OHRS News Email - Announcements and Quarterly Forms Update Fall 2017

October 10, 2017

Announcements:

1. OHRS Staff Restructuring

The Office for Human Research Studies is excited to announce a restructuring of our protocol focused Human Research Coordinator (HRC) staff with the aim to better serve the DF/HCC Research Community.  HRCs have been reorganized into teams by disease groups.  Disease programs can expect to begin working with the same HRCs regularly as the protocol assignments are transferred to the new teams.  The disease program used to assign a team and HRC will come from the “Primary Management group” in OnCore.

Ongoing research studies will be reassigned to an HRC from the corresponding team and when updated this will be reflected in OnCore and OncPro.  The OHRS website will also be updated with this information.  If the Teams need to be adjusted due to significant changes in workload, the OHRS Website will be updated with this information.

Please see below for the current HRC team assignments by disease group.

Team A

Team B

Team C

Polly Goodman, CIP, Team Lead

Elizabeth Mutti                  Elizabeth Ehrlich, CIP           Karen Cruz                        Sephora Hollant

Nicole Burbul, Team Lead   

Susie Weisenburger             Sean Murphy                      Phil Oettgen                      Judelle Cummins

Casey Rich, CIP, Team Lead  

Damien Christian            Ha Nguyen                    Shannon Peabody       Elizabeth Tabbut

Disease Groups:

  •    Breast Cancer
  •    Cutaneous and Melanoma
  •    Gastrointestinal Malignancies
  •    Genetics
  •    Gynecologic Cancer
  •    Head and Neck
  •    Immunotherapy
  •    Lung Cancer

Disease Groups:

  •    Computational Biology
  •    Cell Biology
  •    Epidemiology
  •    Imaging
  •    Immunology
  •    Neuro-Oncology
  •    Nursing
  •    Pediatric Oncology
  •    Proton
  •    Radiation Oncology
  •    Risk and Disparities
  •    Surgery
  •    Survivorship
  •    TPETT (Phase I)

Disease Groups:

  •    Benign Hematology
  •    Genitourinary Oncology
  •    Kidney Cancer
  •    Leukemia
  •    Lymphoma
  •    Multiple Myeloma
  •    Outcomes Research
  •    Sarcoma
  •    Transplant

 

2. OncPro Processing Delays:

OHRS is again experiencing minor delays in the posting of protocol documents to OncPro.  Please contact Brian_Durie@dfci.harvard.edu or Jonathan_Matichak@dfci.harvard.edufor help with any urgent OncPro postings.

3. Single IRB Update:

If you are an Investigator and have any questions about using a Single IRB for the review of a PI-Initiated Multi-Center Research Protocol please contact Polly_Goodman@dfci.harvard.edu and Emily_Eldh@dfci.harvard.edufor guidance.

Quarterly Forms Updates:

1. New and Revised Templates:

1. Protocol Template for Data/Specimen Collection and Use NEW

2. Protocol Template for Non-Clinical Research NEW

3. Protocol Template for Biomedical Research

4. Biomedical Consent Template

5. Social/Behavioral Consent Template

6. Screening Consent Template

7. Pregnant Partner Consent Template

Revisions to the DF/HCC templates are described in the template logs.  The DF/HCC Templates and Logs can be found on the OHRS under “Creation” and at the following link:http://www.dfhcc.harvard.edu/research/clinical-research-support/creation/forms-and-templates/

2. New and Revised Forms:

New Project Application – Non-Clinical Research NEW

New Project Application – Not Human Subjects Research Determination NEW

New Project Application – Clinical Trials

New Project Application – Single IRB

Amendment Form – Single IRB

Notice of Request to Initiate Reliance Agreement – Single IRB

Summary of New and Revised Forms:

