MGH CRC Fee Schedule 12/1/11 - 4/30/13 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. Investigatorinitiated studies usually receive standard services from the CRC at no charge while noninvestigator 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: The fee schedule is found on pages 2-3. 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. Final April 13, 2012 Page 1 of 3 MGH CRC Fee Schedule 12/1/11 - 4/30/13 General Services: Investigator-Initiated Standard Television usage (local) Phone Parking Laboratory tests** Study Initiation – planning and implementation Above Standard No charge No charge Investigator responsible Support Investigator provided* responsible Up to $1500 Non Investigator-Initiated Standard Above standard No charge No charge Investigator responsible Investigator responsible 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 Standard* Above Standard* No charge** Non Investigator-Initiated Standard* Above Standard* Investigator responsible Inpatient Bed day, includes standard supplies (IV catheters, tubing, solutions, etc.)** Supplies unique to study Investigator responsible Investigator responsible (LMX4, long IV lines, special aliquots, etc.) are supplied by investigator Nursing services (includes No charge $100/hour^ $100/hour^ OP space charge)** Nurse Practitioner No charge $125/hour^ $125/hour^ (includes OP space charge)*** *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 1st through Sept 30th.) ***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) Final April 13, 2012 Page 2 of 3 MGH CRC Fee Schedule 12/1/11 - 4/30/13 Metabolism and Nutrition Research (MNR): Investigator-Initiated Standard Anthropometric assessments Bioelectrical impedance analysis (BIA) DXA* Exercise testing Food record analysis and data report Indirect calorimetry (energy expenditure) Nutrition counseling Administer questionnaire and data report Meal ticket Snack Inpatient Outpatient** (fasting or up to 4 hrs) Meal: Routine Inpatient (included in room charge) Outpatient (≥ 4 hours) Meal: Weighed*** Inpatient Outpatient Above Standard No charge No charge $35/scan up Specialized scans to $105 max/visit $100/session No charge Single > 1 measurement/hr Measurement $50/hour^ No charge ≤ 20 > 20 minutes/visit minutes/visit $50/hour^ No charge No charge Standard Above Standard Investigator responsibility Non Investigator-Initiated Standard Above Standard Height/weight: no charge; other measurements, $75/hour^ $18.75/assessment $52.50/scan up to $157.50 $150/session $75/food record (i.e. 3-4 days) $75 per hour^ $75/hour^ $75/hour^ Standard Above Standard Investigator responsibility No charge No charge $3.00 snack $3.00 snack No charge $5.00 breakfast $8.50 lunch or dinner $5.00 breakfast $8.50 lunch or dinner No charge $45-$75 per day $45-$75 per day $60-$100 per day $60-$100 per day *DXA Fees 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) Final April 13, 2012 Page 3 of 3