In order to facilitate review, the Institutional Review Board (IRB) requests that the protocols and consent forms be prepared carefully and completely according to institutional policy for review and approval of projects involving human subjects, as well as the requirements of the Department of Health and Human Services as set forth in the Code of Federal Regulations 45 CFR Part 46 and certain other related laws and regulations on the protection of human subjects.
a. APPLICATION FORM - Please provide all information requested on this form appropriate to your project, including the required signatures.
Protocol Preparation - The protocol should be prepared according to the following outline, and must include page numbers and line numbers:
a. TITLE: Name of proposal or protocol.
b. PURPOSE: Summarize the purpose of the study and clearly state the nature of the research project, as well as the hypotheses that will be tested, or the research question that is asked. The purpose statement is generally no more than one paragraph.
c. HISTORY SUMMARY: Briefly state the scientific background of the study. Include a critical evaluation of existing animal or human studies. Specifically identify the gaps the project is intended to fill. The history summary should be focused on the particular question or issue at hand, and should not be an extended review of literature. The history summary is typically no more than 3 pages.
d. SUBJECT RECRUITMENT & SELECTION: Provide the age range and gender of the subjects. Provide justification for any gender-based restriction. Include the anticipated number of subjects, the specific inclusion and exclusion criteria. If vulnerable subjects will be included (children, pregnant women, fetuses, prisoners, incompetent), provide justification of the need to use these subjects in research.
e. LOCATION: Provide the specific name of the institution or agency from which subjects will be recruited and where the research will take place.
f. DURATION: Provide an estimate of the duration of the entire study and estimated participation time for the subject. (Please note that review of the research project is required every 12 months while the study continues or at such intervals as designated by the committee after final review.)
g. RESEARCH DESIGN: Prepare an orderly scientific description of the intended procedures as they directly affect the subject. Include the number and length of time for various procedures (e.g., interviews, completing questionnaires, etc.) and frequency of repetition; randomization; any manipulation which may cause discomfort or inconvenience; doses and routes of administration of drugs; amount of blood to be withdrawn; and plans for follow-up. If there is a point at which the study procedures may be discontinued, state how it will be monitored and identified. Include measures that will be taken to treat side effects or to handle or refer problems identified during the study. If drugs or devices are administered or used, the following questions must be answered: Does the drug or device have FDA approval? What is the name of the drug or device company? If the drug or device is investigational, what is the Investigational New Drug (IND) number or Investigational Device Exemption (IDE) number? If the drug or device is marketed, is it approved at the dose level you plan, for this purpose, or by this means of administration or use? Provide a copy of the investigator brochure with background information and experience to date on the specific test article. Applications for clinical drug and medical device studies must have an original indemnification agreement attached to them with the appropriate signatures.
h. POTENTIAL RISKS: Describe and assess any potential risks--physical, social, psychological, economic, monetary, legal or other--and assess the likelihood and seriousness of such risks. If methods of research create potential risks, describe other alternatives, if any, that were considered and why they will not be used. Include effects to the participants' health or well-being of not rendering the proposed treatment. Describe procedures for protecting against or minimizing potential risks, and assessment of their likely effectiveness.
POTENTIAL BENEFITS: Assess the potential benefits to be gained by the individual subject, as well as benefits which may accrue to society in general as a result of the planned work. Analyze the ratio of the benefit to be obtained from the study relative to the risks involved. ("Minimal risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests.)
j. DATA COLLECTION AND ANALYSIS: Describe the data will be collected and the plans of the investigator for maintaining patient record confidentiality. Describe the projected plans for analysis of the data, including the tools that will be used to perform the analysis, and sample size calculation where appropriate. Show how this analysis will support or refute the hypothesis(es) or answer the research question(s). Indicate how long the records will be kept (minimum of 3 years) and where they will be housed. Please include a copy of the data collection sheets where possible.
k. CONTACT PEOPLE: Provide the names and telephone numbers of the principal investigator and any co-investigator(s).
l. FUNDING: Provide the source, nature and amount of all funding, direct or indirect, in cash or in kind.
m. INFORMED CONSENT: Describe the process of obtaining valid informed consent by addressing the following:
SUBJECT COMPREHENSION--It is important that study subjects sign a consent form they are able to understand. Please provide us with the educational level of most of the patients you are including in your study and the readability level of your informed consent. (The Flesch-Kincaid readability measure is included in many word processing programs.)
We strive to have all consent forms readable by those with a 10th grade, or lower, level of education and may require you to re-write your consent to meet this level. Readabilities may be lowered with smaller paragraphs, shorter sentences and the use of lay terms. Please see the attached consent form as one example. Additional reference materials are available upon request.
DOCUMENTATION OF CONSENT--identify the investigator(s) who are authorized to certify and document obtainment of informed consent from the subject; Each research subject must be given a copy of the signed consent.
ASSENT--if children (age 13 and over) will be subjects, how will informed assent be obtained? If the patient is an infant or minor, informed consent must be obtained from the parents or legal guardian.*
n. RESEARCH PARTICIPANT'S RIGHTS: A copy of the research participant's rights must be included, and must be given to all those who are considering participation in the study.
n. REFERENCE LIST: If any references are cited in the proposal, a reference list must be included.