SPHHS Local Human Subjects Review Board
Information Required with Each Protocol Submission
Research studies conducted by students and faculty within the SPHHS for human studies that are not funded through external grants and that pose minimal risk to the subjects involved may be reviewed by the “local” (SPHHS) Human Subjects Review Committee, rather than at the University level. Although the University Human Subjects Committee has transitioned to online submissions, the SPHHS Committee has not, so TWO hard copies of all documents (listed below) need to be submitted to:
Alayne Ronnenberg, ScD, Chair, SPHHS-HSRC
211 Chenoweth Lab
545-1076 alayne.ronnenberg@gmail.com
Please expect the review to take 2 to 4 weeks, although many are reviewed much quicker. Feel free to contact Dr. Ronnenberg with questions about your submission.
If you are submitting more than 1 protocol at the same time, please be sure that each protocol is complete by itself, submitted in duplicate and that the materials for each protocol are clipped together to avoid confusion.
Documents to be submitted:
- Completed form 441 (Available at: http://www.umass.edu/research/comply/localreviewboards.html)
- Abstract: 1 page or so describing the study purpose and research methods
- Certificates of appropriate human subjects training for principal investigator (PI) and all key personnel are available at http://www.umass.edu/research/comply/citi.html. Personnel should complete additional CITI training modules if they are planning to work with vulnerable populations, such as pregnant women, children, etc.
- Informed Consent Document:
- The informed consent document should be written in simple, straightforward language aimed at about the eighth-grade level. Please try to avoid jargon and to define all technical terms that you feel must be included
- Instructions for completing the informed consent form and various informed consent templates, depending on the nature of the study, are available at:
- Please delete the sentence in the template indicating that the protocol has been approved by the UMass IRB, although you may retain the UMass contact information.
- "Informed Consent" Cover Letter for Survey
- Assent Samples (for children ages 7 to 17)
- Supporting documentation (questionnaires, survey instruments, etc.)
- Recruitment Materials (recruitment procedures and copies of advertisements and flyers)
- Please include contact information (phone, email & office addresses) of all PIs, including student investigators and faculty advisors.
