UVI IRB Protocol Review Form

UVI IRB Protocol Application for the Involvement of Human Participants in Research

This form must accompany the IRB Face Page

Office of Sponsored Programs

#2 John Brewer’s Bay St Thomas, VI 00803 (340) 693-1176

SECTION I: General Information

Study Title:

SECTION II: Collaborating Institutions/Facilities and Other IRB Reviews

YES NO Does any part of the conduct of this research, including recruitment, enrollment/consent, study procedures, follow-up, data gathering, or data analysis take place in a location other than UVI?

YES NO Will another organization or entity be involved in any way in the conduct of this research?

(If no to both, skip to Section III)

Collaborating Institutions/Facilities

YES NO Does the PI or other Key Personnel have an affiliation/appointment with an institution listed above? If yes, explain the nature of the affiliation:

YES NO Does your collaborating institution(s) have an IRB?

YES NO PENDING Have any non-UVI IRBs reviewed this research protocol?

You will need to obtain IRB approval from every collaborating institution that has an IRB before you can initiate research there. Provide a copy of all pending and/or approved research protocols from all collaborating institutions.

Note: VI K-12 approval must be obtained from the Office of Testing, Planning, Research, and Evaluation at the VIDOE. VI K-12 research applications are available at OSP or on the OSP web page.

International Research

YES NO Will any aspect of the study take place outside of the United States? (If no, skip to Section III)

YES NO Is the PI or other Key Personnel affiliated with a non-US Institution listed above?

If yes, explain the nature of the affiliation:

NOTE: You will need to obtain IRB approval in the country where the research is taking place and/or a Federal-wide Assurance filed with the Office of Human Research Protections (OHRP). Please contact OSP for additional information.

SECTION III: Funding

YES NO Is this research/study externally funded, or have you submitted a grant application in order to fund this research/study?

(If no, skip to Section III)

Externally Funded Studies:

For each funding source, please identify the following (as applicable):

YES NO IS THIS PROTOCOL SUBJECT TO NIH JUST-IN-TIME PROCEDURES?

YES NO Will funds from this contract/grant be awarded or contracted to any external individual or institution engaging in human subjects research?

NOTE: If the research is supported either in whole or in part by external funds (federal, state or private), one COMPLETE copy of each grant application and award document must be submitted with this application. It is the responsibility of the Principal Investigator to notify the IRB if the funding source changes.

SECTION IV: Conflict of Interest (only required for externally funded research)

YES NO Does any investigator listed on this protocol or their immediate family member(s) have a financial interest in the outcome of this research or study?

If yes, you must submit an updated UVI Conflict of Interest Disclosure Form to the appropriate Institutional Authority indicated on the form and in the UVI Conflict of Interest Policy. (Both available on the OSP web page).

SECTION V: Human Participants

1.  How many participants will be enrolled in the study?

NOTE: If you are enrolling more than one population describe the total enrollment for each. Note: Participants are generally considered to be ‘enrolled’ when they sign the consent form or have gone through an oral consent process. Therefore, be sure to account for attrition in your enrollment number.

2.  Describe the participant population(s) including gender, ethnicity, age range, income, level of education, and language spoken.

3.  Describe the recruitment process including who will recruit, when and where recruitment will take place and how participants will be identified and recruited (e.g., direct recruitment by study team in person, on the phone, by mail/email/internet, random sampling, referrals from other participants or agencies).

NOTE: You must attach copies of all advertisements/recruitment materials for IRB review including phone scripts, web postings, and newspaper advertisements.

Special Participant Population(s):

Identify any special population(s) that you will be specifically targeting for the study. (Check all that apply).

UVI Students or Employees:

YES NO Are you recruiting students who are in a class you teach or for which you have responsibility?

YES NO Are you recruiting employees who report to you?

If special populations are involved in this research, explain why this population is necessary to the study and indicate precautions taken by the researchers to minimize potential undue influence or coercion:

SECTION VI: Drugs/Devices, Genetic Testing, and Biological Samples

Does your research involve any of the following? Check all that apply.

YES NO The use of any drug or medical device.

If “yes” please describe.

YES NO The use of biological samples.

If “yes” please indicate the manner in which the samples will be obtained, stored, and disposed of.

YES NO Genetic testing of biological samples.

If “yes” please indicate what information will be obtained, how confidentiality will be maintained, what will happen to the samples and data after completion of the study.

SECTION VII: Research Plan

1.  State the reason for the study, the research hypothesis, and the goals of the proposed study as related to the research hypothesis.

2.  Provide a summary of the background information that led to the plan for this project. Provide references as appropriate and, when applicable, previous work in animal and/or human studies. If previous UVI human subjects research is involved, identify the prior research study.

3.  Indicate the expected start and completion dates for this study.

4.  What, if any screening procedures will be used to identify research subjects. List major inclusion and exclusion criteria. Any proposed exclusion criterion based on gender (women of childbearing potential), age, or race must include a justification for the exclusion.

5.  Describe the conditions under which participants may be removed from the study, i.e., noncompliance with study rules, study termination, etc. NOTE: The IRB strongly suggests that investigators incorporate flexibility into the study design to accommodate anticipated events (i.e. explain how missed study appointments can be made up by participants).

6.  If the research involves study of existing samples/records, describe how authorization to access samples/records will be obtained.

