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)
STUDY/RESEARCH SUBMISSION FORM
Please download this form and after completing you must upload in the IRBNet System.
For instructions on how to complete required documents visit our website http://compliance.suagm.edu
(Applications without all requested information will not be accepted for IRB review)
Instructions Before starting to fill out this form it is important that you review 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 this form, complete and upload again in the IRBNet System with all other documents required. 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 (IRB) Privacy and Confidentiality and RCR Certificate (as required) at (http://www.citiprogram.org) 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 also upload the obtained certifications in IRBNet System with other required documents.
I. PRINCIPAL INVESTIGATOR INFORMATION
1. Name / Last Name / First Name / Graduate Degree2. 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 Degree2. 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/ResearchTitle2. 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 supervision 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/RESEARCH
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) : maximum of
If the study is directed to only one gender: Males : maximum of
Females : maximum of
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, child assent will be required from 7-13 years of age)
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. Will the data be collected anonymous? (the participant cannot be identified) Explain how the data will be collected:
3. Will the data be collected partially anonymous? (the participant can only be identified by the investigator) Explain how the data will be collected:
4. Does this study include Surveys/Questionnaires? Explain:
5. 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 OR INCRIMINATING STUDY RELATED INFORMATION: This part should be answered, even if the Researcher understands that the study/research submitted does not include sensitive or incriminating information.
YES NO/ A. Does the proposal collect incriminating or sensitive information?
1. Will the collected information be related with sexual attitudes, preferences, or practices/abortion?
/ 2. Will the collected information be related with the use of alcohol, drugs or other addictive products?
3. Will the collected information be pertaining with illegal conduct?
/ 4. Will the collected information be related with learning disabilities?
5. If the information is released, could it reasonably damage an individual’s financial standing, employability, or reputation within the community?
/ 6. Will the collected information be considered as one that can normally be obtained from a patient’s medical record and could the disclosure reasonably lead to social stigmatization or discrimination?
/ 7. Will the collected information be pertaining to an individual’s psychological well-being, mental health?
/ 8. Will the collected information be related with depression or suicide?
9. Will the collected information be related with genetics or heritage?
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 documents be stored (questionnaires, consents and others)? Please indicate where the questionnaires will be kept and how will they be destroyed, after the study period has been completed.
VIII. RECRUITMENT PROCEDURES
A. Will participants receive recruitment incentives or awards before and after the studyYes 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 Risk (fatigue, discomfort that is normally encountered in daily lives activities)
Greater than minimal risk (substantial stress, social risk or risks related to invasion of privacy and breach of confidentiality )
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 applyStudy 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)
Manipulation of psychological or social
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 RegulationsThe 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 study/research 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/RESEARCH
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 voluntariness that will guarantee: lack of coercion, freedom of choice, and undue influence.
Note: This information should also be included in the consent document.
XIV. CONFIDENTIALITY