New Project Application – Non-Clinical Research NEW

New Project Application – Not Human Subjects Research (NHSR) Determination NEW

New Project Application – Clinical Trials

    • The following new project applications have been combined into one application with the aim of simplifying the application process for investigators:
      • New Project Application for Social/Behavioral Research (RETIRED)
      • New Project Application – Prospective Collection of Human Material and/or Clinical Data for Research Purposes (RETIRED)
      • New Project Application – Research Use of Retrospective Medical Records and/or Clinical Data for Research Purposes (RETIRED)
    • The following forms have been combined into one applicationwith the aim of simplifying the application process:
      • New Project Application – Request for Exemption from IRB Review or Determination that Activity is Not Human Research (RETIRED)
      • Request for Quality Improvement Determination (RETIRED)
    •         Part D:  Added “Drug/Device/Biologic provided by” column to the table.
    •         Part E: Added Operating Room as an option for where the research may take place.
    •         Part F:  Added a new question to indicate whether the study should be listed in the DFCI Pathways System (for DFCI led studies only).
    •         Part F:  Added a new question to indicate whether the study should be routed to the Belfer Office for Dana-Farber Innovations (BODFI) for review of the plan for sharing of samples collected for this study.
    •         Administrative corrections.

New Project Application – Single IRB

Amendment Form – Single IRB

Notice of Request to Initiate Reliance Agreement – Single IRB

    • The following form has been removed from the website as a result of the development of this form: Request to Cede IRB Review (RETIRED)
    • Part A: Added Operating Room as an option for where the research may take place.
    • Part B:  Added a question to indicate whether the study has been submitted to the Office for Research Integrity for Institutional Conflict of Interest Review.
    • Part D:  Added “Drug/Device/Biologic provided by” column to the table.
    • Removed “Part C – Subject Notification” and added a statement to part B indicating that study teams should refer to the Single IRB approval documentation for instructions regarding reconsent.
    • Revised to add additional guidance and to remove references to the Harvard Catalyst reliance system as it has been decommissioned.  Harvard Catalyst reliance system has been replaced with the SMART IRB system.

New and Revised Information Sheets and Investigator Resources:

IS – Guidance – Electronic Consent NEW

IS – Guidance – Review of Data Specimen Collection NEW

Human Research Protections Program Tool Kit NEW

    • This is a series of worksheets and checklists which provide guidance and decision-making tools regarding various areas of human research protections.  Investigators are encouraged to use these tools in the design and development of new research projects.

IS – Operations – Quick Reference for New Protocol Submissions

    • Revised with new forms version dates.

IS – Operations – Guidance for Single IRB Review Process

    • Revised to add more clarity regarding the review of requests to rely on an external IRB.

IS – Policy – Major Deviation/Violation/Exception

    • Revised the list of policies and procedures, regulations and regulatory oversight agencies that govern changes to the IRB-approved research.
    • Revised to provide a definition of “Corrective Action.”

IS – Policy – Use of an Unapproved Drug to Treat an Individual under a Single Patient IND or Emergency Use IND

    • Updated FDA links to guidance documents and required FDA forms

IS – Index – Information Sheets

    • Revised to include new Information Sheets

 4. Forms Implementation and Upcoming Trainings: 

  • Beginning Monday, November 9, 2017, older versions of the forms and templates listed above will no longer be accepted by OHRS.  Study teams are advised to always use the most recent version of each form from the OHRS website. 
  • All forms and information sheets are located on the OHRS website at: www.dfhcc.harvard.edu/research/clinical-research-support 
  • Quarterly OHRS Forms Training will be held on Friday, November 3, 2017 in the DFCI Yawkey Conference Center Room 307 from 10:00-11:00am.

Please email the DFCI OHRS Submit email box at: OHRS_Submit@dfci.harvard.eduwith any problems related to a submission made via OHRS Submit (e.g. incorrect protocol number, incorrect forms, etc.).  The OHRS Intake team will help take care of your request.

If you have any questions, please contact us.

Office for Human Research Studies

Dana-Farber Cancer Institute
450 Brookline Ave., OS229
Boston, MA 02215
Phone: 617-632-3029
Pager: 42299