Why do research proposals need to be reviewed by an IRB?

Lesson Transcript

Instructor: Devin Kowalczyk Show bio

Devin has taught psychology and has a master's degree in clinical forensic psychology. He is working on his PhD.

The Institutional Review Board reviews accurate information about research proposals in order to ensure that human and animal rights are in line with federal, state, local and ethical guidelines. There are certain steps that must be followed when conducting research and the researcher must meet stringent criteria before even starting an experiment. This lesson will examine the procedures and the overall importance of the Institutional Review Board. Updated: 09/23/2021

IRB Application Process Guide

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General IRB Process Overview

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The Institutional Review Board [IRB] reviews all human subjects research at The University of Texas at Austin. The IRB is composed mainly of UT faculty and meets monthly to review research proposals. The IRB reviews full board research; exempt and expedited research are reviewed "in house" by the Office of Research Support and Compliance. When a study is approved an approval letter is sent to the PI by email. Studies deemed to be greater than minimal risk [aka Full Board] are typically approved for a one-year period. PIs wishing to continue research beyond their one-year approval time period must submit a continuing review. Studies deemed to be minimal risk [aka exempt or expedited], approved after January 21, 2019 or transitioned to the Revised Common Rule, and are not regulated by the FDA or DOJ no longer have an approval end date, thus a continuing review is not required. The IRB must approveany changes or modifications [formerly amendments] to an approved study before the researcher implements such changes for research determined to be full board or expedited. For additional information regarding the IRB process, see the IRB Policies and Procedures.

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New Study submissions must include:

• UTRMS-IRB online application
• Study proposal document
• Consent forms [if applicable]
• Recruitment materials [if applicable]
• Data collection instruments [surveys, interview questions, stimuli, etc.]
• Other forms or documents utilized with human subjects

Continuing Review submissions must include:

• UTRMS-IRB continuing review application

Modification submissions must include:

• UTRMS-IRB modification application
• Revised IRB proposal or other documents impacted by the proposed research modification
• Newly developed documents that support the proposed research modification

Forms, templates, and guidance documents are available at the IRB Forms page. Study-specific materials will need to be provided by the researcher.

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The IRB research proposal is a description of your study plan and must be submitted in the required format [see templates at the link below]. The research proposal describes the protocol you will follow and can include: the research hypothesis, study background, design and methodology, data analysis, study procedures, details about the subject population, inclusion/exclusion criteria, recruitment, informed consent process, benefits, risks, privacy and confidentiality and compensation and costs.

It is important to design your research protocol to account for risks to human subjects. The study proposal is supplemented by recruitment materials, consent forms, and data collection instruments. Once you have written your proposal and developed the supplemental materials, the next step is to get IRB approval. IRB approval is required before you begin conducting research. Visit the IRB Submission Forms page for proposal templates and supplemental proposal forms to complete as needed.

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Research conducted upon private-premises other than the University of Texas at Austin requires approval from that site to conduct the proposed research.You can upload a copy of the site letter if the site or sponsor requires documentation of site approval to be provided to the IRB.The site letter must grant permission for the researcher to conduct research at that site. The letter should be signed by a party responsible for research and/or the conduct of similar activity at the site. For example, school district letters are typically signed by the superintendent for schools in that district. Letters from private institutions should be signed by a director, executive, owner, or other appropriate official.

If you are conducting research at a Seton facility, the UT IRB requires the Seton Site Approval Tool [SAT] email confirmation to be uploaded as part of your application. You can attach this confirmation in the “Other Documents” section on the “Local Site Documents” page of the SmartForm in UTRMS-IRB.

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Informed consent and confidentiality are critical to the process of collecting data from human participants. Please refer to the UT IRB Policies and Procedures, Section 6: Informed Consent for additional information. Except as described in Section 6.7 Waiver of Informed Consent and Waiver of Documentation of Consent in the UT IRB Policies and Procedures, investigators may not enroll human subjects in research unless they have obtained the legally effective, written, informed consent/authorization of the subject or the subject's legally authorized representative[LAR]. Investigators are responsible for insuring that the subjects, or their representatives, are given sufficient opportunity to consider whether or not to participate and must seek to avoid coercion or undue influence. Information given to potential subjects or their representatives must be in a language that is understandable to the subject or representative. No process of obtaining consent/authorization may include exculpatory language through which subjects waive any of their legal rights or releases or appear to release the investigator, sponsor, or institution or its agents from liability for negligence. The elements required in the informed consent document can be found in Section 6.2 Elements of Informed Consent in the UT IRB Policies and Procedures.

