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, as well as the checklist) need to be submitted to:

Karen Helfer, Ph.D.
Chair, SPHHS-HSRC
358 N. Pleasant St. Room 201B
(413) 545-4014  
khelfer@comdis.umass.edu

Click here to download the HSR Checklist, which will need to be submitted with your materials.

Please expect the review to take 2 to 4 weeks, although many are reviewed much quicker. Feel free to contact Karen Helfer 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/forms/form-441).
• Abstract.  Supply a 1-page summary of the study’s purpose and research methods
• Certificates of appropriate human subjects training for the Principal Investigator and all key personnel. Certificates can be found at http://www.umass.edu/research/human-subjects-trainingciti-training-course.
• Informed Consent document. This document should be written in simple, straightforward language aimed at about an 8^th-grade reading level. Avoid jargon and define all technical terms. Instructions and templates for Informed Consent documents can be found at http://www.umass.edu/research/forms/informed-consent-instructions and http://www.umass.edu/research/consent-form-template . Please substitute, “SPHHS Local Human Subjects Review Board” for “UMass IRB” in the sentence on the template indicating that the protocol has been approved (you may retain the general UMass contact information). Depending on your research project, you also may need to include an Informed Consent Cover Letter for Survey and/or Assent Samples (for children ages 7 to 17).
• Supporting documentation. Include copies of all questionnaires and survey instruments that will be used in your study.
• Recruitment materials. Supply a one-paragraph description of recruitment procedures along with copies of advertisements and flyers that will be used to identify participants.
• Please include contact information (phone, email & office addresses) of all PIs, including student investigators and faculty advisors.