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The GCRC Application for UseGCRC Application for Use
Application and Submission Dates
Data Safety and Monitoring Plan
Criteria for Principal Investigators
GCRC Application Approval Process
Responsibilities of the Principal Investigators
Funding
Protocol Start Up Meeting
Change of Research Protocol
Termination of the Protocol
Signature
The GCRC Application for Use requests information specific to the implementation of your project in the GCRC. The IRB application contains the scientific and clinical information on the project. Both of these documents are the core of the request that is considered by the Advisory Committee when you request to use our services.
The GCRC application packet is available herein or by calling Courtney Alpert at 638-4544. Please read investigator essentials for information on: application, submission, Data Safety and Monitoring Plan, responsibilities, and publications before proceeding.
The INSPIR IRB application is available online. IRB approval IS NOT required prior to submission to the GCRC. All studies must, however, have IRB approval prior to initiation in the GCRC. To be accepted for review by the GCRC, the IRB application status must be stamped "SUBMITTED" at the top left-hand corner of the application front page. IRB applications with any other designation (draft, awaiting signature, etc.) will not be accepted for review.
It is recommended that investigators complete the IRB and GCRC applications simultaneously.
Please note that the IRB requires “sign-off” by the GCRC Research Subject Advocate prior to IRB acceptance of the study for their review. This sign off is not acceptance to use the GCRC. The Advisory Committee will meet and review applications for use.
Suggested Sequence:
1) GCRC signature by the Research Subject Advocate as part of the IRB application
2) Complete IRB application and submit to IRB Office. The IRB application MUST have a Status: SUBMITTED before it comes to the GCRC.
3) Complete GCRC application and deliver all components on the checklist to the GCRC Office. Electronic copies are not accepted.
Application and Submission Dates
The Application and Instructions
The application on this website is meant to be completed on your own computer. Please note: Two collated copies of the application is to be delivered to Courtney Alpert, Fuller Building 9th Floor, Suite 900. Emailed applications are not accepted. Submission items are listed below.
The Submission Consists of:
- GCRC Application (Signed Original & 2 Copies)
- DSMP Plan (contact Mary-Tara Roth, RN, MSN, MPH) (2 copies)
- IRB Materials
Application (marked "submitted" with detailed protocol - 2 Copies Consent/Assent Forms - 2 Copies HIPAA Authorization Form (if not included in Consent Form) - 2 Copies IRB Letter of Approval - 2 copies - Industry Protocol (if applicable) – 5 Copies
Sponsor Protocol Investigator Drug Brochure - NIH Educational Program Certificates for all listed personnel - 2 Copies
- Conflict of Interest Disclosure Form for P.I. only - 2 Copies
- Signed Checklist
Submission Dates
Applications are accepted at any time. The 2008-2009 submission dates are as follows:
- June 25, 2008
- August 27, 2008
- October 29, 2008
- December 18, 2008
- February 25, 2009
- April 29, 2009
- June 24, 2009
- August 26, 2009
- October 21, 2009
Two collated copies of the application materials are to be delivered to Courtney Alpert, Fuller 9th floor, Room 900.
The Advisory Committee meets six times a year to review applications. The Committee’s reviews will be sent to the project Principal Investigator. The PI must respond in writing to each of the questions and comments of the Committee. Reviewers may require changes to protocols.
Data Safety and Monitoring Plan (DSMP)
Per guidelines approved November 18, 2002, the NIH requires all GCRC protocols to have a Data and Safety Monitoring Plan (DSMP) approved by the GCRC Advisory Committee (GAC) prior to initiation of the protocol.
In order to assist all investigators submitting an application to use the GCRC, we have developed an automated tool to build your project-specific DSMP.
Each plan will be unique based on the nature, size, complexity, and the degree of risk for the individual research protocol. Depending on the level of risk of your study, the GAC may require an independent monitor or the formation of a Data and Safety Monitoring Board (DSMB).
