Vice Presidency for Planning and Academic Affairs

Ana G. Méndez University System

Vice Presidency for Planning and Academic Affairs

Associate Vice Presidency for Sponsored Programs

Office of Regulatory Compliance

Human Research Protection Board (IRB)

RESEARCH PROTOCOL SUBMISSION FORM

(Applications without all requested information will not be accepted for IRB review)

For Office Use Only

Date Received
//
Mo Day Yr / Approval/Exemption Date
//
Mo Day Yr / Protocol #
--

Instructions: Before starting to fill out this form it is important that you revise all parts to make sure you have all the required documents for submission. This form should be completed in order to request IRB review for research involving human subjects. Incomplete or unreadable applications will not be accepted for IRB review. Download and complete this form and all other required documents. The 45 CFR 46 “Common Rule” prohibits that any research (including recruitment of subjects or advertising) be initialized without IRB review and approval. All researchers (i.e. Primary Investigators, Faculty, Mentor, Students and all key personnel) must receive educational training on Human Subjects Research in order to receive exemption or approval of their protocols from the IRB. All researchers and key personnel involved in investigations must complete the online training module on Human Subjects Protection at (http://phrp.nihtraining.com), HIPAA Privacy Rule and RCR Certificate (as required) at http://www.citiprogram.org) and include copy of certifications with this submission). Please refer to “Instructions for On-line Certification” which you can find in our webpage (compliance.suagm.edu). You should submit the obtained certifications and all other required documents to your Institutional Compliance Coordinator.

I. PRINCIPAL INVESTIGATOR INFORMATION

1. Name / Last Name / First Name / Graduate Degree
2. Mailing Address
3. Institution
University Center
School/Department/
Program
4. E-mail Address
5. Phone/Fax / Phone / Fax
6. Category / Graduate Student Undergraduate Staff Faculty Visiting Faculty Other
______

II. PERSONAL INFORMATION OF: Mentor Co-PI

1. Name / Last / First / Graduate Degree
2. Mailing Address
3. Institution
University Center
School/Department/
Program
4. E-mail Address
5. Phone/Fax / Phone / Fax
6. Category / Staff Faculty Visiting Faculty Other
Specify

NOTE: If the study has more than one CO-PI, please attach the information at the end of this document following this same format.

III. BASIC STUDY INFORMATION

1. Study/Protocol Title
2. Estimated Project Duration, after IRB approval / Starting Date: // Completion Date: //
MO DAY YR MO DAY YR
3. Research Purpose /
Undergraduate Master Thesis Doctoral Dissertation Other
Specify
4. Type of Funding /
Internal (Dean’s signature required) Non-Funded External
Specify
5. Performance Site
a) Inside AGMUS / Does not apply
If research will be done outside your main campus, please submit cooperation or support letter of the external performance site / Universidad Metropolitana, Main Campus
Aguadilla Metro Orlando
Jayuya South Florida
Bayamón
Universidad del Turabo, Main Campus
Yabucoa Ponce
Cayey Metro Orlando
Naguabo South Florida
Isabela
Universidad del Este, Main Campus
Cabo Rojo Yauco
Santa Isabel Metro Orlando
Barceloneta South Florida
Utuado
b)  External Performance Sites / (Please list any additional sites other than AGMUS where the research will be performed under the direction of AGMUS Principal Investigator (PI) or Co-PI. Eg. School Name, City or place.
Name of the External Site / Select as Appropriate and Submit Evidence
If there are more than four external places:
Provide attachment with information. / Cooperation or Support Letter
Cooperation or Support Letter
Cooperation or Support Letter
Cooperation or Support Letter
6. Additional Review
The IRB may require review by other AGMUS committees. Indicate if review and approval by these committees are applicable and the date of approval. Please provide documentation of review and approval. / Review Type / Review Required / Approval Date
Institutional Biosafety Committee (IBC)
Reviews the research of recombinant DNA
and its derivatives (biohazard agents) / Yes No / // MO DAY YR
Radiological Sub-Committee (IBC)
Reviews the use of radioactive drugs as well
as the purchase and use of radioisotopes in
humans (including research and routine). / Yes No / // MO DAY YR
Clinical Trials Review Committee / Yes No / // MO DAY YR
Institutional Animal Care and Use
Committee (IACUC)
Reviews the use and care of animals
as part of human subjects research. / Yes No / // MO DAY YR
Explosives/Carcinogenics/Drugs /
Yes No / // MO DAY YR
Hazardous Waste Generation /
Yes No / // MO DAY YR
Other Potentially Dangerous Substance /
Yes No / // MO DAY YR

IV. PURPOSE OF THE STUDY

A.  Summarize the purpose of the study using non-technical language (layman terms, approximately 400 words).

B.  What do you hope to obtain by doing this research? (Objectives of the study).

V. DESCRIPTION OF HUMAN SUBJECT POPULATION

As defined under the law 45 CFR 46, human subjects is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (i.e., pathological specimens, medical records and academic records, among others).

