IRB Information

Dr. Hugh Gladwin, IRB representative for SJMC, GSS, AADS, SEAS, etc.
gladwin@fiu.edu

This page covers IRB application procedures for faculty and students working on research projects. The information here applies mainly to IRB applications for surveys or qualitative research involving interviews with adults where no potentially harmful questions are asked and records identifying individual respondents are not kept. If you are doing surveys that ask questions of children, questions that could get people in trouble, or anything other than survey or focus group questions where people's identities are being kept confidential, you should talk to me or another IRB representative first.

If you want me to review your application, please let me know by email and then email me your forms as attachments when they are ready. After I have reviewed them and let you know about changes we can discuss getting the forms signed. Please do not mail me paper forms or leave them in my office. Also email is much better for communicating with me than my office phone. When I am ready to get your form HSF_A signed, I will ask you to fax it to me at a number where I can get it as a PDF.

Often I have a number of applications to process and FIU has no electronic system yet to keep track of them, so you have to remind me by email every few days if you don't hear from me after you have sent me the forms. Once I have sent in my review of the application to the IRB coordinator, you (or your faculty adviser if you are a student) will be notified, not me.

Steps to complete for the human subjects approval process

1. Needed only if you are not sure whether your study needs IRB review: Download IRB form A-1: from here This is not the "official" application, but is a form designed to determine if you are doing work that requires IRB approval. If the results of your study are going to be presented to or given to a client, meeting, or publication outside of FIU after they are completed you may skip doing this form since you know you will have to apply for review (form A next).
   
   
2. Download IRB form A from: http://research.fiu.edu/compliance/humanResearch/humanForms.html, IRB APPLICATION (FORM A) - For Initial IRB Approval Submission Only, (MS Word form) and fill it out. If you are a student your advisor has to sign the form along with you. Normally you would not check any of the categories under "special population identifiers" unless your study is specifically directed toward one of these groups. Make sure the start date is after your application will be processed. For exempt applications you should allow at least two weeks. If you start any part of the research that involves human subjects before the application is approved and processed by the IRB you will not be allowed to use the data you collect.
   


3. Complete an IRB research proposal: IRB Proposal Template - Proposal Outline that Must be Submitted with Form A, IRB PROPOSAL TEMPLATE - Proposal Outline that Must be Submitted with Form A (download Word doc to fill in -- for a copy of the form with very detailed instructions click here). For a project involving interviews and/or focus groups or other qualitative work this is usually no more than two or three pages long. It should include brief paragraphs under the headings below. An example of a very simple proposal that would be judged exempt can be seen here -- this is about the minimum length needed to cover the basics. Note that many or most proposals will have to be somewhat longer, since it is important that the reviewer knows clearly how you will handle confidentiality, consent, etc.
• RESEARCH OBJECTIVES: Very brief statement of what you expect to accomplish.
  
• SUBJECT RECRUITMENT: How you will get people to participate; who they are, etc.
  
• METHOD AND PROCEDURES: Brief statement of methods.
  
• BENEFITS: Who will benefit from the study. Will the people you interview benefit? Fine to say there is no benefit to them other than perhaps an interesting conversation.
  
• RISKS TO SUBJECTS: For the kind of project discussed above there probably will be "no appreciable risk to subjects beyond what would be encountered in daily life or a conversation." If you think there is more risk than that, describe it and what you will do about it in your application, in detail. Do not say that your project has no risk--nothing in life is without some risk.
  
• INFORMED CONSENT: if you can say something like this, do so: "The research presents no more than minimal risk and involves voluntary interviews, procedures for which written consent is not normally required. Potential respondents can readily decline to be interviewed if they do not want to be. This wording will be used to verbally describe the research to them: [insert how you will begin the interview]". It needs to be clear you are asking them to do the interview, and they can decline by saying "no." (if you do this, on form A, check the first box under REQUEST FOR WAIVER OF WRITTEN CONSENT DOCUMENT). This kind of brief consent can only be used for research that is judged to be exempt.
  
• CONFIDENTIALITY OF DATA: No problem if you are not going to record and keep identities (names, phone numbers, etc.) of interview subjects after the interview, just say so. If you are going to keep identifying information while the study goes on (for example, to be able to get in touch with respondents to check an answer) and if the identifying information contains nothing potentially harmful, state that and also describe the locked and secure manner you will keep the identifying information and how you will make sure it is not in the data set after the interviewing is completed.
  


4. Complete human subjects training module. Read about it at this FIU site. Then go to this NIH site to take the course.
   When you complete the course print out the certificate. Keep the original and add a copy to the application.
   Your advisor will also have to include a certificate.
   You only have to go through this process once; you can make a copy of the certificate for any future IRB applications. Please keep it where you won't lose it.
   


5. Include a copy of your questionnaire and/or any other research materials. If you are doing qualitative research or if you will be interviewing people as part of preparing a questionaire be as clear and complete as you can about what will be asked and/or observed in a statement you attach. In the latter case you may be asked to submit a copy of the final questionniare when it is ready.
   If you are a graduate student who is applying for dissertation or thesis research and you have submitted a 5-page proposal to the University Graduate Office, you need to include that too.


6. Email me the Form A, research proposal, and questionnaire and/or any other research materials as attachments, so I can review your application and let you know if changes need to be made. For exempt proposals once I have done my review and everything is signed it usually does not take more than a week or so for you (or your advisor if you are a student) to get the approval letter. Again, please do not mail or deliver any paper forms to me.
   


7. If you have more questions they may be answered via links on this page.