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
✓ 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:
- Go to https://research.ponce.streamlyne.org
- PHSU employees can log in with their 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.
“Why is my protocol not being reviewed yet?/What is the status of my protocol?”
- This means that your protocol is missing an Approval. You can check the status by entering the protocol in EDIT – Protocol Actions – Route Log. There you will see the list of people that are missing to approve. If you’re have to APPROVE the protocol then enter the protocol by EDIT – Protocol Actions – Press the orange button below that says “APPROVE“.
“How do I have access to Streamlyne?”
- Please complete this form to request an account: http://j.mp/2Atz5pC , from 1 to 3 days an email should be sent with the credentials needed to enter Streamlyne.
“How do I enter CITI Program?”
- Follow the link: about.citiprogram.org, you can download the instructions in the CITI Program Section as well as the mandatory ceritifcates to take
“I can’t enter Streamlyne, my password expired“
- If you have an e-mail from PHSU (@psm.edu or @stu.psm.edu) and not recall the password, please contact 787-840-2575 Ext. 4814 or email itsupport@psm.edu.
- If you are an external user and do not remember your password or wish to be re-established, please fill the following form: http://j.mp/2PMWcmy.
“If one of my sites is PHSU Wellness Center, who should I contact to provide me with an authorization letter?”
- To have and authorization letter from the PHSU Wellness Center, you may contact Dr. Juliette Rivera Collazo (Clinical Manager of PHSU Wellness Center.
“How to I start an Amendment in Streamlyne?”
- Click here to download full instructions. (this instructions apply for approved Expedited and FullBoards)
*Remember that Exempt protocol can’t be amended. For Exempts you must enter your protocol by Edit – Protocol Actions – Copy to New Document (select the option to copy the questionnaire)
“My information isn’t saving when I switch pages/ I can’t figure out how to add information to my record.”
- Be aware of buttons and features used to collect/incorporate data in Streamlyne, such as the looking glass tool and particularly the “Add” button where available. These are often overlooked and can sometimes even be hidden off the side of the screen depending on your screen’s zoom. For example, this error commonly occurs in the “Participant Types” section when adding the type and number of participants.
“I can’t submit my protocol.”
- Check for errors in the “Validation” section in the “Protocol Action” tab. Clicking “show” and “fix” will help you identify the errors and take you to the page where you can fix them.
- Be sure all the fields in the “Protocol” tab marked with an asterisk are filled out.
- In the “Questionnaire”, be sure to provide an answer to every question of the “New IRB Protocol” section.
“What if I have a key person who isn’t available in the “Personnel” lookup?”
- If someone does not have a Streamlyne account, complete this form to request an account: http://j.mp/2Atz5pC
“Do I need to fill out the Explanation and Document Number boxes on the first page?”
- No
“Where should I attach CITI training certificates?”
- Please use the “Personnel” tab to add completed CITI certificates for Human Subjects Research and Information Privacy Security (IPS) for all researchers on a protocol.
“How to protect human subjects data?”
- For more information on this please visit: https://ori.hhs.gov/content/Chapter-6-Data-Management-Practices-Data-protection
Universidad Interamericana de Puerto Rico, Recinto de San Germán
Clínica de Consultoría y Servicios Psicológicos
Physical Address: Universidad Interamericana de PR, Clínica de Consultoría y Servicios
Psicológicos, Recinto de San Germán, Edificio Harris Hall, Oficina 101
Tel: (787) 264-1912, Exts. 7713 ó 7718
Universidad Interamericana de Puerto Rico, Recinto Metropolitano
Servicios Psicológicos – Clínica Interamericana
Tel: (787) 250-1912 Ext. 2586, 2587
Universidad Carlos Albizu, Recinto de San Juan
Clínica de Salud Mental de la Comunidad
Address: 151 Calle Tanca San Juan, PR 00901
Tel: (787) 725-6500, ext 1582
