I. PREPARING A NEW APPLICATION FOR IRB REVIEW The essential elements of the IRB application are:
1. Core Application - completion of A & B is required
Form A |
Form A Instructions [HTML] |
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Form B |
Click here for help |
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Form B-1 |
Form B-1 also available in [rtf] |
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Form B-2 |
Form B-2 Instructions [HTML] |
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Form C |
Form C Instructions [HTML] |
2. the research protocol or grant application,
3. consent document(s) including a valid, HIPAA compliant authorization if PHI will be involved
4. any waivers, partial waivers or alterations of consent and/or authorization that may be needed
It is essential that the entire application be prepared carefully and completely according to the guidelines on the forms and in this handbook. They become part of the official IRB records and are subject to inspection and review by various funding agencies, compliance officers and, where applicable, by federal agencies such as the VA, the FDA and DHHS.
Because funding sources have different application requirements, IRB application forms are designed to allow flexibility in the format of materials submitted for review. Certain elements are required but may vary in form. Samples of the forms are found on the IRB Forms page, and guidelines for the completion of the IRB forms follow.
Original signatures are required. If one of those whose signature is required is not available at the time of submission, please note the following: Use of a rubber stamp is not permitted. If the principal investigator is not available, a co-investigator may sign on behalf of the principal investigator. If the division chief is unavailable, a deputy or acting chief may sign. If the chairman is unavailable, the signature of a deputy chair or an acting chair is acceptable. The signature of administrative, non-scientific personnel such as the assistant to the chair, is not acceptable.
RESEARCH PROTOCOL
The investigator must supply a complete description of the research plan. In many cases, this information may be presented by referencing appropriate sections of grant applications or protocols supplied by sponsors. When required elements are not present in the grant or the sponsor's protocol, it may be supplemented by an addendum containing the additional information. When the research involves an investigational drug or device, a copy of the investigator's brochure must also be included. If an investigator's brochure is not available, please provide documentation of that fact for the record, such as a letter from the sponsor.
CONSENT DOCUMENTS
Consent documents are used in the process of obtaining informed consent to ensure all required information is given consistently to all potential subjects. It serves to document that the consent process took place to the satisfaction and understanding of both the subject and the investigator. A summary of the guidelines for the preparation of a consent document are given in the IRB Forms, while details are outlined in Section J.
CONFLICT OF INTEREST
The University of Texas Health Science Center at San Antonio, as a component of The University of Texas System and as a recipient of externally sponsored funds, has an obligation to assure that the products of its scholarly research and other endeavors are recognized as being free of outside influences. UTHSCSA has established a review procedure to identify any potential conflicts of interest or commitment, real or perceived, of its faculty members who are engaged in research and other scholarly activities. Where such conflicts of interest or commitment exist, that policy provides a mechanism for reducing, managing, or otherwise handling such conflicts.
The principal investigator must disclose his/her own potential conflicts of interest through these established procedures. The principal investigator is also responsible to assure that all the co-investigators and collaborators have also complied with the institution's conflict of interest policy.
Conflict of Interest: Means a situation where the individual has the opportunity to influence the Health Science Center's business, administrative, academic, research, or other decisions in ways that could lead to personal financial gain or advantage or could cause or appear to cause bias in the design, conduct or reporting of research or educational activities.
Conflict of Commitment: Means a situation where the individual undertakes external commitments that burden, interfere, or detract from the member's primary obligations and commitments to the Health Science Center.
Significant Financial Interest: Means anything of monetary value and includes, but is not limited to:
- Salary or other payments for services (e.g., consulting fees or honoraria);
- Equity interests (e.g., stocks, stock options or other ownership interests); and
- Intellectual property rights (e.g., patents, copyrights, and royalties from such rights)
But excludes:
- Salaries.
- Royalties or other remuneration from the Health Science Center.
- Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities.
- Income from service on advisory committees or review panels for public or nonprofit entities.
- Equity interest that does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity.
- Any other salary, royalty, or other payments expected over the next twelve months from disclosure that do not exceed $10,000.
- Any interests held indirectly through funds (such as mutual funds and pension funds) in which the Faculty Member does not control the selection of investments.