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Vanderbilt University Institutional Review Board
Application for Human Research – Expedited
Behavioral and Social Sciences



To enter your information, double-click on shaded boxes. This instruction includes both text and check boxes.

SECTION 1:
1. Study Type Information
Indicate the category of minimal risk expedited review requested. From the categories presented below, check “Yes” for the categories that you believe describe your proposed research and “No” for all others. If none of the categories apply, complete an application for standard IRB review or contact the IRB staff for instructions.
Note: If you wish to request exemption status, submit ONLY the Request for Exemption.


YOU MUST CHECK “YES” OR “NO” FOR ALL OF THE FOLLOWING:


45 CFR 46.110(f)(1):
Yes No Clinical studies of drugs and medical devices only when condition (a) or (b) is met.


a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (NOTE: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.


45 CFR 46.110(f)(2):
Yes No Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:


a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

b) from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.


45 CFR 46.110(f)(3):
Yes No Prospective collection of biological specimens for research purposes by noninvasive means.


Examples:
• hair and nail clippings in a nondisfiguring manner;
• deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
• permanent teeth if routine patient care indicates a need for extraction;
• excreta and external secretions (including sweat);
• uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
• placenta removed at delivery;
• amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
• supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
• mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
• sputum collected after saline mist nebulization.


45 CFR 46.110(f)(4):
Yes No Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)


Examples:
• physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;
• weighing or testing sensory acuity;
• magnetic resonance imaging;
• electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
• moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.


45 CFR 46.110(f)(5):
Yes No Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects: 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.


45 CFR 46.110(f)(6):
Yes No Collection of data from voice, video, digital, or image recordings made for research purposes.


45 CFR 46.110(f)(7):
Yes No Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects: 45 CFR 46.101(b)(2) except for children when the Investigators participate in the activities and (b)(3). This listing refers only to research that is not exempt.)

2. Is this proposal related/associated with any other VU IRB approved studies?
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No
Yes If “Yes,” please list IRB #(s):     



SECTION 2:
3. Location of Research

A. List all Performance Sites “engaged in research” (insert additional rows if needed).
An institution or performance site is “engaged in research” when its employees or agents (i) intervene or interact with living individuals for research purposes; (ii) obtain individually identifiable private information for research purposes; or (iii) if the institution receives a direct federal award to support such research. Please refer to the instructions for examples of what may be considered “engaged in research.” This may apply when a VU investigator collaborates with a non-VU investigator or institution, or when VU serves as a Coordinating Center. Please check all that apply and add additional sites. Each will require a letter of IRB approval. See IRB Policy I.C.
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|Check all |Name of Performance Site |FWA Holding Institution |IRB of Record |IRB Approval |
|that apply |(list all participating sites below) | | | |
| |Vanderbilt University |Vanderbilt | VU | Attached |
| |(indicate where at VU): | |Other |Pending |
| | |      | VU | Attached |
| | | |Other |Pending |
| |International Epidemiology Institute |      | VU | Attached |
| | | |Other |Pending |
| |Other, specify:       |      | VU | Attached |
| | | |Other |Pending |
| |Other, specify:       |      | VU | Attached |
| | | |Other |Pending |
| |Other, specify:       |      | VU | Attached |
| | | |Other |Pending |
| |      |      | VU | Attached |
| | | |Other |Pending |
| |      |      | VU | Attached |
| | | |Other |Pending |




B. List all Performance Site(s) “not engaged in research” (insert additional rows if needed). NA
An institution or performance site is considered “not engaged in research” when its employees or agents do not (i) intervene or interact with living individuals for research purposes; or (ii) does not obtain individually identifiable private information for research purposes; or (iii) if the institution does not receive a direct federal award to support such research. This applies if a VU investigator will be conducting research at a non-VU site or institution (e.g., when collecting specimens or information). Please refer to the instructions for examples of what may be considered “not engaged in research.” See IRB Policy I.C.
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|Name of Performance Site |If the Performance Site has an IRB, a |If the Performance Site does not have |
| |copy of the IRB approval letter is |an IRB, a letter of cooperation is |
| |required. |required. |
|      | Attached | | Attached | |
| |Pending | |Pending | |
|      | Attached | | Attached | |
| |Pending | |Pending | |
|      | Attached | | Attached | |
| |Pending | |Pending | |
|      | Attached | | Attached | |
| |Pending | |Pending | |
|      | Attached | | Attached | |
| |Pending | |Pending | |
|      | Attached | | Attached | |
| |Pending | |Pending | |








