Researchers requesting permission to conduct research involving human subjects within or outside of Brigham Young University must submit an application to the Institutional Review Board for Human Subjects.

APPLICATION

The application should be typed in 12pt font, single spaced, page numbers, headers/footers with current date/revision date and appropriate headings. Two copies of the application should be unstapled and brought to the IRB office. The protocol application is located on the Forms page. All protocol applications should include:

1. Parts A, B, and C. Part B is intended to be a brief (3-4 lines) description of the research. The boxes can be expanded but anything more than a few sentences is not necessary.


2. Part C—Signatures of the PI and faculty mentor, for students, will need to be included before a review will take place. Applications for the purpose of theses or dissertations will need to obtain the signature of the Committee Chair and requires the date of approval before submission to the IRB.


3. Part D—1-9, should be 5-7 pages, single spaced (not including instruments, consent forms, etc.). Summary of Proposal Research should include a more detailed, thorough response to each section. In order to assess the risk/benefit ratio of the study, provide detailed information for each section. Proposals lacking detail will be returned to the PI for completion.


4. Appendix E—Consent document or script for oral consent. If you wish to alter or waive any element of signed informed consent, you must fill out the Request for Waiver or Modification of Consent also found on the Forms page of the website; include it with your application.


5. Appendix F—All Questionnaires, Instruments, Surveys, Interview questions, etc.


6. Appendix G—IRB Tutorial Certification at the following link, https://irbtutorial.byu.edu/. Login and read module two, “Investigator Responsibilities and Informed Consent.” Once you've completed the module, you must print off your certificate and attach it to your IRB application. ORCA cannot verify completion unless you provide a certificate. Required for first-time faculty submissions and all student submissions. Certificates will need to be submitted for all researchers listed as the principal and co-investigators.


7. Appendix H—Other supporting documents such as letters of support from other institutions or universities, grant applications, vitae, etc.

Application Details (Instructions - Not inclusive)

Part A: Application Information

1. Title of the Study. The title of the study should be informative and relevant to the research being conducted.


2. Principal Investigator. The PI should be the person mainly responsible for the research. For student submissions, please include your faculty advisor as the co-principal investigator.

Part B: Research Study Synopsis

1. Short Study Description: This should be brief describing the study in general. Please do not include more than a few sentences; more detailed responses are requested in Part D.


2. Study Procedures:
1. The duration of the subjects’ participation should be just their involvement in the study, not necessarily the total duration of the project.


2. If participants are followed after their participation, a short description of how they will be followed and what data will be collected during that period.


3. The number, duration, and nature of encounters should include all interviews, surveys, participation time, etc.


4. Therapeutic research includes study of the efficacy of a therapeutic or diagnostic assessment method when the intervention is designed solely to enhance the well-being of the participant who is seeking a health benefit.


5. Non-therapeutic research has no likelihood or intent of producing a diagnostic, preventative, or therapeutic benefit to the participant.

Part D: Summary of Proposal

Please address these areas in a concise and informative manner. Use the headings noted below. Even if you have addressed an issue or particular information in another section of the application, it must be described here in more detail as well. Protocols that are incomplete or do not follow directions will significantly increase review and approval time.

1. Specific Aims or Hypothesis. What is the purpose of this research project? If the research is largely descriptive in nature, the researcher should note the key concepts or constructs for the project. For hypothesis, briefly state the hypothesis or questions to be tested. This should logically and clearly be derived from the summary of background and significance.


2. Background and Significance. This section should contain a brief review of appropriate literature with references and a statement of how the proposed project will relate to and differ from what has been accomplished previously.


3. Description of Subjects. Describe subjects and the specific criteria that will be used to include or exclude persons from taking part in the study. If vulnerable subjects are included justify their inclusion. Describe how subjects will be recruited into the study and how consent will be obtained.


4. Confidentiality. Detail how confidentiality will be maintained. This includes a description of the secure storage of data (including notes, tapes, etc.) gathered in the study, what will happen to this information after the study (i.e., the tapes will be destroyed, materials will be donated to an archive, etc.), and who will have access to the data. Many disciplines require that original research materials be kept for a specific period of time. If this is the case, please specify the duration of storage and how those materials will be securely stored during this time period.


5. Method or Procedures. Describe in detail all methods and procedures used to collect data from subjects. Include a detailed description of all instruments, questionnaires, surveys, interview questions to be used and include a copy of the tools in Appendix F. Any interventions, drawing of blood, or other procedures should be described including who will be doing the procedure and their qualifications. Be very specific about methods for obtaining the data. This description should include a complete overview of subject selection (sampling methods), data collection protocols and data processing procedures.


6. Data Analysis. Describe data analysis in relation to each question/hypothesis. Be very specific about the method of analysis. It must be clear how data will be analyzed to address each question/hypothesis stated. If the study is largely descriptive, note that in this section.


7. Risks. All reasonable risks or potential injury to the participants should be listed (discuss likely physical, psychological, social and economic harms). Any questions or situations that could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability, or reputation must be listed. Deception in an experiment or research project may result in emotional or psychological distress, particularly if the subject is misled about their performance or the consequences of their decisions in the project. Some research designs may make a breach of confidentiality more likely. Describe protection measures used and method(s) of mitigating or eliminating any potential adverse reactions to the data collection techniques or any potential breaches of confidentiality. In deception studies where the subjects are mislead about their performance or behavior, describe the debriefing procedures you will use. If risks are minimal, the subject should be informed that there are minimal risks to participation in the study.


8. Benefits. All benefits to the subjects and to society should be listed. If there are no direct benefits to research subjects, state this and then describe the benefits to society.


9. Compensation. Describe compensation to subjects, if any. This may include money, gift certificates, vouchers, drawings, and/or extra credit. Detail the method of providing the compensation, if and how it will be prorated, and when it will be given. If extra credit is offered by the teacher, describe the fair alternative to receive the same amount of extra credit for those who choose not to participate in the research study.


10. References.This should include your own research and the literature citations of the research already done in this area as well as any citations made in the protocol. If your references do not include work you have done in this area, you may include references that demonstrate your research in a related area. For students who do not have research references of their own, please include pertinent references of your faculty mentor.


11. Qualifications. Describe the duties and qualifications of all those involved in the research. This includes all procedures described and the analysis of data. Qualifications should be described in detail. Vitae may also be attached. The IRB will not approve research unless researchers, and those that assist them, are appropriately qualified for their roles in the study. Please be sure that vitae are no longer than 3 pages per individual.

Appendix E. Consent Form. Please include all consent and assent documents. If a waiver/alteration of signed consent is being requested, please attach the form with the script that will be used to obtain consent. In most cases the informed consent should be only one page in length. When a multi-page consent form is used, please include page numbers at the bottom of the page and an area for initials: For example, page 1 of 2 _____ (initials).

Appendix F. Questionnaires, Surveys, Interview Questions, discussion questions (focus groups), etc. that subjects are expected to complete or respond to.

Appendix G. IRB Online Tutorial needs to be completed prior to IRB proposal submission for first-time faculty submissions and all student submissions.

Appendix H. Other Supporting Documents.