RESEARCH TIPS

This column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research. 

Did you know?

• Baystate Medical Center is a member of the Tufts Clinical and Translational Science Institute, which is a participant of the Clinical & Translational Science Award (CTSA) sponsored by the National Institutes of Health.




• ResearchMatch recruitment for research participants has begun. See researchmatch.org to sign up.




• HRPP & IRB SOP’s are posted on eWorkplace at Departments > Academic Affairs > Academic Affairs Policies > Research Policies > HRPP & IRB policies




• Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.




• A minor change is one which, in the judgment of the IRB reviewer, makes no substantial alteration in:

  • the level of risks to subjects

  • the research design or methodology (adding procedures that are not eligible for expedited review would not be considered a minor change

  • the number of subjects enrolled in the research (no greater than 10% of the total requested)

  • the qualifications of the research team

  • the facilities available to support safe conduct of the research

  • any other factor which would warrant review of the proposed changes by the convened IRB

Additional Resources

For additional information, contact the Human Research Protection Program at (413) 794-4356.