IRB Applications Ten Common Mistakes

1. Failing to attach documents properly

Note how the above attachment displays the entire document inside the form. This is the wrong way to attach a document. IMPROPER WAY TO ATTACH A DOCUMENT WRONG

Note how the above example only displays the icon inside the form. This is the right way to attach a document. PROPER WAY TO ATTACH A DOCUMENT RIGHT

Tip: Make sure to check the “display as icon” box when attaching a document.

Successful completion of both courses is required for all USM personnel participating as PIs or other investigators in human subjects research. In the case of undergraduate and graduate student researchers, certificates from committee or thesis chairs for both courses also need to be attached. 2. Failing to complete and/or attach both required CITI training course certificates

CITI CERTIFICATION CHECKLIST CITI Common (Basic) & Human Subjects Research Certificates for the Principal Investigator CITI Common & Human Subjects Research Certificates for all other investigators CITI Common & Human Subjects Research Certificates from graduate or thesis chairs (student researchers only)

3. Failing to have appropriate external agency permission documents attached

“Official” documents consist of documents on institutional letterhead or scanned copies of s from authorized individuals.

4. Researchers sending in applications directly, rather than having them sent in by department chair or unit head ResearcherChairIRB Note: Receiving IRB applications directly from the department chair or unit head is the IRB’s way of verifying that the relevant supervisor knows of the project and approves.

Student researchers should send completed applications to their designated research advisor. Student Research Researcher Advisor Depart. Chair IRB

5. Failing to explain research procedures and purpose of the research clearly and in sufficient detail

Tip: While IRB members are experienced researchers, you should not expect them to be experts on the fine points of your particular area of research. Your project needs to be explained clearly and completely enough such that someone unfamiliar with your area of work can understand exactly what you are proposing and why it matters. IRB review requires the assessment of risks to human subjects relative to research benefits. Thus, it is imperative that IRB members have a good grasp of the project.

Common description failures: Failures to explain how confidentiality will be maintained Failures to discuss steps for mitigating risks Failures to clearly state the purpose of the research

6. Failing to include all relevant information and attach relevant supplemental documents (survey instruments, consent forms, and recruitment materials)

Tip: Use the check boxes at the bottom of the form and go through them one by one as you attach documents.

7. Consent forms contain jargon or are written at too high a level.

TIP: When writing, consider your audience and their likely knowledge level of the subject matter. The consent form indicates information that will be received by research participants. In order for consent to be genuinely informed, participants must understand exactly what you’re telling them in terms of the nature of your project, their role in it, and possible risks and benefits of their participation.

8. Confusing anonymity with confidentiality

ANONYMOUS & CONFIDENTIAL “Anonymous” means the identity of participants is unknown and cannot be known even by the researcher. An online survey might be anonymous, but only if computer tracking information has been de- linked from participant responses. Studies involving personal interviews with participants are by their very nature not anonymous, because even if the subject’s identity is not revealed to others, the researcher still knows who the participants are. Research is confidential when the subjects’ identities will not be disclosed.

9. Typos and inconsistencies

It is not unreasonable to wonder about how conscientious or careful a researcher will be when dealing with human subjects if it appears that the researcher can’t be bothered to carefully proofread his or her application. Simple grammar and spelling mistakes, as well as glaring inconsistencies (e.g., between applications and consent forms) are distressingly common.

10. Failing to respond adequately to revisions requested by the reviewer If the reviewer requests that you fix x, y, z, and you do not do so, you should not expect the reviewer to approve of your revision.

Questions?

Contact the Institutional Review Board International Building Room 413 Phone: Dr. Sam Bruton, IRB Director JoAnn Johnson, IRB Manager Dan Childers, Research Assistant Presentation compiled by Dan Childers, September 2014