Please contact the Research Subject Advocate (RSA) of the GCRC with any questions you may have.
Criteria for Principal Investigator
In order to submit an application the Principal Investigator (PI) of the project must meet these qualifications:
Eligible:
· Investigator appropriate for the study and member of the host institution (physician, nurse, pharmacist, social scientist, PhD, etc)
· If physician, the individual must be a member of the BUMC/BMC medical staff
Ineligible:
· Physicians in training e.g. interns, residents, fellows (except those with staff privileges)
General Medical/ Dental Coverage
· Advisory Committee may require physician with appropriate expertise substantively involved
· Physician of record must have admitting privileges
· If study or procedures are more than minimal risk investigators must have demonstrated expertise consistent with delineation of privileges
Principal Investigator of Record
· Principal Investigator on IRB, GCRC application and informed consent must be the same
GCRC Application Approval Process
Prior to submission to the IRB, the Research Subject Advocate will review the application for the GCRC. This review will answer safety, data monitoring, and HIPAA requirements. Review at this stage does not indicate the study can use the GCRC. The protocol must then be submitted to the GCRC Administrative Office for review by the GCRC Advisory Committee.
The Advisory Committee acts as a Board of Directors and has the responsibility for review, approval, and oversight of all GCRC activities. The chairman of the committee is Aram Chobanian, MD, President Emeritus. The committee meets bimonthly to evaluate proposals based upon scientific merit and need for center resources. The committee is responsible for the designation of the category of inpatient days and outpatient visits for each research project proposed and set a priority score.
The GCRC Administrative Director assigns a primary, secondary, statistical, and subject advocate reviewer. The reviewer critiques the study verbally and in a written report at the Advisory Committee meeting.
If the Committee approves the protocol as submitted, the investigator is eligible to use GCRC resources assuming the IRB approval has been granted. If the study is not approved as submitted, suggestions for revision are sent in a letter from the Program Director, Michael Holick, PhD, MD within 3 business days of the GCRC Advisory Committee Meeting. Investigator responses should be addressed to Dr. Holick, Program Director, and sent to Courtney Alpert. The Program Director is responsible for the final approval to start the study. A deferred protocol returns to the full Advisory Committee. The protocol will be returned to the investigator with specific suggestions for revision.
A protocol can be reviewed simultaneously by the IRB and the Advisory Committee. The study cannot accrue patients on the GCRC until it has been approved by the IRB.
Responsibilities of the Principal Investigator
A) Provisions of Medical/ Dental Care of GCRC Participants
Each investigator is responsible for the care of patients under his or her project either personally or through designated co-investigators, fellows, or residents.
Arrangements for emergency and night care must be formalized.
B) Informed Consent
No patient is seen unless there is a valid informed consent and HIPAA authorization available to the nursing staff prior to initiation of the study. It is the responsibility of the investigator to present this to each subject to the appropriate GCRC nurse/ dental hygienist.
C) Industry Initiated Project
These projects utilize the services of the GCRC and any charges incurred. All charges are paid directly by the sponsor through the responsible investigator. The investigator is billed directly and the bill is reviewed by the investigator. The payment is made after 15 business days by a transfer of funds from the investigators industry account to the GCRC grant.
D) Certifications in Protection of Human Subjects Research
At the time of application, all persons listed in the GCRC and IRB application must be NIH Certified. As Principal Investigator, you assure that all current and future individuals involved in the design and conduct of this project are and will remain certified per NIH regulation.
BUSM holds regular certification courses. Course dates are available from Office of Clinical Research at 414-1330. In addition, certification can be done online at (website)
E) Conflict of Interest Disclosure:
Financial conflict of interest may introduce biases that compromises the results of research. It is the responsibility of the Principal Investigator of each project to submit the BUMC conflict of interest form as part of the application on the project to be done in the GCRC. Only the Principal Investigator’s Conflict of Interest form is required by the GCRC. The investigator is responsible for submission of his forms and that of his staff to the Office of Research Administration at BUSM.
