Sponsored Awards Management

Financial Conflicts of Interest in Sponsored Research Policy

• Annual COI Disclosure Form
• COI Disclosure Statement
• Request for Information s of Interest in Sponsored Research Policy

• Access to Closed and Archived Research Records
• CMS Policy 
• Data Encryption Policy
• Limited Data Sets and Data Use Agreements
  • Data Use Decision Tree
  • HSL Data Use Agreement Template
    • Start Ironclad Workflow
    • Instructions
• Records Destruction Authorization Form
• Sensitive Data Retention and Destruction Policy
• Sensitive Data Security Policy
• Sensitive Data Sharing Policy
• Sensitive Data Suppression Policy
• Staff Changes and Data Access Policy
• Technical Equipment Policy

Review our procedural guidelines

Procedure for Review of external requests to conduct research or gather data from 
Hebrew SeniorLife Business Lines

All inquiries and requests for conducting research by external researchers must be routed to the Human Subject Protection Office (HSPO)

Before any research involving staff, patients, residents or data can be conducted at HSL, the External Researcher Request Form must be completed by the requesting Researcher and sent to the HSPO with the applicable study materials such as:  Protocol, consent form, participant-facing documents etc.

The HSPO will manage the contact with the External Researcher and collect all relevant documentation for HSL. Once documents are received, the HSL HSPO will then work with the appropriate individual from Senior Leadership to obtain review and approval.

Each person from Senior Leadership who is responsible for the business line, is expected to respond with an affirmative or with questions that will be directed to the Researcher by the HSL HSPO.

Approval will not be communicated to the External Researcher until all issues have been resolved to the satisfaction of Leadership.

The External Researcher must obtain and IRB determination from the IRB with jurisdiction over the researcher and provide this documentation to the HSL HSPO.

Research cannot commence at any HSL business line until all documents and approvals are in place.

When all documents and approvals are in place, the approval will be communicated by the HSPO either to the External Researcher or to the HSL applicable Senior Leadership who is approving the request.
        
HSL reserves the right to rescind approval based on institutional policies or any unanticipated problems that may occur that impact patients, residents or resources of the institution.

• For Data requests, or research involving patients and resident data, the Chief Information Officer will need to be included at the onset of processing the request to determine if IT will require additional resources to provide the requested data.  HSPO will ask for written approval of the request.
• The HSPO will communicate the name of the PI, Title of the project to the CIO before IT may distribute data to an external researcher.  No data can be provided to an external researcher without approval from Senior Leadership which will be communicated through the HSPO.
• IT is not the source of approval for any data sharing.
• HSPO will also contact the Privacy Officer to alert this Department of the request. The Privacy Officer will be responsible for corresponding with the External Researcher about any HIPAA requirements such as accounting disclosures.

HSL Senior Leadership responsible for final External Research Approval:

Kimberly Brooks, Chief Operating Officer, Senior Living 
KimBrooks@hsl.harvard.edu 

Ernest Mandel, MD, Chief Medical Officer 
ErnestMandel@hsl.harvard.edu 

Alvaro Pascual-Leone, MD, PhD, Medical Director, Wolk Center for Memory Health APLeone@hsl.harvard.edu  

Tammy Retalic, Chief Nursing Officer and Vice President of Patient Care Services TammyRetalic@hsl.harvard.edu

To be consulted by HSPO as applicable:

Eric Rogers, Chief Information Officer  
EricRogers@hsl.harvard.edu

Jamie Curtis, Assistant General Counsel and Director of Compliance and Privacy, Legal & Compliance
JamieCurtis@hsl.harvard.edu
 

External Research Request Form and Procedure

Indirect Costs (IDC) are also known as facilities and administrative costs or overhead.  The Marcus Institute's IDC rate is the federally approved percentage applied to sponsored projects to recover the costs associated with performing the activities of the research project and managing the research project. 

View our Indirect Costs Agreement

The following policies and templates apply to Non-Marcus Institute sponsored awards that are managed by the Marcus Institute.  For guidance on specific purchasing and reimbursement policies, please contact your Research Administrator.

• Non-Marcus Institute Sponsored Awards Management Policy
• Checklist
• Cost Share Letter of Commitment