The IRB needs enough information about a research proposal to answer the following questions:
- Are the involved risks necessary and reduced as much as possible?
- Do the risks seem reasonable in relation to any anticipated benefits?
- Are the subjects selected/recruited equitably?
- Are subjects fully informed and freely consenting to take part?
- Does the project require waivers of any of the standard written consent elements?
- Are there adequate plans for safety monitoring?
- Is the privacy and confidentiality of subjects handled adequately?
- Are any especially vulnerable subjects given the necessary extra protection?
To help with this, the eIRB system asks a lot of questions about a proposed project. For a downloadable, step-by-step walkthrough/explanation of the main questions, see the HRPP Cayuse Walkthrough.
The questions vary according to the type of research being done, but generally speaking you should be prepared to provide the following information. A good rule of thumb before you begin is to figure out enough of the practical details that, should you receive approval, you could start your project immediately.
Personnel:
- A list of all research team members.
- Details concerning any non-MTU members.
- Statements about any conflicts of interest.
- Proof of each team member's ethics training (visitHuman Subjects Research (HSR) Training Requirements for the required CITI courses).
Basic Information:
- Details of any project funding.
- Information on generally where and when the research will take place.
- Details of any necessary arrangements with outside organizations.
Rationale:
- A statement of the overall aim of the project, and the research questions involved.
- A brief review of past scholarly work that justifies the project.
Recruitment:
- A description of the kinds of people to be involved as human subjects (including age ranges and any special inclusion/exclusion criteria).
- Details concerning where, when, and how these people will be found, selected, and recruited (including the wording of any recruiting "scripts" to be used: visit Recruting Subjects for instructions).
Procedures:
- Details of what the people will have to do, as well as where and when this will happen, and how long it will take (including any "instruments" involved, e.g. questionnaires, instructions, and interview protocols).
- Description of the kinds of information, data, and/or specimens that will be collected.
- Safety information about any drugs or medical devices involved.
- Details of any incentives to be used, as well as any deception (including how any deceived subjects will be debriefed afterwards).
Data Handling:
- Description of how the results of the research will be handled and stored.
- Description of how they will be analyzed.
- Details concerning any storage or archiving of data for use in future projects.
Risks and Benefits:
- Description of any benefits to the subjects involved (often there are no direct benefits).
- Listing of any potential physical, psychological, or social/legal risks involved (not just during the research itself, but also during recruitment, and after the research is complete. The latter often concern confidentiality).
Safety Procedures:
- Details of any safety monitoring procedures.
- Details of any resources and procedures should anything go wrong.
- Description of how communications and data handling/storage will prevent breaches of confidentiality (if that is an issue).
- Description of how reporting of the results will be done in a way that maintains confidentiality (if that is an issue).
Informed Consent Procedures:
- Description of how and when subjects will have the project described to them, and be allowed to freely decide if they want to take part.
- Justification of any departures of these procedures from normal MTU HRPP standards (visit Waiving Consent or Documentation of Consent for types of "waiver").
- Details of the verbal scripts or written forms involved (visit Obtaining Consent for an explanation).
If you can provide all these things, you should be in good shape to submit a proposal through the eIRB system. Again, the HRPP Cayuse Walkthrough provides a step-by-step guide to the main question boxes.
If at any point you are unsure of what information to provide, feel free to contact HRPP staff at irb@mtu.edu or (906) 487-1799. You will generally be all right if you fill things in according to your best understanding, because all submissions are "pre-reviewed" by HRPP staff anyway, to make sure they are complete and detailed enough. The staff will contact you to discuss how to resolve any ambiguities or omissions, and once this is done the submission will be assigned to one of three review procedures: Exempt, Expedited, or Full Board. Visit Review Proceduresfor an explanation of what these entail.