1. Number of Subjects
(Justify numbers) /
Both Genders (Total population to be use randomly) : approximately
If the study is directed to only one gender: Males : approximately
Females : approximately
2. Type of Subjects / AGMUS Students AGMUS employees
Healthy Volunteers Outpatients
Inpatients School Students
School Teachers Public Officials
Managers or business owners Other:
Specify
3. Subjects Age Range / 0 - 6 (submit consent of parent or legally authorized representative)
7 - 20 (submit consent of parent or legally authorized representative and child assent)
21 - 65
66 years or more
4. Special Study Populations
(check all that apply)
You must provide a rationale for using special populations in the Research Proposal / N/A Pregnant Women
Minors under age 21 Terminally ill
Diminished capacity to give consent Illiterate
Aborted fetuses or products of labor and delivery Non-Spanish speaking
Economically disadvantaged Prisoners or parolees
Physically or mentally challenged
Departmental Students as Subject Pools (Dept. )
Specify:
5. Summarize the inclusion and exclusion criterias. / Inclusion (Who are the study participants?):
Exclusion (Who are not the study participants?):

VI. RESEARCH PROCEDURES

Specify if your research proposal involves any of the following procedure(s). Be sure to include them in the proposal. For each item checked, please justify the necessity for it in your research proposal. Describe the precautions that will be taken to minimize risk (attach additional sheets if necessary).

YES NO
/ Please answer the appropriate yes/no check box and answer the questions if applicable.
1. * Does the study involve existing or archived data?, If YES indicate dates when the data will be collected:
2. Is the data collected anonymous? If NO, explain how the data was collected:
3. Does this study include Surveys/Questionnaires? If so, answer the following questions.
4. If the data collected is anonymous, does it cover sensitive or psychologically distressing topics?

* Provide a copy of the institutional permission/consent form authorizing access to this information by the study investigator. If it does not exist, please provide a certification statement from the person with access to data/tissue or of the person with access to the records or specimens involved in the study.

VII. SENSITIVE STUDY RELATED INFORMATION

YES NO
/ A. Does the proposal collect incriminating or sensitive information?
1. Is the information related to sexual attitudes, preferences, or practices/abortion?
/ 2. Is the information related to the use of alcohol, drugs or other addictive products?
3. Is the information pertaining to illegal conduct?
/ 4. Is the information related to learning disabilities?
5. If the information is released, could it reasonably damage an individual’s financial standing, employability, or reputation within the community?
/ 6. Is the information one that can normally be obtained from a patient’s medical record and could the disclosure reasonably lead to social stigmatization or discrimination?
/ 7. Is the information pertaining to an individual’s psychological well being, mental health, or genetics?
/ 8. Is the information related to depression or suicide?
Yes No
/ B. Does the research include third party information such as family history or sexual contact?
If YES, describe protection for consent and privacy of third party.
C.  Provide a detailed explanation, indicating how the subjects’ sensitive information in the study will be stored and protected.
D. Describe the specific procedures that will be used in order to ensure subject data confidentiality.
E. How long will the questionnaire and consent be stored? Please indicate, where the questionnaires will be kept and how these questionnaires and consents will be destroyed, after the study period has been completed.

VIII. RECRUITMENT PROCEDURES

A.  Will participants receive recruitment incentives or awards before and after the study
Yes No If YES, please explain
B. Indicate the types of recruitment materials to be used (check all that apply). Attach copies of all materials to this application.
Advertisements Television
Brochures Contact letters (physicians, teachers, etc.)
Newsletters Internet
Flyers/Posters Direct Contact
Letters Radio
Other (Specify)
C. Will subjects be recruited from a non-public registry? YES NO
If YES, specify the source:
NOTE: Include a letter from the Director of the Registration’s Office authorizing your access to the identifiable data for the purpose of this study. The letter needs to describe how access to the identifiable data is ethically possible (it confirms that subjects have given permission for contact and has authorized the distribution of their names and addresses).

