Office for Human Research Studies
DANA-FARBER / HARVARD CANCER CENTER
OHRS Use Only:
DFCI Protocol No.:
NEW PROJECT APPLICATION – RESEARCH USE OF RETROSPECTIVE MEDICAL RECORDS
AND/OR PREVIOUSLY COLLECTED SPECIMENS
Instructions: This form should be used for projects that are limited to research using existing data/samples.
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All new research applications must be reviewed and approved by the appropriate disease/discipline based program leader
prior to submission to the OHRS.
A front sheet must accompany this form.
A Request for Waiver or Alteration to Use or Disclose of Protected Health Information in Research must accompany this
form.
A site-Principal Investigator is required for all institutions from which data will be accessed.
Protocol documents are not required for DF/HCC-only studies. All sources of data/specimens must be specifically
identified.
Please refer to the New Application Checklist (last page) to ensure that the submission is complete. Incomplete
applications will be returned.
All applications must be typewritten.
Please contact the OHRS, (617) 632-3029 or ohrs@dfci.harvard.edu, with any questions.
If this is a resubmission of a previously disapproved or withdrawn study, please provide the prior protocol number:
Part A – Study Information
1. FULL PROTOCOL TITLE:
2. DF/HCC Principal Investigator Name:
3. Primary Study Contact Name:
I have completed the required human subject research training (see EDU-102 Human Subject Protection Training Requirements)
4. Study Description: Please provide in detail a description of the proposed research, including: (a)
background/rationale (b) study objectives (c) study design/procedures (d) data collection procedures (e) data analysis
(f) statistical considerations and (g) references.
5. Protocol Type: [pull down]
If Ancillary, provide parent protocol #:
6. Cancer related studies only:
Primary Disease Program [pull down]
or
Primary Discipline Based Program: [pull down]
7. Source(s) of Medical Records: Check all that apply.
Not Applicable (Skip to Question 8)
Hospital Medical Record
Electronic Medical Record
Office Records
Other, please specify:
Version: 01.08.16a
8. Record Review Process: How and by whom will the records be reviewed?
9. Dates of Records: Please indicate the range of dates (MM/DD/YYYY) of the records that will be reviewed.
From:
To:
(Dates must be retrospective.)
10. Source(s) of Specimens: Check all that apply. Please note: the IRB requires proof of IRB approval for specimens
obtained from outside collaborators.
Not Applicable (Skip to Question 11)
Collaborators within DF/HCC, specify by protocol number, institution and/or lab:
Collaborators outside of DF/HCC, specify by name of PI, institution and/or consortium:
Commercial sources, identify:
Other, specify:
a. Were the specimens obtained as part of clinical care? Y
N
b. Will the specimens be sent to individuals or institutions outside of DF/HCC?
If yes, what information about the specimens will be sent with the samples?
Y
N
11. Data to be Collected:
a. Check all that apply:
Personal data (name, address, PCP)
Demographic data (age, gender, vital status)
Coded encounter data (diagnoses, dates)
Reports, clinic/office notes
Billing Data
Laboratory Data
Images
Other, specify:
b. Explain why the research could not be done without access to the data.
c. Anticipated number of individuals whose records will be reviewed:
12. Data to be Used For:
Publication
Oral Presentation
Other, please explain:
13. Training: In addition to the required CITI training, please describe the training that has been provided to the
individuals who will be reviewing the medical records and/or analyzing the specimens so that the IRB is assured that
privacy and confidentiality are protected.
14. Benefits: Please describe the expected medical, scientific and research benefits of this research:
15. Privacy/Confidentiality:
What data points are you collecting? (For example: date of diagnosis, date of surgery)
Will the data be linked to the source? Y
N
New Research Application Form – Research Use of Medical Records
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Data that are coded, where the key to the code is accessible to researchers, are considered protected health information
(PHI) and subject to HIPAA regulations. Will any of the following identifiers be recorded with or linked by code to the data?
