PROTOCOLS SUBMITTED WITHOUT ALL THE REQUIRED DOCUMENTATION WILL NOT BE REVIEWED
All investigators must obtain IRB approval for research protocols involving human subjects prior to 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.
Login to Streamlyne
Go to https://research.ponce.streamlyne.org
PHSU employees can login with their username and password.
**If you do not have a Streamlyne account, complete this form to request an account: http://j.mp/2Atz5pC **
➢ Personnel section (CITI Certificates uploads must be in PDF format)▪ Certificates of Human Subjects training and Research Aspects of HIPAA -CITI Program (citiprogram.org) for all personnel involved in the research. Training certificates are valid for three years.
✓ Human Subjects Basic Refresh (Biomedical, Behavioral or Public Health)
✓ IPS – Information Privacy Security
✓ Good Clinical Practice (PI’s & Co-PI’s)
➢ One Attachment (with the following information) -must be submitted both in English and in Spanish. (PDF file)
▪ Abstract – English (Specific Aims, Research Strategy)
▪ Consent forms – (must be written in simple language at an 8th grade reading level (English and Spanish)
▪ Assent form (if applicable- English and Spanish) – for research involving children 20 years old or younger
▪ Supplemental material (must be written in simple language at an 8th grade reading level) – English and Spanish
- 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 other place, the investigator needs to request an authorization from the research site)
*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.*
PHSU-PRI is affiliated with the “Collaborative Institutional Training Initiative (CITI Program) for the provision of online training for our faculty, students and staff (citiprogram.org).
The Disaster Planning for the Research Enterprise(DPRE) is now available!!
• Training certificates are valid for three years.
• You must use the institutional email address when registering
• The institution for affiliation: Ponce Medical School Foundation
Training courses available are:
• Humans Subject Research
• Good Clinical Practice • Biosafety-Biosecurity
• Animal Care and Use
• Information Privacy and Security
• Responsible Conduct of Research
• Disaster Planning for the Research Enterprise (DPRE)
Ms. Minerva Ducot will be our Institutional Administrator for this initiative. Please contact her at email@example.com for any questions.
|Protocols already approved by IRB must be submitted at least one time per year for renewal purposes. At that time the following information must be addressed:
Also, we would like to remind all faculty and laboratory personnel dealing with protocols involving human subjects that they must take training courses available at
citiprotram.org, for all investigators and key personnel. Training certificates are valid for three years.
|Continuing Review Form|
|Welcome to STREAMLYNE, a New system experience|
PLEASE FOLLOW INSTRUCTIONS BEFORE ENTERING STREAMLYNE…
STREAMLYNE is an efficient online system for faster review and online approval. The primary objective of the implementation of Streamlyne at PHSU 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
|Login to Streamlyne
|**If you do not have a Streamlyne account, complete this form to request an account: http://j.mp/2Atz5pC **|