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Information for Investigators

Publications
Funding for Ancillaries Fee Schedule

Recent Announcements:

4/12/12 Fee Schedule
6/7/08 CRC Dress Code Policy
3/12/08 Access to CRC Lab
9/19/07 Doctors Orders Review Process
8/16/06 CRC Standard Operating Procedures (SOPs)
3/30/04 Metabolism and Nutrition meal tickets on the CRC

Applying to Use the CRC     top

Welcome to the CRC. We hope that utilizing our facilities will enhance your clinical research.

About the HRC Resource Request Application

The HRC Resource Request Application is a web-based tool that allows investigators to submit requests for Harvard Catalyst-funded in- and outpatient resources. Investigators may apply for resources at one or more of the Catalyst Human Research Centers. 

After the application is submitted, the administrative, nursing, and Metabolic Phenotyping Core (bionutrition) staff at each institution where resources are requested review it to determine the feasibility and costs (if any) of conducting the study.  The application is then reviewed by two scientific reviewers selected from appropriate disciplines who evaluate the scientific merit of the study and, if necessary, assist in the prioritization of resources.

Please note that proposals for investigator-initiated studies, funded or unfunded and without previous peer review in NIH format, must include a letter from a biostatistician stating that s/he has reviewed the project and finds it acceptable. The Harvard Catalyst Biostatistics Consulting Service may be used for this. Please refer to this page for more information.

This application covers resource review and scientific review only. Institutional Review Board (IRB) review is a separate process, and is handled by the respective IRBs at each institution or through a ceded review process. IRB review may occur before, at the same time as, or after the scientific and resource review, depending on the institution(s) involved.

Access to this application requires an HMS eCommons ID. You may obtain one if you do not already have one by going to http://ecommons.med.harvard.edu/

How to submit a CRC Protocol:

Please go to the following link to submit a new protocol for review:

http://catalyst.harvard.edu/services/inoutpatientresources.html

Please also submit these documents / questions with your protocol submission:

  1. Doctors Orders: Please contact Faith Fortune (ffortune@partners.org) to obtain the Doctors’ Orders templates
  2. CRC New User Form
  3. Biosketch Template
  4. Medical Record Storage: Where would you like the Medical Records stored once the study has been completed? To Medical Records or to Retrievex (outside company)

Helpful Links for Investigators

General

Institutional Review Board (IRB) Submissions         top

The Partners Institutional Review Board (IRB) provides guidance conducting clinical research at Partners. Please go to http://healthcare.partners.org/phsirb/ for more information.


Publications      top

Please acknowledge the CRC grant as follows:

Grant Number: 8 UL1 TR000170-05
Harvard Clinical and Translational Science Center
National Center for Advancing Translational Science

Each publication, press release or other document that cites results from NIH grant-supported research must include an acknowledgement of NIH grant support and disclaimer such as "The project described was supported by Grant Number 1 UL1 RR025758-04, Harvard Clinical and Translational Science Center, from the National Center for Research Resources. For publications that included activity as of 5/1/12 or later, acknowledgement should indicate "The project described was supported by Grant Number 8 UL1 TR000170-05, Harvard Clinical and Translational Science Center, from the National Center for Advancing Translational Science".


The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health". If your study utilized GCRC resources (prior to 6/1/08), please use Grant Number M01-RR-01066. If your study utilized CRC resources (between 6/1/08 and 4/30/12), please use 1 UL1 RR025758.


Please use all Grant Numbers if appropriate. Please reference your PMID Number and PMCID Number on all publications / journals that you submit to the Clinical Research Center (CRC). These numbers are needed when we submit your publications for our Annual Report.

Fee Schedule (12/1/11 - 4/30/13)      top

Classifying your study as Investigator-initiated vs. Non Investigator-initiated:

The charges associated with studies on the CRC are determined, in part, by whether the submitted project is classified as investigator-initiated or non investigator-initiated. Investigator-initiated studies usually receive standard services from the CRC at no charge while non-investigator initiated studies are usually required to pay assigned costs.

Investigator-initiated studies are those that are planned and designed by an individual or groups of investigators independent of companies (“industry”).

Some investigator-initiated studies receive funding from industry, but are still considered to be investigator-initiated.

Non investigator-initiated (i.e. Industry-initiated, industry-sponsored) studies are usually initiated, designed and funded by industry (e.g. pharmaceutical company). The sponsor for the CRC program ( NIH National Center for Advancing Translational Sciences (NCATS)) requires that industry-initiated, industry-sponsored trials be charged based on costs.

Classifying your study during the application process:

In order to classify each project, investigators are required to submit an electronic application through the Harvard Catalyst Resource Request System, including IRB application form, IRB detailed protocol, sponsor protocol, protocol summary, itemized laboratory budget, summary statement, along with other relevant correspondence. These will aid the determination of the appropriate study category and what Harvard Catalyst funding should be awarded, if any. Please contact Faith Fortune, the CRC Administrative Coordinator at ffortune@partners.org, to obtain the application materials to use the CRC.

Fee Schedule:

Below is a brief summary of categories:

  • Investigator-initiated studies receive usually standard services free of charge.
  • Investigator-initiated studies that have industry funds will be asked to budget the study such that the industry sponsor supports these studies to the maximum extent possible.
  • Non-investigator initiated studies are required to pay assigned costs.

Upon request, Junior Investigators (e.g. first R01, K23 awardee or faculty rank of Assistant Professor or below) may be exempt from some or all of the fees (for example, for above-standard services).