F) Research Progress Reports:
An annual report must be prepared by the GCRC in accordance with instructions from NIH. You are part of this report. Continued use of the GCRC is contingent upon meeting this annual report requirement, as NIH funding to the Center maybe reduced or eliminated if the GCRC-based investigators do not comply with this requirement for annual progress information.
Accumulation of the material necessary for this report is the responsibility of the Administrative Director. The report is based on progress reports, census, publications of Investigators utilizing the Center, and research support to BUMC investigators. Annually, all investigators will be asked to contribute information about the status of their study, please respond in a timely manner. Each year some investigators will be chosen to provide a brief abstract of data gathered in the GCRC and already published in journals for inclusion in the progress report.
G) Research Support:
Data from all investigators on the amount of sponsored research support, from all funding sources, they or a co-investigator of the project receive is a required part of the annual progress report. Your funding information will be obtained directly from cognizant institutional officials at BUMC and BUSM.
H) Publications
Continued funding of the GCRC is dependent on our publication record.
Publications arising from research projects involving the use of GCRC resources must acknowledge this support by stating, “Supported by grant M01- RR00533 from the General Clinical Research Centers Program of the National Center for Research Resources, National Institutes of Health”.
Continued use of the GCRC is contingent upon meeting this requirement, as NIH funding to the Center maybe reduced or eliminated if the GCRC-based investigators do not comply with this agreement.
The grant supports inpatient and outpatient services and the cost of diagnostic laboratory tests such as CBC’s, x-rays etc. The level of funding to each principal investigator per protocol depends on the Advisory Committee’s review of the application and availability of grant funds. NIH guidelines require that industry sponsored studies incur a charge to the investigator to use the Center. To ensure research diversity, no single group of investigators may utilize more than 33 percent of resources.
Protocol Start-Up Meeting
Prior to initiation of a study, the Principal Investigator and his/her staff must meet with the Nurse Manager, Bionutrition Manager, Core Lab Director, Administrative Director, and Research Subject Advocate to review the study. The meeting lasts about 45 minutes, and assures that all documentation has been received and appropriate resources identified. The start-up meeting should occur at least two weeks prior to entry of the first patient. Subsequent meetings between the investigators, his/her staff, and GCRC clinical staff may be needed to properly initiate the study.
This meeting is scheduled by contacting Courtney Alpert. She will coordinate the date and time with a member of your staff.
If a protocol is substantially modified, an amendment must be submitted and approved by the IRB before patients can be enrolled in the revised protocol. The Principal Investigator is responsible for notifying the GCRC nursing staff of all amendments and should provide an updated informal consent. In addition, some revisions may require an additional review by the Advisory Committee upon request. In this case, the investigator should submit copies of the amendment to the Advisory Committee.
The protocol will terminate if one or more of the following conditions are met.
1. Principal Investigator notifies Advisory Committee
2. The protocol has not been annually reviewed and approved by the Committee on Human Subjects each year.
3. No patients are enrolled for a period of 12 consecutive months.
4. The GCRC is instructed by Advisory Committee, the Food and Drug Administration, or the Committee on Human Studies to terminate the protocol, or
5. Agreed-upon industry funding from the investigators to the GCRC is not forthcoming.
Your signature on the GCRC application face page assures responsibility for and compliance with the items in For Investigators.
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INSPIR
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| ADMINISTRATIVE OFFICE Janice Kopp Administrative Director Ph: (617) 638-4542 Fax: (617) 638-8890 Email: jkopp@bu.edu
Courtney Alpert Administrative Coordinator Ph: (617) 638-4544 Fax: (617) 638-8890 Email: alpertc@bu.edu |
RESEARCH SUBJECT ADVOCATE Mary-Tara Roth, RN, MSN, MPH |
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