UMass researchers working with collaborators at Baystate may now be eligible to seek IRB review at Baystate only, thereby avoiding the requirement for both UMASS and Baystate IRB review. The following guidance is intended to help researchers determine whether their research is eligible for such review. Eligible research includes collaborative human research studies where the source of the subjects, data, or specimens is Baystate. The research itself may occur at either or both campuses.
Studies NOT eligible for review at Baystate include:
- Research using human tissue or body fluids where labs have not been cleared through EH&S Biosafety procedures. Please contact Judy LaDuc for more information (577-7293).
- Collaborative research involving more than UMASS Amherst and Baystate researchers.
- Where there is a potential conflict of interest (COI) that has not been cleared through the UMass COI Committee. Please use the following grid to determine this:
If you have answered YES to any of the following questions, please submit your COI disclosure materials to the Human Research Protection Office (HRPO) prior to your application to Baystate.
- Do any of the involved investigators or their immediate family (as described below) have consulting arrangements, management responsibilities or equity holdings in the Sponsoring company, vendor(s), provider(s) of goods, or subcontractor(s)?
- Do any investigators or their immediate family have any financial relationship with the Sponsoring company, including the receipt of honoraria, income, or stock/stock options as payment?
- Is any Investigator(s) a member of an advisory board with the Sponsoring company?
- Do any investigators receive gift funds from the Sponsoring company?
- Do any investigators or their immediate family have an ownership or royalty interest in any intellectual property utilized in this protocol? ("Immediate family" means a spouse, dependent children as defined by the IRS, or a domestic partner.)
Registration: The research must be registered with the UMass Human Research Protection Office (HRPO) prior to application to the Baystate IRB using this registration form. The initial IRBNet application to the Baystate IRB will require an electronic signature from the UMass HRPO. This will serve as the verification to Baystate that the project has been registered with the UMass HRPO.
Principal Investigator: A Baystate Principal Investigator must be named on the Baystate IRB application, while the grant or study-wide Principal Investigator may be from either UMass or Baystate. UMass researchers registering must hold faculty level position.*
Ethics Training and Research Personnel: Individuals who directly interact with subjects or their identifiable data must be listed on the application to the Baystate IRB and have current (within the past 3 years) Baystate training in the protection of human subjects (CITI or approved substitute). UMass personnel can identify Baystate as a secondary affiliation on the CITI website to gain access to the Baystate-required modules. There is overlap between the institutions requirements, the secondary affiliation feature “credits” the researcher for the modules already completed for UMass.
Access to Baystate Facilities and Records: Research personnel from UMass who will be assisting in the conduct of research at a Baystate facility can gain the necessary clearance and access to Baystate systems through the “Associates in Research” process. Associates in Research are processed through the Academic Affairs Allied Health Office. See below for contact information.
Grant Application: When a project is funded, the grant application must be included in the submission to the Baystate IRB so that the IRB can fulfill it's duty to verify that the research proposed to the IRB is consistent with the research as described to the grantor.
ClinicalTrials.Gov: When registration on ClinicalTrials.Gov is required, the study-wide Principal Investigator holds responsibility for ensuring that registration, interim updates, and reporting of results takes place. The Baystate IRB Application Part 1 contains information on the ICJME and FDA guidelines to help investigators determine whether or not their study must be registered.
Event Reporting: When UMass is the recipient of grant or other funds to support the project, both the Baystate IRB and the UMass HRPO must be informed of any unanticipated problems, noncompliance, or suspension or termination of the research. Baystate and UMass will collaborate on any required reporting to the grantor and applicable federal and state agencies.
Repositories:When data or specimens will be retained for future research projects at UMass the repository must be approved by the UMass IRB and documentation of the repository approval included in the Baystate application. Subjects should be consented separately for the banking of their specimens or data for future research; this should not be a condition of participation in the primary research project.
Policies: The policies and guidance documents of the Baystate HRPP must be adhered to including allowing access at reasonable times and with reasonable notice for routine and for-cause quality assurance monitoring. The policies of the Baystate HRPP can be accessed internally on eWorkplace or externally on BaystateHealth.org.
*(Students' projects must be submitted by faculty sponsor).
|Baystate||University of Massachusetts|
Jennifer Pacheco, BS, CIM, CIP
Director: Human Research Protection Program
Phone: (413) 794-3458
Human Research Protection Office (HRPO)
Phone: (413) 545-3428
Glenn Markenson, MD
Medical Director HRPP
Phone: (413) 794-3470
Vice Chancellor Michael F. Malone, PhD
Institutional Official, VC for Research and Engagement
Phone: (413) 545-5270
Matthew Richardson, MD
Chair: IRB #1
Phone: (413) 794-9338
Lynnette Leidy Sievert, PhD
Chair: UMass Amherst IRB
Phone: (413) 545-1379
Robert Baevsky, MD
Chair: IRB #2
Phone: (413) 794-4159
Manager: Biological Safety Services, EHS
Phone: (413) 545-7293
|HRPP/IRB Main Office: (413) 794-4356||HRPO/IRB Main Office: (413) 545-3428|