A fully completed IRB Application.

2. All applicable attachments, including consent forms, surveys, interview guides, instruments, recruitment flyers, and letters of authorization from each institution involved other than the UGA.

3. For more information, see Section II of the Guidelines.

Application forms are available on the web.

It is always a good idea to submit your application as soon as possible. You may submit before obtaining written approval from other institutions. Your application will go through the review process without the letter(s) of authorization; however, the IRB cannot give final approval until all letters are on file in the HSO.

Yes. New IRB applications, continuing reviews, and amendments may be sent as email attachments to irb@uga.edu.  However, all of the following criteria must be met to qualify for an electronic submission.

• Total number of pages for the complete application must be 100 pages or less.
• Application and all supporting materials (e.g., consent document/s, instrument/s, letter/s of authorization, etc.) must be submitted in electronic form (i.e., HSO cannot accept an application via this method if some materials can only be submitted as paper copies).
• Signature page/s must be sent by mail, fax (706.542.3360), or scan to email with the electronic submission.

Word format is preferred except for other documents (e.g., authorization letters, instruments) that must be scanned and attached as a pdf file.

No. The cover page may be legibly handwritten. All other pages must be typed on the application form or prepared on computer by the applicant following the designated format. Handwritten applications will be returned to the researcher or faculty advisor without being reviewed. The entire application is available on the web and can be completed before being printed.

The Institutional Review Board strives to review and approve every application as quickly as possible, but the process may take from a few days or weeks, depending on the individual project and the work load of the Human Subjects Office and the IRB. The researcher has a significant influence on the approval time, i.e., a complete and well-prepared application, and a prompt response by the researcher on any request for modifications and/or additional information will help speed the approval process.  For more detailed information regarding review levels and approximate processing times see Section III of Guidelines on time considerations for review.  It is the researcher's responsibility to submit an IRB application as far in advance as possible in order to meet research deadlines.

Yes, you may call the Human Subjects Office at 542-3199 to learn the status of your application after you have submitted an application. You may learn where your proposal is in the review process. If any changes are required, you will receive an email detailing the changes. Your study can only be approved after all the changes have been made and submitted. When your study is approved you will receive written notification from the Human Subjects Office. Do not begin data collection until you receive written approval from the HSO. If you do not hear from the personnel at the Human Subjects Office, it is your responsibility to inquire about the status of your application before you begin your data collection.

Yes, the HSO personnel are pleased to give advice and guidance. Please feel free to call us at 542-3199 or e-mail at IRB@uga.edu if you have questions. You will not be penalized for incomplete or incorrect answers on your application; you will be asked to correct them.

The IRB Chairperson will be pleased to meet with you, but we recommend that you make an appointment. Please call 542-3199 for an appointment.

Some projects may meet the criteria set forth by the federal regulations for administrative (exempt) or expedited review, and will not require full IRB review. All research that involves more than minimal risk and/or does not clearly fall into one of the administrative (exempt) or expedited categories will be reviewed at a convened meeting of the IRB.  The vulnerability of the targeted population is also a determining factor in the type of review. Please refer to Section I of the Guidelines for a detailed explanation of the different levels of review.

Generally, normal educational practice means activities that would occur in a given educational setting regardless of whether or not a study was being conducted. Such activities must not be disruptive to the normal classroom routine and do not require students to undertake any tasks specifically designed for a particular project.

Yes. If students are required to participate in the subject pool you must make clear the terms under which they will receive credit for full or partial participation, their freedom to not take part in all or any part of the research, and the alternative ways in which they might fulfill their course requirements. In all human-subject activities where sensitive issues of personal behavior, depression, addiction, substance abuse, dietary disorders, suicidal tendencies, sexual disorders might be revealed, you must include on the consent form sources of professional consultation and care. In addition, efforts must be made to insure that all participants are legally adults.

Because many human subject activities, particularly in Psychology, are conducted in the context of both teaching and research, you must provide the subjects with an oral or written explanation (debriefing) of the nature, design, and implications of the project even if deception is not a part of the experiment. A debriefing script or form must be submitted with the application as an attachment.

Yes, if the benefits outweigh the risks to the subjects for participating in such a study, and if the researcher provides a compelling scientific justification for such experimental manipulation. For research where deception or misrepresentation is involved, the subjects must receive an explanation (a debriefing) about the nature of the experiment and why such manipulation was critical to its success. Such a form should be included with the materials submitted for IRB review and approval. All research that involves deception must be approved by the HSO.

No. All research involving human subjects must be reviewed and approved by the IRB before the research can be conducted.

Any extramural study may be terminated/suspended by the IRB, which could lead to the loss of funding. Graduate students who begin human subjects research before the IRB has approved the research may be denied permission to graduate by either their department or by the Graduate School. For additional information refer to Section XI of Guidelines.

Yes. To ensure that the UGA's researchers comply with federal and university regulations, it is important that the University, through the IRB, be aware of where and by whom such activities are being done, even if conducted in a foreign country. In many cases the researcher must provide written authorization from that locale.

Yes. The Board is required to conduct continuing reviews of applications at intervals appropriate to the degree of risk, but not less than once a year. The Board also has the authority to observe or have a third party observe the consent process and the approved activities. Most continuing reviews are conducted through a questionnaire reporting the status of the project, completed by you and returned to the HSO. For additional information refer to Section IX of Guidelines.

Yes. Any changes to your protocol must be reviewed and approved by the Board. In most cases, however, this can be done quickly through an expedited review by the IRB chair and/or selected members of the Board. For additional information, refer to Section V of Guidelines on Researcher Responsibilities.

The term "Identifier" refers to any information that could be used to match the data with the individual subject. Some examples are the subject's full or partial name, initials, social security number, and phone number.

Yes. The subject must be informed that the data is being collected through such recordings unless approval for deception has been granted by the IRB. Consent forms must describe specifically who will use these recordings, how they will be used, for what purposes, how long they will be stored, and how they will be disposed of at the end of the study. Use of such data for other purposes must be disclosed and permission obtained for subsequent use in a special part of the consent.

The IRB is responsible for reviewing and approving your application to use human subjects, but is not responsible for meeting research deadlines and cannot predict or guarantee approval dates. Fill out forms accurately and completely, and submit all applicable attachments as early as possible to meet your deadlines.

Carefully read all of the Guidelines for Researchers.

1. Complete each section of the application form fully and accurately. Leave no blanks in your application; type and answer all questions. If a question is not applicable, answer "not applicable." This includes the question concerning funding. If the IRB must call or write for additional information, or wait for a revised copy of your application, review of your study will be delayed. Be sure the phone number and/or e-mail address you provide on the application form is one where you can be reached during the day or a message can be left for you. Since results and status of IRB reviews are usually communicated via email, please use your UGA email account at all times to avoid any misdirected communications. If you do not understand an item in the application form, call the Human Subjects Office at (706) 542-3199 or e-mail at IRB@uga.edu.
   
2. Carefully write your consent form(s) or cover letter(s). Tell the research participants as much as possible depending on their level of understanding and without compromising your study. If you cannot give them all the details, let them know you are withholding certain information, and that you will provide a full explanation at the end of the study. Do not make your final copies until the IRB has approved your research.
   
3. Don't forget to sign the application form. The assurance and signature of the Primary Investigator (PI) is required on the second page.
   
4. The IRB and its staff work very hard to review and approve your projects in a timely manner as possible. However, there are instances when they are unable to reach you to discuss some point in your study. If you do not receive any word from the Human Subjects Office within a reasonable period of time (4 weeks), please call the office at 542-3199 or e-mail at IRB@uga.edu to learn the status of your study.