Yes
[Complete 15a-15e] No
[Skip to 16]
a. If yes, check all that apply:
Names
Date of Birth, Admission, Discharge or Death
Vehicle identifiers and serial #s (license
plate numbers)
Device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Biometric identifiers, including finger and
voiceprints
Full face photographic images and any
comparable images
Postal address information, other than town, city,
State, zip code
Telephone numbers
Fax numbers
Electronic mail addresses
Social security numbers
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license number
Internet Protocol (IP) address numbers
b. Describe how the data/health information will be stored and protected including the plan to protect the privacy
interests of participants;
(i) For paper-based information, include the following information: where the identifiable information will
be stored, who has access to the storage area, and how access will be monitored.
(ii) For electronic information, include the following information: how electronic security will be maintained,
what password protections and virus software are enabled, and how the system will be audited.
c. Who will have access to the data/health information?
d. Will the data/health information be de-identified or destroyed when no longer needed for research purposes?
Y
N
If no, explain why it must be retained, including in part whether it is needed for a health purpose, legal or
institutional requirement, or other reason.
e. What will the process be for releasing identifiable and non-identifiable information to researchers not listed on
this protocol and/or non-DF/HCC researchers?
f. How will the data be labeled/coded?
g. When identifiable information is requested from outside researchers, how will IRB approval of their research be
confirmed and who will be responsible for doing so?
16. Risks: Please describe the risks involved for individuals whose records/specimens will be used in this study,
including the risk to privacy/confidentiality of information, the risk posed by the data collection procedures, and how
such risks will be minimized.
17. Informed Consent: Will informed consent be obtained?
Yes: This form is not applicable. Please submit a New Project Application – Prospective Collection
of Human Material and/or Clinical Data for Research Purposes
No, you must request a Waiver of Informed Consent.
Please address the following issues (N/A is not an acceptable answer):
(1) Explain why/how this research involves no more than minimal risk to the participants or their privacy.
(2) Explain why the waiver or alteration will not adversely affect the rights and welfare of the participants.
(3) Explain why the research could not practicably be carried out without the waiver or alteration.
(4) Explain how, whenever appropriate, the participants will be provided with additional pertinent information after
participation.
18. HIPAA Authorization: You must also submit a Waiver of Authorization. Please fill out the following form and submit
with this application: Request for Waiver or Alteration to Use or Disclose of Protected Health Information in Research
New Research Application Form – Research Use of Medical Records
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Part B – Sponsor information
1.
APPLICANT INSTITUTION (Select Only One)
Beth Israel Deaconess Medical Center (BIDMC)
Beth Israel Deaconess Medical Center – Needham
Boston Children’s Hospital (BCH)
Brigham and Women’s Hospital (BWH)
Dana-Farber Cancer Institute (DFCI)
Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) at Faulkner Hospital (DFCI @ FH)
Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) at Milford Regional Medical Center (DFCI @
Milford)
Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) in clinical affiliation with South Shore
Hospital (DFCI @ SSH)
Dana-Farber/New Hampshire Oncology-Hematology (DFCI @ NHOH)
Massachusetts General Hospital (MGH)
Massachusetts General Hospital at North Shore Cancer Center (MGH @ NSCC)
Massachusetts General Hospital at Emerson Hospital (MGH @ EH)
Other [Specify]:
2.
INITIATOR OF THIS STUDY
Who designed and will be responsible for the oversight and coordination of the study,
regardless of funding/support?
[Note: If the DFCI or DF/HCC Investigator designed and will be responsible for the oversight of this study, Part D must
also be completed.]
Part C – Monitoring and Site Utilization
1. RESOURCES
Describe the resources available to ensure adequate support of the study, including the plan for managing all
unanticipated problems and study modifications:
2. DF/HCC INITIATED STUDY
Does not apply – not DF/HCC Initiated
Please complete questions (a) and (b) below if a DF/HCC Investigator (including Satellite or DF/PCC Affiliate
Investigators) designed and will be responsible for the oversight of this trial, regardless of funding/drug support.
a) List all Institutional Participants under an Outside IRB that are expected to participate in
the proposed study:
Institution Name:
1)
2)
3)
4)
5)
Please Note:
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City,
State/Country:
Federal Wide
Assurance (FWA) #:
IRB of Record
(if known):
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All multi-center participating sites must have a Federal Wide Assurance (FWA) on file with the Office for Human
Research Protections (OHRP).
