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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.

➢ 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. (ONE SINGLE 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.*

 

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. 4749 or 4754.

Login to Streamlyne:

  1. Go to https://research.ponce.streamlyne.org
  2. PHSU employees can login 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).
  • 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 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 the 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 log in 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
Basic Sciences Department – Biochemistry
Physician Representative

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

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

Luisa Morales Torres, DrPH
Public Health Program
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

Contact Us

Simón E. Carlo, M.D.
IRB Chairman

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

Ms. Minerva Ducot 
IRB Administrator
Tel: 787-840-2575 Ext. 4749

Jean Torres Vázquez 
Streamlyne Administrator, IT Support
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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