7.  If applicable, describe the use of audiotape and/or videotape and provide justification for use.

8.  If the study includes measures, survey instruments, or questionnaires, identify each and, if available, provide references for the measures. Describe what they intend to measure, how this relates to purpose/hypothesis, and their psychometric properties (e.g., reliability and validity). Identify any measures, survey instruments, or questionnaires that were specifically created for the study.

9.  Describe any and all potential risks to participants and steps taken to minimize risks. Assess the likelihood of the risk occurring and, if it were to occur, the seriousness to the participant. Types of risks to consider include: physical, psychological, social, legal, employment, and financial. Also describe any anticipated inconveniences the participants may experience (time, abstention from food, etc.)

10.  Describe any anticipated benefits to the individual participants. If individual participants may not benefit directly, state so here. Describe anticipated benefits to society (i.e., added knowledge to the field of study) or a specific class of individuals (i.e., athletes or autistic children). NOTE: Do not include compensation in this section.

11.  Risks to research participants should be justified by the anticipated benefits to the participants or society. Provide your assessment of anticipated risks to participants and steps taken to minimize these risks, balanced against anticipated benefits to the individual or to society.

12.  Describe any costs to the participants or amount and method of compensation that will be given to them. Describe how you arrived at the amount and the plan for compensation; if it will be prorated, please provide the breakdown. Experimental or extra course credit should be considered an economic consideration and included in this section. Indicate when compensation will be given to participants, or if applicable, when the random drawing will take place.

13.  Describe how the privacy interests of participants will be maintained during the study (note that privacy pertains to the individual not to the data).

14.  Describe procedures for protecting confidentiality of data collected during the study and stored after study closure. Describe how data, including electronic data, will be coded, stored, secured, and how and when it will be disposed of or destroyed.

15.  If identifiable, sensitive information (illegal drug use, criminal activity, etc.) will be collected, state whether a Certificate of Confidentiality will be obtained. Be sure to state whether any limits to confidentiality exist and identify any external agencies (study sponsor, FDA, etc.) that will have access to the data. Contact Sponsored Programs for more information.

16.  If participants will be screened, describe the plans for storage or destruction of identifiable data for those that failed the screening.

If this study offers treatment for participants’ conditions, answer the following. If not, skip to section VIII.

1.  What is the current standard of care?

2.  How do the experimental procedures differ?

3.  Will all participants receive current therapy in addition to the study procedures, or will the current therapy be stopped?

4.  If the current therapy will be stopped, provide a justification for doing so.

5.  Justify, if applicable, the inclusion of a placebo group, blinding or not blinding the study.

6.  Describe the conditions under which participants will be removed from the study or have the experimental procedures stopped.

7.  Describe what happens with therapy when the study ends (i.e., participant resumes original treatment plan).

SECTION VIII: Informed Consent

As PI, you are responsible for taking reasonable steps to assure that the participants in this study are fully informed about and understand the study. Even if you are not targeting participants from “Special Populations”, such populations may be included in recruitment efforts. Please keep this in mind as you design the Consent Process and provide the information requested in this section.

1.  Describe the consent process including who will obtain consent, where and when will consent be obtained, and how much time participants will have to make a decision.

2.  Describe how the privacy of the participants will be maintained throughout the consent process.

3.  State whether an assessment of consent materials will be conducted to assure that participants understand the information (may be warranted in studies with complicated study procedures, those that require extensive time commitments, those that expose participants to greater than minimal risk, and with some populations, including limited English proficiency, those with limited decision-making capacity).

4.  Describe how the capacity to consent will be assessed for participants with limited decision-making capacity, language barriers or hearing difficulty. If a participant is incapable of providing consent, you will need to obtain consent from the participant’s legal guardian.

5.  If enrolling children, state how many parents/guardians will provide permission, whether the child’s assent will be obtained and if assent will be written or oral. Provide a copy of the script to be used if oral assent will be obtained.

NOTE: Copies of all forms should be attached to this application in the same format that they will be given to participants. It must be made clear which participant population, i.e., adult, child, surrogate the form is intended for. Copies of oral scripts and audio, video, or electronic consent forms must also be provided.

Waiver or Alteration of Consent

Under certain circumstances the IRB may approve a waiver of consent (participants will not be asked to give consent to participation), a waiver of signed consent (participants will give consent verbally after reading an information sheet), or an alteration of consent (the participants will be intentionally deceived as to the nature of the study or their participation in it).

If you do not intend to request any of the waivers listed above, skip to section IX.

NOTE: Under no circumstances should a waiver of consent be construed as approval to coerce participation or as a means to erode participants’ rights.

YES NO Does the research include any activities that would require signed consent in a non-research setting? For example, in non-research settings, normally there is no requirement for written consent for completion of questionnaires. Explain your answer.

YES NO Does this research constitute more than minimal risk to the participants? Justify your answer.

YES NO Does a breach of confidentiality constitute the principal risk to participants?

YES NO If you answered “yes” to the previous questions, will this risk be minimized because of the waiver of signed consent?

YES NO Would the research be impracticable without the waiver? If “yes” explain how:

YES NO Is there important information that will need to be related to participants during or after the completion of the study? If “yes” how will this information be communicated to them?

Studies Using Deception

Explain how the research could not be done if participants knew the full purpose of the study or their role in it.

How will participants be debriefed at the conclusion of the study?

YES NO Will researchers be available after the conclusion of the study to answer participant questions?

Section IX: Principal Investigator Certification