To check an institutions FWA # please go to the website: http://ohrp.cit.nih.gov/search/
Please refer to DF/HCC SOP MULTI-100 and other associated multi-center documents on the DF/HCC Clinical
Research Support Website for more information about conducting PI Initiated multi-center studies.
No research may be conducted at any outside multi-center sites without approval of an associated Add
Site Amendment submission. Once the outside sites IRB approvals become available, the multi-center sites
noted above should be added by submitting the Request to Add New Site form via OHRS submit.
Please contact Bryan Peterson at bryan_peterson@dfci.harvard.edu with questions related to outside
multi-center sites.
Part D - Signatures
My signature below provides written assurance that I have reviewed the proposed study with the appropriate
disease program members and find that it meets the goals and priorities of this disease program and does not
compete with currently active research.
__________________________________
Disease Program Leader Signature
________
Date
Print name
As DF/HCC Principal Investigator, my signature below provides written assurance that I have reviewed the New
Project Application, protocol, consent form, and required supplemental forms and confirmed that the information
provided is accurate. My signature also assures that identifiable information will not be reused or disclosed except as
required by law; for authorized oversight of research; or for other research only if that research has been reviewed
and approved by the DFCI IRB with specific attention to and approval of the issue of access to this identifiable
information.
______________________________________________
Signature of Overall DF/HCC Principal Investigator
________
Date
New Project Application completed and/or submitted by:
Name:
Date:
Phone:
E-mail:
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Print name
Part E – New Application Submission Checklist
Please include all of the following checked items with your submission to the Office for Human Research Studies (OHRS).
Missing documents will delay acceptance of your submission. For documents requiring signatures, please either scan
signed version for submission or submit with electronic signature.
Check the items included in this new research application submission:
Completed Front Sheet.
Completed and signed New Project Application Form – Retrospective Use of Medical Records
and/or Previously Collected Specimens.
Completed Research Funding Form.
Completed Department of Defense Supplement Form. (
which receive any funding from the Department of Defense.
N/A) This form is a required attachment for all trials
Signed Statement of Investigator Form(s) (Principal Investigator and Site Responsible Investigator).
Scan signed versions as one document for submission via OHRS Submit.
Note: These individuals must be added to the protocol front sheet.
Study Specific Research Team Update. Please include all research team members and any group
mailboxes that will need to receive email communications about this trial.
Note: These individuals should not be added to the protocol front sheet. (
N/A. There are no additional
team members besides the Overall PI/Site PI/ Primary Study Contact listed on the Front Sheet).
Signed Co-Investigator Forms for all Co-Investigators have been received and filed in the Lead Site
Regulatory Binder. Please do not submit these to OHRS.
Note: These individuals should not be added to the protocol front sheet. ( N/A. There are no additional team
members besides the Overall PI/Site PI/ Primary Study Contact listed on the Front Sheet).
Outside Interest Log Sheet for all applicable Investigators and Research Team Members.
Request for Waiver or Alteration to Use or Disclose of Protected Health Information in Research.
Scan signed version of Request for HIPAA Authorization for submission via OHRS Submit.
Federal Grant Application (excluding appendices) that has been or will be submitted to the granting
Federal agency. (
N/A)
Completed and Signed Multi-center Coordinating Form This is required for DF/HCC initiated multi-center
studies. A Multi-Center Coordinating Committee Checklist must be completed and submitted to the
MCC for approval to conduct DF/HCC Investigator Initiated Multi-Center research. Documentation of MCC
approval must then be submitted to OHRS. Please contact the QACT MCC Regulatory Affairs Specialist: Bryan
Peterson, (617) 632-6768 or
bryan_peterson@dfci.harvard.edu ( N/A)
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IRB Approval Letters from collaborators outside of DF/HCC. (
N/A)
BIDMC Confirmation of Investigator Resources Form. (
N/A)
This form is required for all studies where BIDMC or its satellite sites are participating.
IRB DETERMINATION
Submissions received by the Office for Human Research Studies eligible for expedited IRB review will be reviewed by
an IRB member via an electronic workflow. A separate Electronic Review Documentation Form or Review Workflow
will document any expedited IRB review determinations. Submissions not eligible for expedited IRB review will be
reviewed by the Full IRB and the meeting minutes will document the review determination.
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