We highly recommend that during the planning of your study, including the process of grant preparation, investigators consult with the Administrative Director, Nursing Director and/or the Metabolism & Nutrition Director to discuss specific funding questions or costs that should be included in your budget.

Please note that fees are subject to change. When constructing budgets, a 3% increase per year to cover any potential increases is recommended. We will notify investigators of any change as early as possible.

Please visit the Harvard Catalyst website at http://catalyst.harvard.edu/programs/hccrc/ for more information on the services that the Harvard Catalyst Clinical Research Centers (HCCRC) provides.

General Services:

 

Investigator-Initiated

 

Non Investigator-Initiated

 

Standard

Above Standard

 

Standard

Above standard

Television usage (local)

No charge

 

No charge

Phone

No charge

 

No charge

Parking

Investigator responsible

 

Investigator responsible

Laboratory tests**

 

Support provided*

Investigator responsible

 

Investigator responsible

Study Initiation – planning and implementation

Up to $1500

 

  • Up to $1500

 

* The MGH CRC supports investigator-initiated studies up to $60 average per visit for Junior Investigators (e.g. first R01, K23 awardee or faculty rank of Assistant Professor or below) or $30 average per visit for Senior Investigators. Investigator-initiated, industry funded studies may be eligible for this support as well.

** Laboratory costs are available using the MGH Clinical Research rate (for stat tests) or the LabCorp rate (for other routine tests) from the Administrative Director upon request. Please discuss with the Administrative Director if there are any questions.

 

Nursing:

 

Investigator-Initiated

 

Non Investigator-Initiated

 

Standard*

Above Standard*

 

Standard*

Above Standard*

Inpatient Bed day, includes standard supplies (IV catheters, tubing, solutions, etc.)**

No charge**

 

Investigator responsible

Supplies unique to study (LMX4, long IV lines, special aliquots, etc.) are supplied by investigator

Investigator responsible

 

Investigator responsible

Nursing services (includes OP space charge)**

No charge

$100/hour^

 

$100/hour^

Nurse Practitioner (includes OP space charge)***

No charge

$125/hour^

 

$125/hour^

*Please contact the Nursing Director to discuss charges for above standard nursing services or Nurse Practitioner time for your study. For more intensive nursing services than provided by standard inpatient services, contact the Nursing Director.

**Current rate (10/1/11-9/30/12) = $1200.42/day Room and Board (standard services, including standard meals and basic nutrition counseling); Contact CRC Administrative Director for Room and Board fees for specialized units for inpatient scatter-bed days. Rate is in effect for MGH fiscal year (Oct 1 st through Sept 30 th.)

***For specific information on charging above standard Nursing Services or Nurse Practitioner time for your study, please contact the Nursing Director. For more intensive nursing services than provided by standard inpatient services, contact Nursing Director.

^ 1 hour minimum and then by ¼ hour: (studies requiring specialized intensive prolonged services, or minimal use, contact Nursing Director)

 

  Metabolism and Nutrition Research (MNR):

 

Investigator-Initiated

 

Non Investigator-Initiated

 

Standard

Above Standard

 

Standard

Above Standard

Anthropometric assessments

No charge

 

 

Height/weight: no charge; other measurements, $75/hour^

Bioelectrical impedance analysis (BIA)

No charge

 

 

$18.75/assessment

 

DXA*

$35/scan up to $105 max/visit

Specialized scans

 

$52.50/scan up to $157.50

 

Exercise testing

$100/session

 

$150/session

Food record analysis and data report

No charge

 

$75/food record (i.e. 3-4 days)

Indirect calorimetry (energy expenditure)

Single Measurement No charge

> 1 measurement/hr

$50/hour^

 

$75 per hour^

 

Nutrition counseling

≤ 20 minutes/visit

No charge

> 20 minutes/visit

$50/hour^

 

$75/hour^

Administer questionnaire and data report

No charge

 

 

$75/hour^

 

Standard

Above Standard

 

Standard

Above Standard

Meal ticket

Investigator responsibility

 

Investigator responsibility

Snack

 

 

 

Inpatient

No charge

 

$3.00 snack

Outpatient**

(fasting or up to 4 hrs)

No charge

 

 

$3.00 snack

Meal: Routine

 

 

 

Inpatient (included in room charge)

No charge

 

$5.00 breakfast

$8.50 lunch or dinner

Outpatient ( ≥ 4 hours)

No charge

 

 

$5.00 breakfast

$8.50 lunch or dinner

Meal: Weighed***

 

 

 

Inpatient

$45-$75 per day

 

$60-$100 per day

Outpatient

$45-$75 per day

 

$60-$100 per day

*DXAFees as of 5/1/2013: $45/scan; $135 maximum for standard scans per visit. Standard scans include forearm, hip, AP lateral, lumbar spine for bone mineral density and whole body for body composition. Examples of non-standard scans include hip structural analysis, distal femur scan, etc. For specialized scans, contact the Metabolism & Nutrition Research Director.

** Outpatient snack only provided for fasting or up to 4 hours; single blood draw only visits do not have a snack provided.

*** For specific information on fees, please contact the Metabolism & Nutrition Research Director . For other items not listed here, see MNR Director.

^1 hour minimum and then by ¼ hour: (studies requiring specialized intensive prolonged services, or minimal use, contact Metabolism & Nutrition Director )

 

Biomedical Imaging Core