OHRS Use Only:
DFCI Protocol No.:

NEW PROJECT APPLICATION forSECONDARY USE RESEARCH

Use this form to submit research that involves:
  1. Medical Record Review: Research involving materials (data, documents, records,or specimens) that have been collected (retrospectively)or will be collected (prospectively) solely foranother non-research purpose (e.g. clinical observations, medical treatment or diagnosis occurring in a non-research context). Data and specimens may exist under another IRB approved research study. Do not submit on this form if your research involves the use of specimens for basic science; please use the Non-Clinical New Project Application Form.
  1. Exempt Secondary Research for which consent is not required. Secondary research uses ofidentifiable private information or identifiable biospecimens may be determined to be Exempt if at least one of the following criteria is met:
i. The identifiable private information or identifiable biospecimens are publicly available
ii. Recorded information, which may include information about biospecimens, cannot be readily identified (directly or indirectly) and the investigator does not attempt to contact subjects and will not reidentify subjects.
iii. The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA[1]. HIPAA covers data only, not specimens.
iv. Research by or behalf of the Federal department/agency using government generated or collected information, compliant with relevant privacy policies.
Instructions to submit:
  1. If this is the first submission of the Principal Investigator, please ensure they complete the applicable sections from the Training Checklist for New DF/HCC Researchers. In particular, the Principal Investigator will need to have an OnCore profile.
  2. To gain access to make the submission, please request OncPro Access and OHRS Submit Access here.
  3. Complete this form (typewritten). Please refer to the last section of this form to identify additional documents that will need to be completed prior to submission.
  4. Submit all the submission documents through OHRS Submit. Incomplete applications will be returned.
Please contact the OHRS, (617) 632-3029 or , with any questions.

If this is a resubmission of a previously disapproved or withdrawn study, please provide the prior protocol number:

If this research has been previously reviewed by another IRB, please list the IRB and describe the outcome:

Part A – General StudyInformation

Study Title
DF/HCC Principal Investigator Name
Associated DFCI IRB Approved Protocols #(s): / OncDRS Request ID: / OncDRS Request Attached
Not applicable
Primary Management Group / This is the group/program that is running the trial.
Disease Program [pull down]N/ABreast CancerGastrointestinal MalignanciesGynecological CancerHead & Neck CancerKidney Cancer (renal/non-prostate GU)LeukemiaLung Cancer (thoracic)LymphomaMyelomaNeuro-OncologyPediatric OncologyProstate CancerSarcoma ProgramCutaneous Oncology MelanomaOther
or
Discipline Based Program: [pull down]N/ABiostatisticsCancer Cell BiologyCancer DisparitiesCancer EpidemiologyCancer GeneticsCancer ImagingCancer ImmunologyCancer NursingCancer Risk ReductionCancer SurvivorshipChemopreventionInvasion, Metastasis, AngiogenesisOutcomes ResearchPalliative CarePediatric OncologyRadiation OncologySurgical OncologyTranslational Pharmacology/Early TherapeuticsTransplantOther
Application completed and/or submitted by: / Name: / Phone:
E-mail:

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Part B – Sponsor Information

1.INITIATOR OF THIS STUDY

  1. Who was responsible for the initial design and development of the study? (e.g., investigator, industry)
  1. Who will be responsible for the oversight and coordination of the trial, 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.]

2. RegulatorySponsor Study Number (If Applicable):

Part C – Study Overview

  1. STUDY SUMMARY: Please briefly summarize the proposed research using language understandable to a non-scientific IRB member. If there is language in the protocol document that would be understandable to a non-scientific IRB member please provide the section of the protocol where this can be found.
  1. Enrollment - The Protocol / OncDRS Request must specify:

a.Total number of study records / samples needed to conduct the research:

b.DF/HCC total enrollment across all sites (if different from above):

  1. Informed Consent:TheProtocol / OncDRS request must include a description of therational for requesting a Waiver or Alternation of Informed Consent, or information regarding whether consent was obtained or waived under a previous research protocol. The IRB may grant waivers or alterations to informed consent requirements if sufficient justification is provided.

See DF/HCC CON-100 and OHRS Guidance on Requirements for Informed Consent for additional information.

We request a Waiver of Informed Consent.

We request an Alteration of Informed Consent.

  1. HIPAA: Subjects must provide written Authorization for investigators to access their medical records. If the research requires a waiver of Authorization, please indicate the request for a waiver below.

