Application to Conduct Research Instructions

HealthPartners Research Foundation

 

 

All research projects conducted at HealthPartners must be approved by the appropriate subcommittee and by the HealthPartners Institutional Review Board or Animal Care and Use Committee. To start the process, the Application to Conduct Research must be completed.

 

There are separate applications for each type of grant. Click the link for the type of grant you want:

          Clinical Research (direct intervention with patient care),

          Health Services (care improvement using data, surveys, interviews etc.)

          Exemptions

                   category 1 & 2, (surveys)

                    category 4 (retrospective review of data/specimens)

                    release and/or use of coded or de-identified data or specimens

          Animal Studies

 

The Clinical and Health Services application forms can be used to apply for Full IRB Review or Expedited Review. These forms may not be used to apply for exempt research status. (Need help deciding which level of review is appropriate for your research? Contact the IRB Office, 651-254-3391.)

 

The completed application includes the completed form, the scientific merit section, the budget and all required appendices. All sections must be complete for a project to be considered.

 

The application form is available at the end of these instructions. The form runs in Microsoft Word and contains fields that you need to complete. To move from field to field, use either the tab key or click the field with the left button of your mouse.  

 

How to complete an application form prior to review:

1.     Make sure you are completing the most updated version of the appropriate form from this website.

2.     All application forms must be typed.

3.     Fill out all of the questions completely. (If there are questions about using the text form fields or checkboxes, please contact Research Administration at 651-254-2928).

4.     Make sure to include the e-mail addresses of the PI and Co-investigators.

5.     Fill out and attach the appropriate appendices required by responses in this application.

6.     Remember to attach supporting documentation: consent form(s), assent form(s), protocol, survey instruments, interview schedules, solicitation letters, advertisements, etc.  If there are items to come at a later date, please state this information in the application.

7.     Complete the checklist that accompanies each form to ensure all requirements for submission are completed so that review is not delayed.

8.     Submit the application and appendices along with the supporting documentation to Health Partners Research Foundation Office.


 

 

APPLICATION FORM

 

Cover Page

 

Title:

A good title is brief (up to 3 lines or up to 325 characters and spaces), clear and distinguishable from previous studies on the same topic. If appropriate, include pilot or feasibility in the title. Please do not exceed 325 characters or spaces, as it will cause problems on the bottom of the form. If you are having trouble cutting a long title down to three lines, feel free to repeat the full title in the lay summary.

 

HP PI:

The Health Partners Principal Investigator is the Health Partners employee who is responsible for all research activities. All projects must have a HealthPartners investigator working on the project.

 

Overall Principal Investigator:

If the study is in collaboration with another organization and the Principal Investigator is not the HP Principal Investigator, provide that person’s name, organization, address, and phone numbers.

 

Contact Person:

A person (other than the PI) at HP who is familiar with the study details and can assist the research administrative staff in the event that the HP Principal Investigator is not available as needed.

 

Timing:

Project Period: The proposed start date and the duration (i.e.: 9 months, 1 year, 18 months, 5 years, etc.).

Submission Date: Date the proposal was or will be submitted to the external funding agency.

 

Total Site Subjects:

Indicate the total number of subjects to be recruited at this site.

 

Total Subjects:

If this is a multi-center study, list the total number of subjects to be recruited from all sites.

 

Finance:

Funders: If there are more funding sources than space allows, record the primary sources and include a full description in the Resources and Expenses section of the application.

Status of Funding: Check the appropriate box. If the budget is still under negotiation, check the pending box and give a full explanation in the Resources and Expenses section of the application.

A copy of the budget and budget justification must be included as an attachment to the application.

 


Lay Summary:

A very brief overview of the project purpose and methods. This summary is limited to the space remaining on the first page of the application and is restricted to 1204 characters and spaces or about 12 lines of text. Anything beyond the space provided will be deleted. This summary must include a brief description of the project purpose and methods.

 

Personnel Page

Personnel: List all personnel on the project whether or not their time is budgeted or in-kind. Place an asterisk (*) before the names of key personnel. Key personnel are defined as, and should be limited to, individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not a salary is requested.

The amount of time each individual will devote to this project is listed as a percentage of full-time. If someone is spending one half day per week on project related tasks you would indicate this by putting 10% (4 hours out of a 40 hour work week). If someone works part-time, you should still indicate the percentage of full-time. Please remember no matter how many hours someone works, he or she cannot work more than 100% time.

 

Financial Interests Disclosure

Key personnel must complete either the Significant Financial Interests Disclosure Form or Declaration of No Significant Financial Interests form found in the list of required attachments.

It is the policy of HealthPartners Research Foundation that any person engaged in design, conduct or reporting of a sponsored research project conducted under the auspices of the Foundation must disclose significant personal financial interests related to the project, to the sponsor of the project, or to the Sponsor’s affiliated entity(ies).  If the Foundation determines that such an interest might reasonably appear to directly and significantly affect the sponsored project, the Foundation will take steps either to manage or eliminate the conflict of interest.

 

This policy applies to any researcher, physician, IRB member or research committee member or employee responsible for the design, conduct or reporting of a research project at a HealthPartners facility sponsored by the government or private industry, including HPRF.

 

All financial disclosures must be updated by the researcher during the period of the project as new reportable Significant Financial Interests are obtained.  Researchers have a continuing obligation to scrutinize any transactions in which they are involved for potential conflicts and to disclose per the policy below.

For more information see the Objectivity in Research Policy

Application Sections

You will be asked to complete several numbered sections such as Subject Profile or Subject Population, Oversight and Monitoring, Recruitment, depending on the type of research you are doing.

If you have any questions about how to complete these sections call the Office of Research Subjects at 651-254-3391 for assistance.

 

CERTIFICATIONS & ASSURANCES

Signatures: 

The Principal Investigator MUST sign the application. The PI must also forward a copy to the head of their department.

 

 

Statements of Support:

Letters of support from all leaders accountable (financial and clinical) for any HealthPartners area affected by the study should be included. These signatures help assure the reviewers of your project that those who may be impacted by your work are aware of your plans.

 

LinkS to ApplicationS AND RESOURCES

 

Return to home page

 

Applications are due the 3rd Friday of the month; reviews will be completed by the 3rd week of the following month.  Send or bring the original application and 20 additional copies of the application, appendices and materials to:

 

HealthPartners Research Foundation

8170 Building

Mail Stop 21111R

 

Questions? Call 651-254-2928