Application & Review Process

You need to list all investigators and anyone directly involved with your project in your application. Franklin research team members should be added using the 'Find People' tab in the Cayuse application. If you cannot locate a Franklin-affiliated person in 'Find People', please email the IRB Office.

External co-investigators and key personnel can be added to your application manually. You will need each individual's first and last name, affiliation name and address (university, organization, company, etc.), email address, and phone number.  

Note that the Principal Investigator (PI) must be a Franklin University employee or doctoral candidate.

Doctoral candidates will identify their dissertation committees in this section.

There are different types of IRB review. The IRB will make the final determination as to which category of review a protocol requires; however, PIs should read through the IRB review categories and have some idea of whether their research is exempt or non-exempt (i.e., requires expedited or full board review). This distinction will determine the application you complete in Cayuse. Review research review categories here.
 

This captures basic information about why, when, where, and how you are conducting your study: 

• Purpose of the study
• Study dates
• Performance sites (actual location(s) where you will collect data for your study)
• Data collection plan
• Funding

Questions about the study population help the IRB to understand who participants are and how they will be used in the study. This section captures details about your study that enables the IRB to assess risk and to ensure the rights and welfare of human subjects are protected in research.

You will be asked to provide information about the following: 

• Participation requirements
• Participant vulnerability
• Risks and benefits assessment
• Eligibility criteria
• Recruitment, esp. access
• Detailed consent and assent processes
• Compensation

The IRB encourages all investigators to use the informed consent templates provided on this website. Issues with the consent document often include the following:

• Missing criteria: There are a number of required criteria for informed consent documents detailed in the federal regulations (45 CFR 46.116). Make sure your consent documents contain all relevant components of consent. Check out the federal requirements for additional details. 
• Copying and pasting from the research proposal: A consent document should contain easily understandable language (aim for a sixth grade reading level) that anyone can follow. Think about your audience and what they should know or would want to know when deciding if they want to participate in your study. For example, your consent document should not contain a literature review that was copied from your proposal. It should not contain acronyms, theoretical models, or technical jargon most participants will not understand. The consent document should be concise and provide relevant information that is presented in a comprehensible way to participants. 
• Tailoring the template and not deleting what does not apply: The templates are for all investigators to use, and some of the content will not apply to your study. Make sure you delete the parts that are not relevant to your study. For example, delete everything about video recording if you are not video recording as a data collection tool. 
• Gaining consent to audio and/or video record: If you want to record an interview or another activity as part of your data collection strategy, you must first have permission from each participant. Your consent document should clearly give participants a choice and request that individuals consent specifically to recording. 
• General editing: Anyone who participates in your study deserves a well-written, thoughtful, complete, grammatically correct consent document. Make sure you proofread it carefully. 

If you are conducting research at an outside institution or organization of any kind, or if you are otherwise relying on the cooperation of another institution, organization, agency, business, and so on to assist you, you must submit a letter of support with your IRB application. Ensure all required components are contained in your letter. You may review the guidance here.

There is nothing wrong with using material that comes directly from the research proposal as long as what you copy and paste answers the question and can be understood by IRB reviewers and analysts. Oftentimes, copying and pasting does not address the specific question in the application.

Remember, the IRB likely does not have prior knowledge of your study. Principal investigators need to provide information written in a way that is clear, detailed, thorough, and understandable to IRB reviewers and analysts who assess the protocol. Written responses within the application should be contain complete, grammatically correct sentences that fully answer the question.

An IRB analyst or reviewer will walk through a project from start to finish to assess risk and to determine if adequate protections for human participants in research are in place. An analyst or reviewer will red flag gaps in that process and ask for more information.

Example: If an organization grants an investigator access to their employees for a proposed study, the IRB will want to clearly and completely understand what that entails. As an example, the IRB will think about the following types of questions when reading through a submission:

• How will you access participants? Who is connecting you with the people you want to interview, and what are the steps involved?
• Who is contacting or recruiting potential participants? Is a CEO, director, or HR sending a recruitment email or posting a flyer on your behalf? Are you receiving email addresses to contact participants directly? How will contact details move through the chain, and what measures are in place to minimize risks (such as privacy, anonymity, and so on)?
• If a company or organization facilitates access to participants, are they going to know who agrees to participate? Where will you interview those who want to participate? Are there ethical considerations you should address?
• Is this a business or organization where you work, and if so, what is your relationship to potential participants? How will you minimize risks of coercion or undue influence?

Tip: Try thinking through each step of your study and consider the ethics and human component of the research. What happens or needs to happen at each step before moving forward? If you plan to send an email solicitation to potential participants, think about the specifics of what that entails. How do you receive the email addresses? When sending an email, will you blind copy everyone? How should interested individuals contact you? When and how will you provide informed consent documents, and how will you collect signed consent documents? How will you protect participants' privacy? Always be mindful of the ways you will honor the promise you made to protect human participants involved in research activities.

Ensure there is consistency throughout your project documents. IRB analysts read through all materials submitted to the IRB and often find that research design details have been modified at some point between finishing the research proposal and completing the IRB application. It is important that this information is current and accurately reflects the proposed study procedures.

Ensure all applicable documents are included in your protocol submission, especially letters of support and conflict of interest disclosures.