Sufficient justification for the waiver MUST be included in the Protocol / OncDRS request including:

1) a description about how the information will be used/disclosed;

2) the use/disclosure involves no more than minimal risk to privacy;

3) a plan to protect identifiers from improper use and disclosure;

4) a plan, if applicable, to destroy identifiers;

5) whether the PHI will be used or disclosed to any other person/entity, when, why and under what circumstances, and how others will protect the privacy and confidentiality of the information; and

6) why it is impracticable to obtain written authorization.

We request for Waiver of written Authorization to use or Disclose Protected Health Information in Research.

HIPAA Authorization was provided by the subject when they were consented to the primary study.

HIPAA Authorization was waived for the primary study.

  1. FDA REQUIREMENTS

Does this study involve the use of anIn Vitro Diagnostic Test and/or Laboratory Developed Test?For guidance please see: FDA Laboratory Developed Tests Webpage and FDA Discussion Paper on Laboratory Developed Tests (LDTs) Dated January 13, 2017). If yes, do not use this application form. Please submit your new protocol on the Clinical New Project Application Form.

Part D –Site Utilization

  1. Identify all sites at which this research will be conducted:

Lead
Site* / Participating
Site / DF/HCC Sites and Satellites / Site PI Name
Beth Israel Deaconess Medical Center (BIDMC)
BIDMC at Needham
Boston Children’s Hospital (BCH)
Brigham and Women’s Hospital (BWH)
BWH at Faulkner Hospital
Dana-Farber Cancer Institute (DFCI)
DFCI at Milford
DFCI at St. Elizabeth’s
DFCI at South Shore
Dana-Farber/New Hampshire Oncology-Hematology
DF/BWCC in Clinical Affiliation with South Shore Hospital
Massachusetts General Hospital (MGH)
MGH at North Shore
MGH at Newton-Wellesley Hospital
MGH / Emerson Hospital

*There should be only one lead site, which is the primary institution of the overall PI.

Part E – Additional OnCoreInformation

  1. Key Personnel:

Does this study have a Primary Study Contact?
If yes, please complete the following:
Name:

Email:

Phone:

The Primary Study Contact has completed the required training (see EDU-100 Training Requirements for Research Personnel).

  1. Protocol Involves (check all that apply as listed in the protocol document, even if not part of the research but is mandated by the protocol document):

Medical Record Review
Genetic Studies
Other:
  1. Dates of Records (if applicable): Please include in the Protocol / OncDRS Request the date range for the records that will be reviewed and please include the dates here:

From: To:

Part G- Signatures

As DF/HCC Principal Investigator, my signature below provides written assurance that I have reviewed the New Project Application, Protocol document / OncDRS Request, 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 an IRB with specific attention to and approval of access to this identifiable information.
I certify that:
1.The protected health information for which use or access is sought is necessary for research purposes.
2.The protected health information that will be reviewed is the minimum necessary for this research.
3.I will track and report all disclosures of PHI per my institutional policies on ensuring privacy and confidentiality (HIPAA Privacy Rule).
______
Signature of Overall DF/HCC Principal Investigator Date Print name

Part H– New Application Submission Checklist

Please include all itemswith your submission to the Office for Human Research Studies (OHRS).

  • This page must be completed or the application will be returned.
  • Missing documents will delay acceptance of your submission.
  • For documents requiring signatures, please either scan signed version for submission or submit with electronic signature.

Completed(Submitted if applicable) / Not
Applicable / Form and description
New Project Application Form – Secondary Use
Protocol Document or OncDRS Request
  • Please use the “Data/Specimen Collection and Use” Protocol Template on the OHRS website.
  • Please note that the grant application is NOT a protocol document.

Research Funding Form
Statement of Investigator Form(s)
  • One is always required for the Principal Investigator
  • If there are other DF/HCC sites, then each Site Responsible Investigator must complete this form also.
  • Scan signed versions as one document for submission via OHRS Submit

Co-Investigator Forms (DO NOT SUBMIT – confirm all Co-Investigator forms have been received and filed in the Lead Site Regulatory Binder.
Research Team UpdateForm. This is only applicable for trials where BIDMC is the only participating site. The study staff is responsible for managing research team members in OnCore for all other DF/HCC sites.
Outside Interest Log Sheetforall applicable Investigators and Research Team Members.
Federal Grant Application – excluding appendices. Required only if review of the grant is required by the institution or funding agency.
Department of Defense Supplement Form
Required for all trials which receive any funding from the Department of Defense.

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[1] 45 CFR parts 160 and 164, subparts A and E, for the purposes of ‘‘health care operations’’ or ‘‘research’’ as those terms are defined at 45 CFR 164.501 or for ‘‘public health activities and purposes’’ as described under 45 CFR 164.512(b)