Partners Human Research Committee

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Brigham and Women’s Hospital Resources

Institutional Research Assistance

IRB: Partners Human Research Committee

The Partners Human Research Committee (Institutional Review Board) ensures all research being conducted at the Partners Institutions comply with all necessary legal and ethical guidelines. The Partners IRB provide support and training on the new eIRB and other requirements.

Homepage: http://healthcare.partners.org/phsirb/

Policies: http://healthcare.partners.org/phsirb/guidance.htm

617-424-4100

Partners Human Research Quality Improvement Program

Partners Human Research Quality Improvement Program is committed to providing ongoing support and education to the research community. The staff conducts routine onsite reviews, audit preparation, and educational QI In-services to ensure clinical research compliance.

Website: www.partners.org/phsqi/

Partners Clinical Research Office (PCRO)

The PCRO provides Budgets and Contract support, as well as information to help set up fund numbers.

Location: 101 Huntington Avenue, 4 th Floor, Boston, MA 02199

Contact: Maureen Lawton, Interim Director

Email: mlawton@partners.org

617-954-9367

BWH Research Compliance

The Research Compliance office provides general support to help ensure the quality and integrity of research across the institution as well as assists investigators with understanding regulatory requirements. www.bwhbri.partners.org/research_compliance

Contact: Allison Moriarty, Director

Email: apmoriarty@partners.org

617-732-8335

Research Billing Compliance assists researchers to ensure research-related patient care charges are processed appropriately. In addition, Research Billing Compliance will also help decipher Partners Invoice Statements, reconciliation of grant(s), and education/training fees.

Contact: Sonya Huggins

Email: shuggins@partners.org

617-732-8337

If you are concerned about the appropriateness of a specific activity, decision or action, call the anonymous and confidential Partners Compliance Helpline at 1-800-856-1983, or go to www.partners.org/complianceline.

BWH Finance and Revenue Operations

The Finance and Accounting Office assists with concerns relating to research patient care charges that were inappropriately billed to insurance.

Contact: Deborah A. Goodman, Sr. Project Manager

Email: dagoodman@partners.org

Lab Certification

This office provides certification for laboratory use for clinical trials (CLIA certification) and provides information regarding normal laboratory levels for Brigham and Women’s

Hospital.

Contact: Cecilia Robinson

Email: crobinson2@partners.org

617-732-6245

Investigational Drug Service (Pharmacy)

The Investigational Drug Service (IDS) offers pharmaceutical services and guidance to support research activities for all research groups and investigators engaged in research.

The IDS ensures the delivery of high quality pharmaceutical care by adhering to all laws and regulations while minimizing the risks associated with participation in an investigational drug trial.

Contact: Tricia Kelly

Email: pkelly8@partners.org

617-732-6410

Research Training

Clinical Trial Registration

ClinicalTrials.gov

is a directory of federally and privately supported research trials conducted in the United States and around the world. Registration at www.clinicaltrails.gov

is mandated by law (PRS and US Public Law 110-85). The

International Committee of Medical Journal Editors (ICMJE) also requires registration as a condition for publication of research results generated by a clinical trial (N Engl J Med

2004; 351: 1250-1).

For further details, please refer to Partners IRB website regarding Clinical Trials

Registration at: www.healthcare.partners.org/phsirb/ct.gov.htm

Contact:

Sarah White

Email: swhite12@partners.org

617-424-4137

CITI Training

Victoria Mirabello

Email: vmirabello@partners.org

617-424-4140

The Collaborative Institutional Training Initiative (CITI) program was developed by experts in the "IRB community". Researchers and staff from the BWH/FH/MGH clinical research community are required to complete an initial CITI certification and CITI recertification is required every three years. www.citiprogram.org

Contact: Victoria Mirabello

Email: vmirabello@partners.org

617-424-4140

Infection Control

Infection Control is responsible for establishing procedures necessary to maintain infection control guidelines that are consistent with city, state, and federal health regulations. Infection Control can assist investigators to ensure their protocols adhere with safety regulations.

617-732-6785

Hazardous Material Training

The Hospital’s Hazardous Material department provides annual training for those who ship samples. In addition, the Hazardous Material department provides emergency planning and training for the Hospital.

Contact: Casey Lucas

Email: cmlucas@partners.org

617-525-7341

Percipio Access/Training

Through Precipio, investigators can access ancillary service requests for departments such as Radiology, Endoscopy, and Cardiology. This department can provide access and training to successfully use Percipio.

Contact: BWH Help Desk at 617-732-5927

Insight Access/Training

Insight is a website developed for the Partners research community to aid investigators and administrators in retrieving grant, contract, protocol and financial data pertaining to an investigator’s research portfolio.

Contact: Susan Howard, Team Lead insighthelpdesk@partners.org

617-424-4175

Funding Opportunities

To receive weekly emails regarding funding, sign up for the Friday Funding

Opportunities , maintained through Research Administration. http://bwhbri.partners.org/ResearchAdmin/Grants/RICSFundingOpps.asp

Recruitment Resources

There are multiple resources for recruiting participants for clinical trials. To get started, it is important to first read through the IRB Guidelines for advertising, which can be found at http://healthcare.partners.org/phsirb/recruit.htm

Investigators can advertise their clinical trials on the central Partners website : www.clinicaltrials.partners.org

or investigators can access potential participants through

RSVP for Health , a database onto which interested volunteers may sign to become involved in research studies: www.rsvpforhealth.partners.org/researchers.asp

Investigators can also use the Research Patient Data Registry (RPDR) to access study populations. RPDR can query medical records for specific diagnoses, inpatient procedures, provider type data, wet laboratory results, discharge summaries, radiology and pathology reports, and operative notes. With IRB approval, researchers may access specific patient records: http://rpdrweb/partners/rpdrinfo/start/Newbrowser.htm

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