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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, Behavioral or Public Health)
✓ IPS (HIPAA) – Information Privacy Security
✓ Good Clinical Practice 
✓ Revised Common Rule

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.*

 

Welcome to STREAMLYNE

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
related to the protocol needs and save your responses frequently.  If you have any questions, please contact the Office of Research Development from Monday through Friday from 8:00 am to 5:00 pm at 787-840-2575 ext.4754.

Login to Streamlyne:

  1. Go to https://research.ponce.streamlyne.org
  2. PHSU employees can log in with your username and password.

Download: Streamlyne Quick Guide (Spanish and English), Creating an Amendment on Streamlyne.

To respond to the committee’s concerns or recommendations you must:

  • Submit a cover letter to the IRB Committee that includes each of the committee’s concerns (copy/paste). THIS DOCUMENT SHOULD BE IN PDF FORMAT AND PLACED IN THE NOTES & ATTACHMENTS SECTION.  PLEASE DO NOT SEND THIS DOCUMENT TO DR. SIMON CARLO.
  • Revisions in the answers to the Streamlyne Questionnaire MUST be followed by the letter “R” and the date (MM/DD/YYYY).  The IRB Committee requires this information as the platform does not allow highlighting revised text.
  • In the documents, use a highlighter (yellow)  to emphasize changes made.

**If you do not have a Streamlyne account, complete this form to request an account: http://j.mp/2Atz5pC **

For PHSU/PRI users, if you don’t remember your Streamlyne password or you need to reset it, please call (787)-840-2575 Ext. 5002 with the IT Department.

For external users,  if you do not remember your Streamlyne password or you need to reset it, please fill out this form: http://j.mp/2PMWcmy.  The process of password reset for the account will take from one to two labor days.  Once your password has reset, you will receive a notification to the email address provided with your login instructions.

STANDARD OPERATING PROCEDURES (Click to view full document)

Review Criteria (Click to view full document)

CITI PROGRAM CERTIFICATES

PHSU-PRI is affiliated with the “Collaborative Institutional Training Initiative – CITI Program – for the provision of online training for our faculty, students and staff (about.citiprogram.org).

  • You must use the institutional email address when registering
  • The institution for affiliation – Ponce Medical School Foundation

For Citiprogram Quick Guide, click here —————-

**Training certificates are valid for three years**

Mandatory Courses:

  • Question #4 – Human Subjects Research – Choose One
  • Investigators – Biomedical Research
  • Psychology (PsyD) – Social and Behavior Research
  • No direct contact with human subjects – Research with data or laboratory specimen
  • Question #8 – Information Privacy Security for Students and Instructors
  • Question #9 – Public Health Research – if you are in this School
  • Question #10 – Disaster Planning for the Research Enterprise (DPRE)
  • Question #13 – COVID -19

Other Courses:

  • Question #3 – Good Clinical Practice – Researchers in Clinical Trials and Clinical Research (If you work in hospital setting)
  • Question #5 – Responsible Conduct of Research
  • Question #6 – Biosafety
  • Question #12 – Revised Common Rule

IRB Streamlyne Renewals

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:

  • Number of subjects
  • Description – any adverse event or problems-How many subjects withdraw
  • Summary of any recent literature since last approval
  • A copy of the currently informed consent form
  • Fill out the “Continuing Review Form”

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 CITI PROGRAM, for all investigators and key personnel. Training certificates are valid for three years.

Member List

Simón E. Carlo, M.D., Chair
Biochemistry Department
Physician Representative

Idhaliz Flores Caldera, Ph.D.
Microbiology Department
Investigator and Faculty Representative

Vanessa Rivera Amill, Ph.D.
Basic Sciences Department – Microbiology
Investigator and Faculty Representative

Luisa Morales Torres, DrPH
Programa de Salud Publica
Investigator and Faculty Representative

Mary S. Rodríguez Rabassa, PsyD, MSc
School of Behavioral and Brain Sciences
Investigator and Faculty Representative

Eliut Rivera Segarra, Ph.D
School of Behavioral and Brain Sciences
Investigator and Faculty Representative

Eng. Elena Vélez López,
Community Representative

Mrs. Ivette M. Gracia Vega
Community Researcher and Representative

Mrs. Migdalia Cruz
Administrative Assistant
IRB Administrator
Alternate Member

Contacto

Simón E. Carlo, M.D.
IRB Chairman

Mrs. Migdalia Cruz 
IRB Administrator
Tel: 787-840-2575 Ext. 4758  Fax: 787-841-1040

Jean Torres Vázquez 
Streamlyne Administrator, IT Support
CITI Program Administrator
RedCap Administrator
Tel: 787-840-2575 Ext. 4754

Postal Address:
Ponce Medical School Foundation
PO Box 7004
Ponce, PR 00732

Physical Address:
388 Dr. Luis F. Sala Street
Ponce, PR 00716-2347

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