Sistema Universitario Ana G. Mendez

Sistema Universitario Ana G. Mendez

SISTEMA UNIVERSITARIO ANA G. MENDEZ

Vice Presidency for Planning andAcademic Affairs

Associate Vice Presidency for Sponsored Programs and Compliance

Office of Regulatory Compliance

Human research protecTion board (IRB)

RESEARCH CLOSURE FORM

Download this form completeand upload with all other documentsthrough the IRBNet System

Applications must include all requested information in order to be accepted for IRB review. For more instructions on how to submit an additional package refer to ()PI's may contact Compliance Coordinators for additional information or other documents that may be required by your institution.

Proposal Title:
Name of Principal Investigator / Last Name Name/Inicial / Current Academic Degree:
Email: / Mobile Phone:
Mailing Address:CityStateZipCode
Institution/Campus: / Telephone:
Student: Yes  No / School/Department:
Name of Mentor/Co-Investigator: / Telephone:
Funded/Sponsored by: / Amendment Number:
Contact Person: Mobile Phone:
Initial Approval Date: / Expiration Date: / /
(mo-day-yr)(mo-day-yr)
Date of most recent continuing (renewal) Approval:/ / /
(mo-day-yr)
Notice: If Research was submitted to the approval of other Regulatory Committees (ACUC or IBC) It is responsibility of the PI to inform of the Closure.

Section A – Research Status–Select one of the following alternatives:

1. Research Completed
2. Research Cancelled (was never initiated)
3. Research Completed previous to expiration date
4. Research Transferred (Population/Subjects not available or transferred to another institution)

If one of the alternatives from two (2) to (4) was selected, describe the reasons:

Section B - Recruitment

Gender and Number of Participants: / Female / Male / Total
Recruited since the initial study process
Recruited since the last renewal, if it applies
Total of recruited participants

Section C–Incidents or Adverse/Non Anticipated Events

1. Indicate if incidents or adverse events were reported? If your answer is Yes, Explain; if your answer is No refer to Section D.
Explain: / Yes / No
2. Was the Regulatory Compliance Office informed of the incident or adverse event? / Yes / No

Note: All adverse or non-anticipated events must be reported to the IRB completing Form IRB_F05. Contact your Institutional Compliance Coordinator.

A- Explainthe Adverse/Non Anticipated Event.

Section D – Confidentiality and Data Security (Select all that may apply)

1. All obtained documents/materials and data were destroyed.
2. All personal identifiable information that may connect participants with archived documents was destroyed.
3. Allcollected data will be stored in a safe place for five (5) years.
4. The participants cannot be related or connected with the Research.
5. If option number three (3) was selected, explain the planned process on how the obtained information will be kept (how, when and where) and how and when will it be destroyed.
Explain:

Section E- Was the Research published or have presentations been made?

If answer is Yes, Explain
If it is a thesis indicate the date of dissertation:/ / (Mo/day/Yr)

Section F. STUDENT’S/ PRINCIPLE INVESTIGATOR ASSURANCE: PI will sign electronically through the IRBNet Platform provided by SUAGM, when indicated in the process. By doing so, you agree to the following:

  • I certify that the information provided in this application is complete and correct.
  • I understand that as Principal Investigator, I have ultimate responsibility for the protection of the rights and welfare of human subjects, conduct of the study and the ethical performance of the project.
  • I agree to comply with all of Sistema Universitario Ana G. Méndez (SUAGM) policies and procedures, as well as with applicable federal, state and local laws regarding the protection of human subjects in research.

Section F. INSTITUTIONAL ENDORSEMENT: To receive appropriate endorsement share completed form and all other related documents with the following staff of your Institution who should sign electronically using the IRBNet Platform provided by SUAGM.
FACULTY RESEARCH SUPERVISOR/MENTOR- REQUIRED FOR STUDENT RESEARCH
I certify that as faculty research supervisor I attestthat I have read the attached protocol submitted for IRB review, and agree responsibility on educating on ethical performance and supervising the student in the process of recruiting participants, obtaining consent and of data collection.
DEAN This is to certify that I have reviewed this research protocol and that I attest to the scientific merit of this study and the competency of the investigator(s) to conduct the project.

For assistance please contact the Compliance Coordinator at your institution

through the IRBNet System (see instructions

UMET (787) 766-1717 ext. 6362; E-mail:

UNE (787) 257-7373 ext. 2279;E-mail:

UT 787-743-7979 ext. 4126; E-mail: ; FAX (787)743-7115

EEUU SUAGM University System (813) 932-7500 ext. 8711; E-mail:

Office of Regulatory Compliance (787) 751-0178 ext. 9-7195; Email

To report an Adverse Event: E-mail ; (787) 751-0178 ext 7195 and 7197

Or to report Non-Compliance in Research: Email ; Tel. (787) 751-3120

SUAGM_IRB_Closure Form_04
Eng_Ver (Rev 07/2016) Page 1 of 4

APPENDIX 1: TABLE OF MINOR AND MAJOR CHANGES

Minor Changes / Major Changes
Administrative Changes
  • Editorial changes that clarify but do not alter the existing meaning of a document.
  • Minor changes to recruitment procedures such as: recruitment materials or submission of new recruitment materials to be used in accordance with approved recruitment methods.
  • Addition of or changes in study personnel, except for PI or Co-PI changes.
  • Translations of materials/documents already reviewed and approved by an IRB.
Expedite Review Changes
  • Minor consent form changes.
  • Minor changes to study documents such as: surveys, questionnaires or brochures.
  • New study documents to be distributed to or seen by subjects that are similar in substance to those previously approved.
  • Changes in payment to subjects or the amount subjects are paid or compensated that are not significant enough to affect the risk/benefit ratio of the study.
  • Decrease in the number and volume of sample collections as long as they do not negatively alter the risk/benefit ratio of the study.
  • Addition of a new study site (in many but not all cases).
/ Convened Meeting Review
  • Changes that adversely affect the risk/benefit ratio of the study or specifically increase the risk to subjects.
  • Changes in inclusion/exclusion criteria that impact the risk/benefit ratio of the study.
  • Significant changes in study design, such as the addition of a new subject population or the elimination of a study arm.
  • New risk information that is substantial or adversely affects the risk/benefit ratio of the study.
  • Significant changes to the study documents to be distributed to or seen by subjects.
  • New study documents to be distributed to or seen by subjects that include information or questions that are substantively different from materials already approved by the IRB.
  • New or revised financial conflict of interest management plans (e.g., change in PI or change to study design).
Specific changes in clinical studies
  • Addition of new study drug or device to the protocol design.
  • Change to the study drug dose.
  • Change to the protocol eligibility criteria
  • Amended Investigators brochure involving a change in risk.
  • Revised consent form risk language.
  • Addition of a Chest X-Ray to a previously considered minimal risk study.
  • Change to protocol response criteria.

Important Notice: These are examples of minor and major changes to guide in the revision process of changes in protocols previously approved, but it is not limited to, other changes can be considered.

SUAGM_Appendix 1_Changes

7/2016Page 1 of 4

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