.Hahn@va.gov

Colleen A. Marcely-Temple, HRPP Program Assistant

315-425-4400 ext. 53591Colleen.Marcely-Temple@va.gov

24Click here for HRPP CertificateClick here for HRPP Certificate