Human Research Participant Protection (HRPP) Training for New Investigators and Staff - PowerPoint PPT Presentation

About This Presentation
Title:

Human Research Participant Protection (HRPP) Training for New Investigators and Staff

Description:

The ICF and HIPAA original documents must be placed in the subject binder and a copy: ... Do NOT let your projects simply expire if you are done with them. – PowerPoint PPT presentation

Number of Views:140
Avg rating:3.0/5.0
Slides: 25
Provided by: VISN86
Learn more at: http://www.visn2.va.gov
Category:

less

Transcript and Presenter's Notes

Title: Human Research Participant Protection (HRPP) Training for New Investigators and Staff


1
Human Research Participant Protection (HRPP)
Training for New Investigators and Staff
  • Syracuse VAMC HRPP Office
  • Serving Bath, Canandaigua
  • Syracuse VA Medical Centers

2
Introduction
  • Welcome 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
  • RD Website http//www.visn2.va.gov/apps/visn2sh
    ared/research/syr/syrforms.cfm
  • Syracuse 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.

3
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 RD (ORD) rules
  • and regulations,
  • Local Syracuse VAMC RD rules.

4
RD 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.
  • RD Website http//www.visn2.va.gov/apps/visn2sha
    red/research/syr/syrforms.cfm
  • or
  • Syracuse Research Service SharePoint (VA Access
    Only) https//vaww.visn2.portal.va.gov/sites/syr/
    research/default.aspx
  • or
  • Contact the HRPP Office

5
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 PIs responsibility to ensure
    that staff working on their research protocol(s)
    remain compliant with required research
    training. 

6
New Research Protocol Submissions
  • The current IRB Submission Forms can be found at
  • 1) RD Website http//www.visn2.va.gov/apps/visn
    2shared/research/syr/syrforms.cfm
  • or
  • 2) Syracuse Research Service SharePoint (VA
    Access Only) https//vaww.visn2.portal.va.gov/sit
    es/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 RD Signatures needed on the
    Scope of Work Documents.

7
  • 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.

8
VA Investigator
  • Any individual who conducts research approved by
    a VA Research Development Committee including
  • VA appointment on VA time
  • Full part-time VA employees
  • Without compensation (WOC) VA employees
  • Appointed or detailed to VA under the
    Intergovernmental Personnel Act (IPA)

9
Investigator Responsibilities
  • Upholding professional ethical standards
    practices
  • Adhering to all applicable requirements for
    conduct of research the protection of human
    subjects
  • VA
  • Other Federal requirements
  • Syracuse Research and Developments 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

10
Investigators 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 RD SOP 151-06 Impaired Decision
    Making Capacity (IDMC) under Policy and Procedure
    on the RD website.)

11
Investigators 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)

12
Investigators Responsibilities HIPAA
  • Investigators are responsible for obtaining HIPAA
    authorization for the use disclosure of the
    subjects 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.

13
Investigators 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

True Informed Consent encompasses BOTH the
Process and the Form
14
Investigators Responsibilities Informed
Consent Continued
  • The ICF and HIPAA original documents must be
    placed in the subject binder and a copy
  • 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.
  • copy to medical records for scanning into CPRS
    within one week (use Internal Clinical Records
    for Scanning Form).
  • copy to Research Compliance Officer within ONE
    WEEK of subject enrollment.
  • copy to Pharmacy, if study drug involved, before
    study drug released to subject. Also provide copy
    of 10-9012 with consent to research pharmacy.

15
Investigator Responsibilities Informed Consent
Continued
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! CPRS Notes should be used for ALL
participants enrolled on your study, UNLESS
otherwise waived by the IRB.
  • GO! Submit Informed Consent copies to the HRPP
    Office AND for
  • CPRS scanning WITHIN ONE WEEK of enrollment.

16
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 VA VHA Handbook 1200.5 IRB SOP 151-02
Emergency exception of ICF Not allowed Allowed Not allowed
ICF includes mandatory inspection of subjects 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.
17
Investigator Responsibilities Reporting
Deviations, Complaints, Problems, SAEs
  • Reporting deviations from the protocol
  • subject complaints to the IRB in a
  • time frame specified by
  • RD SOP 151-17
  • ORO
  • 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/

18
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 protocol
  • Changes to the IRB-approved informed consent form
  • ONE EXCEPTION
  • Eliminating apparent immediate hazard to the
    subject
  • MUST promptly report these changes to the IRB!

19
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

20
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 RD signature on
    these documents for you)
  • (1) SYRACUSE VAMC ADDENDUM TO CLINICAL FUNCTIONAL
    STATEMENT FOR PIS
  • All 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/COORDIN
    ATORS/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)

21
Investigators 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)

22
Record Retention
  • Both the official research file and the
    investigators 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 investigators 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, DT, GEC
    or Service Line), the ISO and PO to develop
    secure storage of records in line with this VHA
    requirement.

23
Rules Tools
  • For Investigators to remain compliant during
  • research, find these additional documents in
  • addition to this PowerPoint
  • Investigator Duties/Responsibilities List
  • CPRS Notes Guidance
  • Investigator Regulatory Binder Guidance
  • Investigator Guidance Proper Informed Consent
  • Also for your reference
  • A Compliance Awareness http//vaww.visn2.med.va.g
    ov/network/compliance/index.cfm
  • Compliance Ethics Hotline 1-888-214-9892

24
Thank 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 Program
  • 800 Irving Avenue Syracuse, NY 13210 
  •  
  • Paul Dougherty, DC, IRB Chair
  • Paul.Dougherty_at_va.gov
  •  
  • Andrea L. Hahn, HRPP Program Administrator
  • 315-425-4400 ext. 53607
  • Andrea.Hahn_at_va.gov
  •  
  • Colleen A. Marcely-Temple, HRPP Program Assistant
  • 315-425-4400 ext. 53591
  • Colleen.Marcely-Temple_at_va.gov

Click here for HRPP Certificate
Write a Comment
User Comments (0)
About PowerShow.com