Universidad Carlos Albizu, Recinto de Mayagüez
Clínica de Salud Mental de la Comunidad
Physical Address: 56 Calle José De Diego,Mayagüez, P.R. 00680
Tel: (787) 838-7272, ext. 7137
Pontificia Universidad Católica, Recinto de Ponce
Clínica Interdisciplinaria de Servicios a la Comunidad
(787) 841-2000, ext. 2414
Physical Address: A. Ferré Suite 631 Ponce, PR 00717-9997
Tel: (787) 841-2000 Ext. 2413/2414
Ponce Health Sciences University
A. PHSU Wellness Center:
Dirección: 396 Luis F. Sala Zona Industrial 2, Ponce, Puerto Rico
Tel: (787) 812-2525
B. Clínica de Servicios Psicológicos (CSP):
Dirección: 396 Luis F. Sala Zona Industrial 2, Ponce, Puerto Rico
Tel: (787) 812-2525
Universidad de Puerto Rico, Recinto de Río Piedras
CUSEP: Centro Universitario de Servicios y Estudios Psicológicos
Tel: (787) 764-0000, ext 3545,7436, 87680, 87681
Dirección física: Avenida Universidad, #55, Edif. Rivera, Río Piedras, PR. 00925
Centro Ponceño de Autismo (CEPA)
Dirección física: 106 Calle Sol #118, Ponce, 00730
Tel: (787) 284-2900
Centro StarBright Academy
Dirección física: 28-38 PR-14, Ponce, 00733
Tel: (787) 840-7747
Linea PAS de ASSMCA
(Línea de prevención de suicidios y para cuidadanos que lidean con addición a drogas)
Tel: 988 or 1-800-981-0023
988 Suicide and Crisis Lifeline
The 988 Suicide and Crisis Lifeline provides 24/7, confidential support to people in suicidal crisis or mental health-related distress.
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 the one)
– Biomedical Basic Refresher/Research (School of Medicine)
– Psychology (PsyD) – Social and Behavior Research – Applies only if you are from the School of Behavioral and Brain Sciences
- Question #8 – Information Privacy Security for Students and Instructors
- Question #9 – Public Health Research – Applies only if you are from the Public Health Program
Other Courses (MANDATORY FOR Specific Settings):
- Question #3 – Good Clinical Practice – Researchers in Clinical Trials and Clinical Research (If you work in hospital setting)
- Question #6 – Biosafety (if the study involves saliva or blood samples)
Templates
Download All Forms (.zip file)
- Streamlyne Study Questionnaire
- IRB Committee Concerns (To answer Specific Minor Revisions and Substantive Revisions)
- Continuing review form
- Form 5 – Assent Form
- Form 6 – Consent Form Template (Spanish)
- Form 6 – Consent Form Template (English)
- Form 7 – Consent Form For Case Report (Spanish)
- Form 7 – Consent Form For Case Report (English)
- IRB Bio specimen Consent Form
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.
Committee Member List
2022-2023
Simón E. Carlo, M.D., Chair
Basic Sciences -Biochemistry Division
Physician Representative – Pediatrics/Genetics – Scientific
Idhaliz Flores Caldera, Ph.D.
Basic Sciences – Microbiology Division
Women’s Health Division
Investigator and Faculty Representative – Scientific
Vanessa Rivera Amill, Ph.D.
Basic Sciences Department – Microbiology
Investigator and Faculty Representative
Luisa Morales Torres, DrPH
Public Health Program – Epidemiology
Investigator and Faculty Representative – Scientific
Mary S. Rodríguez Rabassa, PsyD, MSc
School of Behavioral and Brain Sciences
Investigator and Faculty Representative – Scientific
Caleb Esteban Reyes, Ph.D.
School of Behavioral and Brain Sciences
Investigator and Faculty Representative – Scientific
Eliut Rivera Segarra, Ph.D.
School of Behavioral and Brain Sciences
Investigator and Faculty Representative – Scientific
Doris A. Andújar-Pérez, MPH
Public Health – Scientific
Director of Special Projects, PRI
Executive Program Manager, RCMI Program
Carmen Judith Acosta Fumero, EdD
Community Representative – Non-Scientific
Jose Vega Albertorio, BS
Community Representative
Mrs. Migdalia Cruz, ASS
Administrative Assistant
IRB Administrator
Alternate Member
Jean M. Torres Vázquez, SWE
Administrative – Cyber Security – Non-Scientific
Streamlyne/CITI Program/RedCap Administrator
Contact Us
Simón E. Carlo, M.D.
IRB Chairman
Mrs. Migdalia Cruz
IRB Administrator
Tel: 787-840-2575 Ext. 4758 Fax: 787-841-1040
Amarilys Santiago Rivera
IRB Administrator
Tel: 787-840-2575 Ext. 4720
Jean Torres Vázquez
IT Support
Streamlyne Administrator
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
