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.