Highlights from the Current Newsletter

The current issue features the MGHfC Digestive Disease Summer Research Program and research of Brett D. Nelson, MD, MPH, DTM&H; and Manasi Sinha, MD, MPH. Volume 7, Issue 1

Past issues are available in the Newsletter Archive.

Apply for SPR Young Investigator Coaching Program

The deadline for the Young Investigator's Coaching Program is rapidly approaching. Being a SPR member is NOT a criterion. The purpose of this program is to connect young pediatric faculty members to successful investigators in the appropriate research field, increasing opportunities for mentoring and networking for new researchers. Pediatric faculty members in the first 3 years of appointment who intend to pursue academic pediatric careers with a major component of investigator initiated research are encouraged to apply.

Deadline for applications is November 12. More information and the application can be obtained from the website's Funding Opportunities & Programs page.

Message from the Office for Interactions with Industry

About New Federal Requirements Affecting the Investigator Community

The Public Health Service recently issued new regulations governing financial conflicts of interest in Public Health Service-funded research that become effective on August 24, 2012. These new regulations impose some significant new requirements on the investigator community. While some of these new requirements are burdensome for investigators, they are final federal law, and so it is important for investigators to understand these requirements so that they can comply with them. Read more. (Word)


General Information

Responsible Conduct of Research: In accordance with NIH regulations, Partners offers a three part  RCR program.  These courses are mandatory for  recipients of NIH funding under a National Research Service Award, e.g., F32 or similar fellowship, or Mentored Clinical Scientist Development Award, i.e., K-series. The Partners program is available to all applicable trainees/fellows/investigators at BWH, MGH, McLean and Spaulding and consists of three segments.

All trainees/fellow/career awardees must provide documentation attesting to completion of the four courses within 12-months of attending a Partners specific seminar.  An RCR Attestation Form is provided to meet this requirement.

Research Disclosures: As previously announced, new federal regulations on financial conflicts of interest in research will go into effect this summer. The new regulations present important questions for many Partners individuals, including whether the new regulatory requirements apply to them, regardless of the source of their funding for their research. OII has posted FAQs on its website to address a number of these questions. You can find the FAQs and other information regarding the new rules at http://pulse.partners.org/OII/NIHhome.html.

Biostatistical Support from the Harvard Catalyst: The Harvard Catalyst program provides 4-6 hours of free biostatistical support to design clinical studies (including power calculations but not data analysis). Please contact Hang Lee, PhD, at hlee5@partners.org if you are planning grants that require this kind of statistical support.

Clinical Research Program

The MGH Clinical Research Program (CRP) can help with:

  • Preparing grant applications, including  (i) Biostatistical consultation on study design,  (ii) NIH budgets and referral to Corporate Sponsored Clinical Research for industry budgets, (iii) Investigator-initiated IND’s and Data Safety Monitoring Plans (DSMP), (iv) Coordination of the application process for large program project grants
  • IRB Submissions: work with PI from submission through IRB approval. $2500 flat fee and $2700 for pediatric studies
  • Providing experienced study coordinators ($41/hour)
  • Developing study databases
  • Identifying potential funding sources
  • Subject recruitment strategies

Contact Kay Ryan, Director, Clinical Research Operations, 617-726-3608 or kryan10@partners.org. Or visit us at Clinical Research Program

Clinical Research Education Unit Program for Clinical Research Staff: For course descriptions and registration please see: Current Offerings

Data Management Consultations Available to the MGH Clinical Research Community

Data Management Consultations are now available to the MGH clinical research community through the MGH Clinical Research Program (CRP).  Susan Regan, Ph.D., will provide the following consultation services:

  • Review protocol and data collection forms
  • Review existing or planned data entry system
  • Training in skills for day-to-day management of ongoing projects in Access databases
  • Report and query design
  • Integrating external sources of data (e.g. from laboratories, other sites)
  • Data export for analysis