Occasionally, the institutional setting in which the consent/authorization is sought will pose the possibility of coercion. Conducting research at institutions that provide services to subjects may be perceived as implying that continued service is dependent upon participation in the research. Students in the educational setting may be concerned that refusal to participate will affect their grades. These institutional pressures should be addressed in the research design. The protocol must adequately preserve the right to refuse participation. See the UT IRB Policies and Procedures for more information and IRB Submission Forms for informed consent template.

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Frequently proposals confuse confidentiality and anonymity. Anonymity means "unknown." This means for subjects to be anonymous the researcher must not be able to identify them. Confidentiality occurs when the subjects are identifiable but the researcher does not reveal their identities. Whenever possible design human subjects research to be anonymous as this poses the minimal risk to research subjects.

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Some academic areas have a departmental review processes for research submitted to the IRB. You must follow all departmental requirements for review and approval, if applicable. If you have questions about the rules and procedures for departmental review or the applicability of this information to your submission, please contact your department.

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A faculty sponsor, who is eligible to serve as a Principal Investigator [PI], is required for all students conducting human subjects research and should oversee the conduct of student conducted research. You and your faculty sponsor are responsible for human subjects protections. The faculty sponsor is typically your dissertation or thesis chair, however, this is not always the case. It is important to remember to choose a faculty sponsor which works well with you. Your sponsor will provide valuable recommendations about experimental designs aimed at reducing the risk to human subjects.

In the UTRMS-IRB system, the faculty sponsor will be listed as the Principal Investigator and the student investigator should be designated as the PI Proxy. The PI Proxy will be able to submit actions in the UTRMS-IRB system.

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The guidelines outlined below are meant to assist investigators in determining a reasonable amount of compensation that can be given to research participants and also place some boundaries on what is and is not “reasonable.” The “reasonableness” of a particular sum of money or other form of payment should be based upon the time involved, the inconvenience to the subject, reimbursement for expenses incurred while participating, and should not be so large as to constitute a form of coercion.

During the initial review of a research protocol, the IRB is required to review both the amount of compensation proposed and the method and timing of disbursement to assure that neither are coercive or present undue influence. The following are some additional guidelines:

1. Any compensation should not be contingent upon the subject completing the study, but should accrue as the study progresses.
2. Unless it creates undue inconvenience or a coercive practice, compensation to subjects who withdraw from the study should be made at the time they would have completed the study, had they not withdrawn.
3. Compensation given as a “bonus” or incentive for completing the study is acceptable to the FDA, providing that the amount is not coercive. The IRB is responsible for determining if the incentive amount is not so large as to be coercive or represent undue influence.
4. The amount of compensation should be clearly set forth in the informed consent/authorization document.

Also note: The University of Texas at Austin Institutional Review Board discourages thepayment of finder’s fees[monetary or in kind] in any form, due to the potential that such a practice could be perceived as coercive and bordering on unethical research subject recruitment. In addition, several professional associations and groups have stated that this practice is unethical.

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The Office of Research Support and Compliance & Compliance notifies PIs 90, 60, and 30 days prior to the study expiration date. These emails are automated and only warnings about the upcoming expiration date. Suspension and termination emails are also generated and emailed by UTRMS-IRB.All emails are sent to the email address on file in Workday.

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A PI closes their study on or before the study expiration date. Closing a study requires PIs to submit a closure report. A study should be closed when human subject interactions have ended and subjects are not identifiable. If a risk to confidentiality remains despite all research being concluded [i.e. subjects can be identified in your data as you analyze and write] then you should not close the study.

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PIs may bring forward to the Committee, IRB Chair, Director of the IRB, Assistant Director of the IRB, IRB Operations Manager or IRB Analyst concerns or recommendations regarding the human research protection program, including the IRB review process. To voice feedback, please email.

Do I need to have Institutional Review Board [IRB] approval when I submit a proposal that plans to use human subject data?

IRB application can be submitted post proposal submission. MPRC also helps with IRB application preparation.

No you do not need to have IRB approval prior when you submit a research proposal. The fact that you plan to use human subject data must be included on both the internal routing form and the sponsor’s form pages. If the IRB application still needs to be submitted and approved, it is noted that approval is “pending.” The IRB application can be prepared following the submission of the proposal. Note: the IRB approval process can take several months. The university can not accept an award until this process has been completed. MPRC staff can assist with your IRB application and submission.

IRB Website: //www.umresearch.umd.edu/IRB/