Institutional Review Board (IRB)

PROTOCOLS SUBMITTED WITHOUT ALL THE REQUIRED DOCUMENTATION WILL NOT BE REVIEWED

** Starting on Monday, May 3, 2021 all protocols sent back with Specific Minor Revision or Substantive Revision have up to three months to answer and send back through Streamlyne. If the investigator does not reply to the critiques, the protocol will be eliminated from the system.

All investigators must obtain IRB approval for research protocols involving human subjects before initiating the study. All submissions must be electronically submitted thru STREAMLYNE and the response to questions must be in English.

STREAMLYNE is an efficient online system for faster review and online approval. The primary objective of the implementation of Streamlyne at PMSF is to remove the paper processing related to Research Administration Compliance. We kindly recommend reading the guidelines carefully, answer all of the IRB questions directly related to the protocol needs and save your responses frequently.

➢ Personnel section (CITI Certificates uploads must be in PDF format). Training certificates are valid for three years. For more information see CITI Program Certificates

✓ Human Subjects Research (Biomedical, Social and Behavioral or Public Health)
✓ IPS (HIPAA) – Information Privacy Security
✓ Good Clinical Practice

➢ Notes & Attachments (additional information) -must be submitted both in English and in Spanish. (ONE SINGLE PDF file)
▪ Abstract – (Specific Aims, Research Strategy)
▪ Consent forms – (must be written in simple language at an 8th-grade reading level (if applicable English and Spanish)
▪ Assent form (if applicable – English and Spanish) – for research involving children under the age of 21 years old.

▪ Supplemental material (must be written in simple language at an 8th-grade reading level)
✓ Questionnaires/Surveys
✓ Interviews
✓ Posters
✓ Flyers/Advertisements

▪ Biohazard approval letter (all protocols dealing with human sample collection and processing) – English
▪ Authorization letters (If the recruitment of subjects will take place in a school, hospital, or another place, the investigator needs to request authorization from the research site)

**ALL FILES MUST BE SUBMITTED IN A SINGLE PDF FILE and this specific order or it will be returned to PI.

*Please note the difference between anonymity and confidentiality. An anonymous study does not collect any information that may identify the human subject. If personal information is to be collected, then appropriate measures to protect the privacy and assume confidentiality of the data must be explained.*

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