SECTION 3:
4. Funding Information
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A. Internal Funding (check all that apply):


Departmental Funds No cost study Personal Funds
Various Donors/Gifts Other, specify:      


B. External Funding (list all that apply; insert additional rows if needed):

|Agency/Sponsor |Funding Mechanism |
|      | Grant Contract |
|      | Grant Contract |
|      | Grant Contract |
|      | Grant Contract |
|      | Grant Contract |
|      | Grant Contract |

C. Is this study Industry-Supported? (If so, it is expected that the sponsor will pay the IRB new study fee of $2250 for initial review.)
No Yes If “Yes”, please indicate method of payment below.


For VU/VUMC:
Please charge my account as follows:
Center Number:       Account Number:      


Center and Account Number Pending—I will forward to the IRB when established.
Request for Waiver of IRB Fees attached—see application instructions.


For VSRH, IEI or other non-Vanderbilt sites, payment is required as specified in the signed MOU:


I have attached a check payable to the “VU IRB” in the amount of $2250.


Check requested – I will forward to the IRB when received


SECTION 4:

5. Purpose of the Study/Study Abstract
Provide a brief abstract of the study in lay language. The IRB Committees are comprised of scientists with varied backgrounds, non-scientists, and community members.


Problem:
Research question:
Methods: Focus groups will be conducted with participants recruited from . > will be conducted with 8-12 participants per group. Groups will be led by a moderator using a focus group moderator’s guide prepared for this study. The focus group will be audio recorded and the recordings will be transcribed. Trained coders will use a coding system to code the transcripts, and the codes will be analyzed to answer the study questions.




Include the expected duration of the study.
2 years


6. Description of the Study.
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Your description may include any or all of the following:
• background information;
• specific aims;
• hypothesis or research question;
• previous experience, including human and animal safety data, if applicable; and
• a critical evaluation of existing knowledge (relevant literature) about the research topic. A reference list and copies of pertinent articles can be appended if thought to be of value in the evaluation of the research by the IRB. Please contact the IRB if you need assistance in conducting a literature search.

The IRB needs to understand how this study adds to the knowledge on this topic in order to be able to judge the risks and benefits to the research participants.


Research question:

Specific Aims:



1.

Literature Review












7. Minimizing Risks to Participants/Data and Safety Monitoring Plan (DSMP)
NOTE: If VU PI is accepting coordinating center responsibilities, address that specific role in each question below.
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A. Describe how the risks to participants are minimized (e.g., screening to assure appropriate selection of participants, identify standard of care procedures, sound research design, safety monitoring and reporting).


There could be some discomfort associated with talking within a group setting. Focus group leaders will be able to respond to any distress that might arise during the discussion. The main risk is loss of confidentiality. Transcript will have any names or other identifying information removed. No names or identities will be included in any reports of the results. We will ask participants to respect each other’s confidentiality, but there is no way control what participants may or may not say about each other after the completion of the focus group.


B. Describe how the risks to participants are reasonable in relation to anticipated benefits (e.g., includes benefits to the individual as well as to human kind, indicate how the risks are justified in this population).

Focus groups are common form of data collection and pose little or no risk to the participants. There are no direct benefits to individuals. A scientific understanding of


C. Is there a data safety monitor or board/committee to review this study for safety and adherence to the study protocol? NOTE: Regardless of the response to this question, all subsequent questions in this section must be addressed.
No
Yes If “Yes,” describe the composition of the committee and their qualifications.
     

D. Provide a general description of the data and safety monitoring plan.

Recordings will be digital audio files stored on a secure server. The transcripts will remove any names or other identifying information and are kept on a secure server. The PI will verify that the files are in the appropriate places, and will instruct coder’s to only work using the secure server.


E. Describe plans for monitoring the progress of trials and the safety of participants (e.g., timing of DSM reviews and reports, planned interim analysis, etc.).
Note: DSMB reports are required to be submitted to the IRB at the time of continuing review unless the information affects the risk/ benefit profile of the study.
NA     


F. Describe plans for assuring compliance with requirements regarding the reporting of adverse events (AEs), including plans for reporting of AEs to the IRB and appropriate regulatory agencies.


While adverse events during a focus group are unlikely, any adverse event will be reported within 72 hours to the IRB.