Kasee Hildenbrand and Darcy Miller Institutional Review Board (IRB) > Function > Suggestions and Tips Kasee Hildenbrand and Darcy Miller

What is the purpose of IRB? To protect human subjects What the IRB is NOT? The IRB is not in existence To make judgements on your overall research design To critique your writing process To make it more difficult for you to do your research To be a road-block

Determining which IRB Review Level is Needed Exempt Expedited Full-Board

Suggestions/Tips Application information and Section 1 General Information Make sure your title contains correct information. If you use a previously submitted IRB application, make sure you look for anything that needs to be updated (assistant to associate professor, office change etc.). Be sure the correct level of review has been selected. Be sure your CITI training is up-to-date (renewed every 5 years). Make sure all additional research personnel information is correct and they have completed CITI training. Check that you have indicated a realistic study start date and duration and that this information is consistent through entire application. Often if you are going to use an outside facility for your research you will need to provide a letter of support BEFORE your application can be approved.

Suggestions/Tips Section 2 Study Description This is a section that MUST be thorough and complete…..we must be able to ascertain that human subjects rights are being protected. Change your lens for the sections Purpose – Brief overview Design – Thoughts for how you are organizing your research – specific to human subjects! Procedures – LOTS of detail here so we can verify human subjects are being protected. What will the participants do? – if you were recruiting your friend what would you tell them they need to do? How long? How often? What will happen to them?

Suggestions/Tips Section 3 Data Collection Methods Using previous versions of an IRB might leave some of the boxes checked, that are not relevant to the current study…..check for that! If you suddenly have a great idea for an addition to make your study better, go back and add it to the description and anywhere else in the application where relevant. Or if you suddenly realize something is not going to work, remove it from the application (throughout the application).

Suggestions/Tips Section 4 Confidentiality and Protection of Data The chart regarding the stages of data (collection, analysis, storage, and dissemination) across levels of confidentiality (anonymous, confidential unlinked, confidential coded, intentionally identified) is complex. Ask IRB questions if you are not clear about your data and the level of confidentiality. Provide the campus location for the data storage. If data are to be stored/transported online, there must be safety precautions (Perhaps we’ll cover safety precautions in another workshop/brown bag session)

Suggestions/Tips Section 5 Human Subject Population Be accurate, how many subjects are needed? Did you do a power analysis? Is this a pilot study? How many in each group? Adults vs children (remember human subjects can be both!) What populations are needed? If there are specifics add other You can have exclusions, but must be able to address that

Suggestions/Tips Section 6 Human Subject Recruitment This is often where individuals include different procedures and options from those addressed in previous sections of the application. In any one section of the application if a change is made, you need to review the entire application and make that change/those changes to all sections. The point of IRB is human subject protection. How they are recruited is of paramount importance, so you need to be clear and organized. There are many rules about compensation. Make sure you know them, follow them, and pay attention to the rules throughout the application and recruitment materials!!

Suggestions/Tips Section 7 Informed Consent, Parent Permission, and Assent Use the templates provided online under IRB forms. If you are going to video/audio record there must be a box were subjects check that they are giving consent for being recorded. If compensation is going to be provided, make sure that is included in the consent, and any information you will have to gather in order to process the compensation. Addendums are required if you are asking for any changes to the consent process. These must be completed and a strong rationale must be provided. Subjects’ ability to provide consent is paramount to protecting their rights. Subjects cannot be coerced and that must be VERY clear.

Suggestions/Tips Section 8 Risk and Benefit Assessment If re-using a previous application be sure to take out checked risks. Check ONLY the boxes for the risks that might occur for the application study. Level of risk is what determines how and at what level your application is reviewed. Take time to describe completely. There has to be some benefit, either to the individual or society, or there is NO point to the research question. Be thoughtful and clear when you answer these questions. The IRB focuses on risks and benefits, so spend some time here!

Suggestions/Tips Sections 9-12 If these apply to your research, they may increase the level of review. So think carefully if any of these apply. Ask questions of IRB staff. These sections often involve additional addendums, so make sure those are completed.

Other Helpful Hints If you are working with or supervising your student’s research study: Make sure you read through the ENTIRE application. Your name is associated with the study and you are listed as the PI, so mistakes and issues will be reflected upon you. Many mistakes can easily be identified by your review and will help to avoid delays in the review.

Other Helpful Hints CONSISTENCY is key. Many times if you work through the application, questions that are asked on the application trigger additions to your research thought process. However ,you must go back to the design and procedure sections (and any other section related to your changes) and update these sections with any changes. Reviewers look at your application as whole - the application, the recruitment materials and consent forms, the addendums, your instruments – every component of the application. So these must all be aligned and consistent to avoid delays in the approval of your application.

Other Helpful Hints Full Board Reviews Investigators are encouraged to attend the full board meeting to discuss their application and answer questions. By allowing the reviewers to get questions answered at this stage of the review can speed up the review process and allow for quicker turnaround. You need to contact the IRB to get on the agenda. If this is your student’s project – GO with the student to the full board meeting. Don’t let your student face the board alone. The board members are very well meaning, but it can feel intimidating to have a large group of members ask questions about the study and human subject protection.

Take Home Message The IRB’s function is to protect human subjects – so give us enough information so that we can feel confident the human subjects in your research are protected. Incomplete information makes all reviewers and the IRB examine the application in depth. Many times your research can be enhanced by the IRB reviewers’ comments, suggestions, and/or questions. That feedback may cause you to think about some aspect of your study differently – those are good things!