IRB Protocol Submission

INNOVACORE Institutional Review Board (IRB)

Application for Review of Research Involving Human Subjects

Submitted under 45 CFR 46 and, where applicable, 21 CFR 50 and 56

Instructions. Complete every section that applies to your study and click a box to select it. Section 3 asks you to request one level of review. The IRB makes the final determination of the review level and may assign a different level than the one requested. Submit this form with all required attachments listed in Section 10. Incomplete applications will be returned without review.

Institutional Organization & Registration #: IORG0012140

Federal Wide Assurance #: FWA00034338

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1. Administrative Information

IRB Protocol No. (office use)

Date Submitted

Principal Investigator (name, degrees)

Department / Institutional Affiliation

Telephone

Co-Investigator(s)

Faculty advisor (if PI is a student, resident, or fellow)

Study coordinator / Primary contact

Human subjects protection training (e.g., CITI) completed by all key personnel; date of most recent completion

Type of Submission

New Study
Continuing Review / Renewal
Modification or amendment to an approved study

2. Study Information

Full Study Title

Short Title

Funding Source / Sponsor

Grant or Contract No. (if any)

Anticipated Start Date

Anticipated Completion Date

Performance Site(s)

Other IRB(s) reviewing this study

Is this a multi-site study? If yes, identify the IRB of record

3. Requested Level of Review

Select the single level of review you are requesting, then complete the matching part (3A, 3B, or 3C). 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 (45 CFR 46.102(j)).

Exempt Review (45 CFR 46.104(d)). The research involves no more than minimal risk and falls entirely within one or more of the eight exempt categories in Part 3A. Exempt studies are not subject to continuing review, but changes that could affect the exempt status must be submitted before implementation.
Exempt Review (45 CFR 46.110; 21 CFR 56.110). The research involves no more than minimal risk, and every procedure falls within one or more of the expedited categories in Part 3B. The review is conducted by the IRB Chair or a designated experienced member.
Convened (Full) Board Review (45 CFR 46.108(b); 21 CFR 56.108(c)). The research involves more than minimal risk, or it does not qualify for exempt or expedited review. The study is reviewed at a convened meeting at which a majority of members, including at least one nonscientist, are present.

3A. Exempt categories (complete only if requesting Exempt Review; select all that apply)

Category 1: Research in established or commonly accepted educational settings that specifically involves normal educational practices and is not likely to adversely affect students' opportunity to learn or the assessment of educators.
Category 2: Educational tests, survey or interview procedures, or observation of public behavior, where the information is recorded without identifiers, disclosure would not place subjects at risk, or the IRB conducts limited review.
Category 3: Benign behavioral interventions with adult subjects, with data collected through verbal or written responses or audiovisual recording, where the subject agrees to the intervention and information collection in advance.
Category 4: Secondary research use of identifiable private information or identifiable biospecimens for which consent is not required, where the sources are publicly available, the information is recorded without identifiers and with no contact or re-identification, the use is regulated under HIPAA, or the research is conducted by or for a federal agency.
Category 5: Research and demonstration projects conducted or supported by a federal department or agency to study, evaluate, or improve public benefit or service programs.
Category 6:Taste and food quality evaluation and consumer acceptance studies.
Category 7: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use, for which broad consent is required (limited IRB review).
Category 8: Secondary research use of identifiable private information or identifiable biospecimens for which broad consent has been obtained (limited IRB review).

Exemptions do not apply to research involving prisoners, except research aimed at a broader population that only incidentally includes prisoners (45 CFR 46.104(b)(2)). With children, Category 2 applies only to educational tests or to observation of public behavior in which the investigator does not participate, and Category 3 does not apply (45 CFR 46.104(b)(3)). Research involving FDA-regulated products is generally not eligible for exemption under 45 CFR 46.104.

3B. Expedited categories (complete only if requesting Expedited Review; select all that apply)

Category 1: Clinical studies of drugs and medical devices only when an IND is not required, or an IDE is not required, or the device is cleared or approved and used according to its labeling.
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture within the volume and frequency limits set by OHRP and FDA for healthy adults and for other subjects.
Category 3: Prospective collection of biological specimens for research purposes by noninvasive means.
Category 4: Collection of data through noninvasive procedures routinely employed in clinical practice, excluding X-rays or microwaves and procedures involving general anesthesia or sedation.
Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for nonresearch purposes.
Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 7: Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methods.
Category 8: Continuing review of research previously approved by the convened IRB, where enrollment is closed, and only long-term follow-up or data analysis remains, or no subjects have been enrolled.
Category 9: Continuing review of research not conducted under an IND or IDE, where the convened IRB has determined that the research involves no more than minimal risk and no additional risks have been identified.

Expedited review may not be used where identification of subjects or their responses would reasonably place them at risk of criminal or civil liability or damage their financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections are in place. Categories 8 and 9 apply only to continuing review.

3C. Reason for Convened Board Review (complete only if requesting Convened Board Review; select all that apply)

The research involves more than minimal risk to subjects.
The research involves an investigational drug, biologic, or device requiring an IND or IDE, or a significant-risk device.
The research involves vulnerable populations requiring additional determinations under 45 CFR 46 Subparts B, C, or D.
The research does not fit any exempt or expedited category.
Other (explain below).

3D. Justification for the level of review requested.

Explain briefly why the study qualifies for the level of review and the category(ies) selected above.

4. Lay Summary

In plain language (no more than 250 words), describe the purpose of the study and what participants will do.

5. Study Population

5.1 Will the study include any of the following populations? (select all that apply)

Children or minors (Subpart D)
Prisoners (Subpart C)
Pregnant women, fetuses, or neonates (Subpart B)
Adults lacking capacity to consent
Students, trainees, or employees of the investigator or sponsoring institution
Economically or educationally disadvantaged persons
Persons with limited English proficiency
None of the above

5.2 Additional safeguards for the populations selected above.

6. Recruitment and Informed Consent

6.1 Consent process (select all that apply)

Written informed consent (45 CFR 46.116; 21 CFR 50.25)
Parental permission and child assent (45 CFR 46.408)
Consent by a legally authorized representative
Request for waiver of documentation of consent (45 CFR 46.117(c))
Request for waiver or alteration of informed consent (45 CFR 46.116(f))
Not applicable: exempt research, with study information provided to participants

6.2 Compensation or incentives.

State the amount, form, and payment schedule, if any.

9. Conflicts of Interest

9.1 Does any investigator or key study personnel have a financial or other conflict of interest related to this study?

Describe the conflict and the management plan below