Suggestions from the IRB

To improve the review…..

The protocol, consent documents and submission forms are a reflection of you to the IRB. A well-prepared submission reflects a conscientious and ethical investigator and research team.

Take time to think!

• Submit your materials early.
• Submissions received after the deadline will be reviewed at the next scheduled meeting.

Ask for help.

Ensure that all Pre-IRB requirements are completed:

• Applicable Clinical Research Review Committee approval
• HSP mandated education and training
• Departmental reviews and signatures
• Sponsor or funding agency approval

Assess the protocol.

• Does the design have scientific merit?
• Make sure that the research procedures have safeguards in place to minimize exposure to research risks.
• Describe the recruitment and informed consent procedures carefully and clearly.

Assess the informed consent/parental permission and assent forms.

• Use only the most current informed consent/parental permission and assent template.
• Be honest and straightforward about the risks, benefits and scientific importance of your study and communicate all of these clearly
• Do not look at the template as a final product. The IRB cannot make a template for every possible consent document. YOU are the only one who knows the proposal in detail.
• Ask the following questions: 
  • How many consent do I need? Some studies involve more than one population (comparator group, family member etc)
  • What is the age range? Nemours requires the assent process to be developmentally adjusted. We require a 7-11 and a 12 to 17
• Read the form from a parents perspective.
• Have someone outside of your research group, or someone other than the author, critique the consent and assent forms before submission.
• Explain any deletions and changes to the template.

Ensure accuracy and completeness of the submission forms.

• Proof read.
• Read through the materials you are submitting to ensure that there are no inconsistencies or contradictions
• Include copies of advertisements, flyers, recruitment letters, etc.