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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

✓ Flyers
✓ Posters
✓ Questionnaires
✓ Interviews
✓ 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 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.*

IRB Forms

Download All Forms(.zip file)

  • Continuing review form
  • Form 5 – Assent Form
  • Form 6 – Consent Form Template
  • Form 7 – Consent Form Case Report

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 mducot@psm.edu for any questions.

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 

citiprotram.org, for all investigators and key personnel. Training certificates are valid for three years.

Continuing Review Form
Member List
  • Simón E. Carlo, M.D., Chairman
    Biochemistry Department
    Physician Representative
    scarlo@psm.edu
    simoncarlo3@yahoo.com
  •  
  • Idhaliz Flores, Ph.D.
    Microbiology Department
    Investigator and Faculty Representative
    iflores@psm.edu
  • Vanessa Rivera Amil, Ph.D.
    Microbiology Department
    Investigator and Faculty Representative

    vrivera@psm.edu
  • Victoria Michelen, M.D.
    Basic Sciences Department
    Physician Representative
    vmichelen@psm.edu
  • Luisa Morales, PhD
    Public Health Program
    Faculty Representative
    lmorales@psm.edu
  • Mary Rodríguez, PsyD
    School of Behavioral and Brain Sciences
    Faculty Representative
    marodriguez@psm.edu
  • Axel Ramos, PhD
    School of Behavioral and Brain Sciences
    Faculty Representative
    axelramos@psm.edu
  • Eliut Rivera, PhD
    School of Behavioral and Brain Sciences
    Faculty Representative
    elrivera@psm.edu
  • Mrs. Mardie Geiser
    Local Business Owner
    Community Representative
    heladolady@gmail.com
  • Ms. Elena Vélez
    Community Representative
    evgutierrez@srcmd.com
  • Mrs. Migdalia Cruz
    Administrative Assistant
    IRB Administrator
    Alternate Member
    mcruz@psm.edu

For additional information, please contact:
Simon E. Carlo, M.D.
IRB ChairmanPostal Address:
Ponce Medical School Foundation
PO Box 7004
Ponce, PR 00732Physical Address:
388 Dr. Luis F. Sala Street
Ponce, PR 00716-2347
Tel: 787-840-2575 Ext. 4758
Fax: 787-841-1040Email: simoncarlo3@yahoo.com
mcruz@psm.edu

MEETING SCHEDULE

The meeting schedule of the Institutional Review Board for the current year is listed below. Please submit your protocol reasonably earlier than the date you project. 

MEETING DATE

DUE DATE FOR THE PROPOSAL

January 23, 2019

January 14, 2019

February 20, 2019

February 11, 2019

March 20, 2019

March 11, 2019

April 24, 2019

April 15, 2019

May 29, 2019

May 20, 2019

June 19, 2019

June 10, 2019

August 14, 2019

August 5, 2019

September 18, 2019

September 9, 2019

October 16, 2019

October 7, 2019

November 13, 2019

November 4, 2019

December 11, 2019

December 2, 2019

Simón E. Carlo, M.D.

IRB Chair

mcs

Contact Us

 

Postal Address:
Ponce Medical School Foundation
PO Box 7004
Ponce, PR 00732
Physical Address:
388 Dr. Luis F. Sala Street
Ponce, PR 00716-2347
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
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. 4251 or 4252.

Login to Streamlyne

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


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