For more information and to schedule a consultation, please fill out the request via http://www2.massgeneral.org/crp/mghstaff.html

MGH policy for use of controlled substances in non-human research

Many MGH Investigators regularly use controlled substances in their non-human research experiments.  Due to the potential for abuse of these agents, each investigator is responsible for procuring, securing, and monitoring controlled substances in accordance with applicable federal and state laws and hospital policy.  Investigators are also responsible for obtaining research-specific Massachusetts Department of Public Health and Federal DEA Registration Certificates and for ensuring that these registrations are updated and current. To assist you with understanding and implementing these regulations, a draft policy and procedure document (pdf) has been developed.

Updates from the Partners Human Research Office

Partners Human Research Office Bulletin

  • Conflict Of Interest Requirements Update Involving Study Staff Responsible For The Design, Conduct, Or Reporting Of The Research.
  • Clinical Trials Registration Requirements For Investigator–Initiated Clinical Trials Conducted By Partners Investigators.


Conflict of Interest Requirements Update

Since August 2007, the Partners Human Research Committee has required Principal Investigators (PI), Site Responsible Investigators (Site PI), and Co-investigators (Co-I) to complete the Investigator Disclosure Form when the research involves ANY of the following:

(1)   for-profit sponsor or funding source;

(2)   a marketed drug, device, or other technology, or a drug, device, or other technology in development;or

(3)   a new technology, software or therapeutic approach.

As of June 2011, the requirement for completion of Investigator Disclosure Forms has been extended to any member of the study staff responsible for the design, conduct, or reporting of the research. The eIRB forms for new protocols and study staff amendments now require the Principal Investigator to identifyany study staff person who, in addition to the PI, Site Responsible PI, or Co-I, has responsibility for the design, conduct, or reporting of the research. The PI should consider whether the tasks delegated to members of the study staff working under the direction of the investigators include responsibility for the design, conduct or reporting of the research.

The goal isnotto include every person working on the study, but rather to include those who have responsibility for the design, conduct or reporting of the research. Examples of persons on the study staff who wouldnotbe considered “responsible” include the following:

  • laboratory technicians performing assays and reporting them to the PI for analysis;
  • research assistants or coordinators responsible for scheduling appointments;
  • radiology technicians who provide the services for specific imaging; or
  • research nurses providing routine clinical care or administering standardized instruments/questionnaires.

IRB approval is contingent upon submission of Investigator Disclosure Forms for all applicable study staff, institutional review of positive disclosures and management of any identified conflicts of interest.

Questions about Conflicts of Interest should be directed to Maria Sundquist, Assistant Director, IRB at msundquist@partners.org; 617-424-4101. For more information, refer to the Partners Human Research Committee policy on Financial Conflicts of Interest. (pdf)

Clinical Trials Registration

As of 07/01/11, investigator–initiated clinical trials conducted by Partners investigators that meet FDA Amendments Act (FDAAA) clinical trials registration requirements must be registered on ClinicalTrials.gov prior to IRB approval.  The Clinical Trials Registration section of the eIRB forms for new and continuing review submissions now ask investigators conducting investigator-initiated clinical trials to provide the ClinicalTrials.gov registration number (e.g., NCT00000419) and to sign the designation of responsible party letter acknowledging responsibility for clinical trial registration and, if applicable, results and adverse event on ClinicalTrials.gov at the end of the study.

Additionally, FDA regulations 21 CFR 50 require the following language be included in the research consent forms of clinical trials registered on ClinicalTrials.gov:

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Website will include a summary of the results.  You can search this Web site at anytime.

For more information, see the Partners Clinical Trials Registration website.

Important note: Even if your investigator-initiated clinical trial does not meet the FDAAA clinical trials registration requirements, you are strongly advised to read the International Committee of Medical Journal Editors (ICMJE) clinical trials registration requirements and consider registering your clinical trial to comply with the ICMJE requirements for publication.  Your study may not be eligible for publication in some journals should you elect to not register.

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