IX. RISKS

Summarize the nature and risk (including side effects), substantial stress or discomfort that may occur by participating of this study. What are the potential risks/discomforts associated with each intervention or research procedure? If data is available, estimate: 1) the probability that a given harm will occur, 2) its severity, 3) its potential reversibility. What procedure(s) will be utilized to prevent/minimize any potential risks or discomfort? Examples or risks include physical risks, psychological risks (such as substantial stress, discomfort or invasion of privacy) and social risks (such as jeopardy to insurability or employability).
Select the overall risk classification of the research:
Minimal Greater than minimal

X. BENEFITS

1. The participant’s potential benefits include:
2.  The society’s potential benefit from the obtained knowledge include
3. Explain how the potential benefits of the research surpass the potential risks and how these risks are justified.

XI. RESEARCH SUBJECT INVOLVEMENT

Specify if your research proposal involves any of the following procedures. Be sure to include them in the proposal.

Please justify the necessity for each selected item in your research proposal. Describe the precautions that will be taken to minimize risk (attach additional sheets if necessary).

Check all that apply
Study of existing data¹; indicate the date when the data was originally collected: //
Specify mo/day/yr
Study of existing human biological specimens² Use of controlled substances
Study of prospectively collected human biological specimens³ Use of radioisotopes and/or radioactive agents
Audio and/or visual recording Surveys/questionnaires
Use of deceptive techniques Venipuncture
Interviews Genetic information
Observation of behavior Surgical Procedure(s)
Sensitive questions about personal issues Manipulation of psychological or social variables
Use of Microorganisms or recombinant DNA Questionnaire/Survey
Deprivation of physiological requirements (i.e. nutrition or sleep) Use of Medical devices
Use of Drugs and/or additive substances Materials/issues commonly regarded as socially
unacceptable
Other procedure(s) Specify:

1 Provide a copy of the institutional permission/consent form authorizing access to this information by the study investigator. If consent does not exist; please provide a certification statement for data/tissue access from the source of the records or specimens.
2 Specimens must be “on the shelf” at the time of submitting the application
3 Specimens will be collected after the study has started.
Note: If the study involves deception or intervention (behavioral or biological), when and how will the subjects be debriefed? Attach a copy of the debriefing script or letter.

XII. SCREENING PROCEDURES

HIPAA Privacy Regulations
The HIPPA Privacy regulations Screening Procedures are those performed to determine if an individual is eligible to participate in the study. When there is a pre screening, data may be obtained that can identify possible or eligible participants of your study. Only minimal eligibility requirement questions (inclusion-exclusion) should be addressed. Please check one of the following options utilized to handle the pre-screened data obtained for your study.
Screening data will NOT be shared with individuals outside of the Ana G. Méndez University System
Screening data WILL be shared with individuals outside of the Ana G. Méndez University System. Submit a “Waiver of Authorization”.
This protocol does not involve pre-screening. All subjects are either recruited through advertisements or
through direct contact with them. There is no prior review of the participant’s medical record other than
standard care.

XIII. RELATIONSHIP BETWEEN THE INVESTIGATOR AND PARTICIPANTS OF A STUDY

Indicate if there is any type of relation between the investigator and the participant of the study. (e.g., professor/student, supervisor/employee, health professional/patients or clients, among others).
No, there is no relation between the investigator and participant
Yes, a relationship exists between investigator and participant
If your answer is “Yes”, explain and describe what precautions will be taken to avoid conflict of interest and assure voluntariness that will guarantee: lack of coercion, freedom of choice, and undue influence.
Note: This information should also be included in the consent document.

XIII. CONFIDENTIALITY

1. Are subjects asked to fill out any materials that are shared with other groups (e.g., voluntary health organizations, advocacy groups) that provide identifiers? No Yes
If YES, specify:
2. Will the subjects’ data be coded? No Yes If YES, specify:
3. Will the generated data be used for purposes other than this research project? No Yes If YES, describe:
4. Will subject information or coded data be available for any of the following?
Check all that apply. NOTE: Data obtained should always be available for IRB review.
Principal Investigator NIH FDA
Study sponsor Mentor Other, specify:
5. Will any data be gathered through photographic, video or sound recording devices? No Yes
If Yes, specify:
If what is specified un the consent document, describes what security levels will be used to protect the confidentiality of the materials (e.g., Who will have access to them?, How will they be stored?, and How long will they be stored? , among others).
6. What are the plans for the final disposition or destruction of any identifiable data? Include electronic media, such as audio, photo, videotape or web-site data.

XIV. FINANCIAL INFORMATION