VIRB Application

VIRB Application
PART 1: RESEARCHER INFORMATION
Lead Investigator:*
Position/Title:*
Email:*
Phone:*
Additional Investigators (include emails):
Organization Type:*

AcademicNonprofitGovernmentPrivateOther (Please Describe)
Have you completed the HHS Human Research Protection Training or another similar human subjects training (e.g., PPRE, CITI Program)?*

YesNo
Please upload your human subjects training certificate(s) here.

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PART 2: PROJECT INFORMATION
2.1 Does your project meet the federal definition of research? (The federal definition of research is a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge)*

YesNo
2.2 Does your project meet the definition of human subjects research? (The definition of human subjects covers any living individual about whom an investigator, whether professional or student conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.)*

YesNo
2.3 Project Title:*
2.4 Project Type (select all that apply):*

Not defined as research: A project conducted using existing public information, such as a literature reviewNot human subjects: A project conducted without obtaining information through interactions with human subjects or their identifiable, private informationArchival research: A project conducted with research gathered entirely from archival records, such as US Census dataClassroom research: A project conducted with information intended to stay within the confines of a course/classroom or within a specified organizationQuality improvement projects: A project conducted to bring about immediate improvements in delivery of system/organization performanceClinical trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomesTaste/food quality evaluation or consumer acceptance project: A project involving consumptions of wholesome foods with or without additives, ingredients, or other chemicals deemed safe by the Food and Drug Administration and/or the U.S. Department of Agriculture.Thesis, dissertation, or Plan B project: A project conducted for degree completion.Survey, interview, or observation project: A project that will primarily use survey, interview, observation, or diagnostic testing procedures.Public dissemination: A project conducted with intent to be published and/or presented outside the classroom or organization.Journalistic activities: A project conducted with the intent to publish a newspaper article
2.5 Anticipated Project Dissemination:*

Public dissemination: The researchers intend to publish and/or present this study outside the classroom.Not for public dissemination: The researchers do not intend to publish and/or present this study outside of the classroom.
2.6 Desired Start Date:*

MonthDayYear
Date
2.7 Sponsor(s):*

FederalNon-FederalFunding PendingUnfundedUnsure
2.8 Description of Research (250-500 word summary)*

0/500
2.9 Methodology/Procedures of Research (describe the role/activities of participants of the study)*
Please upload any measures or protocols here

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2.10 Please describe what benefits your research may have for society.*
PART 3: PARTICIPANT / SUBJECT INFORMATION
3.1 What is the expected number of participants or sample size?*
3.2 What or who is your intended participant pool?*
3.3 What is your relationship with participants?*
3.4 Please identify any vulnerable populations you intend to include in your participant pool (select all that apply).*

Pregnant Women, Human Fetuses, NeonatesPrisonersEconomically and/or Educationally DisadvantagedMinors (Under the Age of State Majority - typically < 18)Individuals with Impaired Decision-Making CapacityLegally Incompetent PersonsNone of the above
3.5 Are you recruiting participants who are not fluent in English?*

YesNo
3.5.1 If yes, attach translation documents to your application package – including details about who will be translating the materials.*

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3.6 Will you be recruiting participants and including recruitment materials with protocol?*

YesNo
3.6.1 If Yes, how will you be recruiting participants (i.e., include text to be used to recruit participants)*
3.7 Will your participants be paid or compensated in any way?*

YesNo
3.7.1 If yes, how will participants be paid or compensated for their participation?*
3.8 Does the study involve (a) deception (providing false information) or (b) incomplete disclosure (withholding information about some or all of the research purpose or procedures) in order to maintain the scientific integrity of the study?*

YesNo
3.8.1 If Yes, explain the rationale and plans for protecting participants (e.g., debriefing).*
PART 4: CONSENT
4.1 How will participants consent to their participation in research? (check all that apply)*

Acknowledgement by written signatureAcknowledgement by click box (e.g., on a survey)Acknowledgement by implied consentAcknowledgement by digital or other legally acceptable electronic signature: Waiver of signature (when allowable under regulations)Acknowledgement by digital or other legally acceptable electronic signature: Waiver of consent (when allowable under regulations)
4.2 Summarize the process for obtaining consent.*
Please upload any consent documentation here

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PART 5: RISK / BENEFIT ANALYSIS & PRIVACY
5.1 Are there any foreseeable risks or discomforts to participants and/or groups/communities? (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests)*

YesNo
5.1.1 If Yes, please describe the potential risks and/or discomforts (physical, psychological, social, informational, reputation, legal, and/or economic).*
5.2. How will you protect the privacy of your research participant data (i.e., explain how private information—like personal identifiers—will be stored, annotated, and/or kept confidential)?*
PART 6: VERIFICATION & SUBMISSION
Checklist of Submission Documents

Informative Sheet/Consent Form(s): Standard consent form(s) should include explanation of procedures, risks, safeguards, freedom to withdraw, confidentiality, offer to answer inquiries, third party referral for concerns, and participant (and/or guardian) signature.Questionnaire/Survey Instrument/Interview Protocols: The questionnaire/survey instrument must be attached. - If the survey is being conducted verbally, a copy of the introductory comments and survey questions being asked must be attached to this form.Completion of Human Subjects Training: Human subjects training must be completed prior to submitting this form and will be verified.Recruitment Materials: Include materials used for participant recruitment such as posters, social media announcements, outgoing email announcements, etc.Other Forms as Needed: Other forms may include advertising documents, debriefing scripts, etc.
Who should receive the invoice for this review? (Leave this section blank if the Lead Investigator listed above is the billing contact)

First NameLast Name
Billing contact email (if different from Lead Investigator)
example@example.com
Verification of Details: By signing below, you are verifying the accuracy of the information enclosed in this form. *

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