What are some of the things the IRB reviewers are looking for in my application?
Are the following addressed in the Application/Protocol?
- Exemption category information and justification
- Background, objectives, description of research, and role of subjects
- Number of subjects, records or specimens
- Subjects are over age 18 and under age 89
- Health information is not collected or health information is collected and a HIPAA De-Identification Certification form is attached
- Expected duration of study and subject participation
- Risks/benefits to the subject and to society
- Explanation of how risks have been minimized
- Procedures for protecting anonymity or confidentiality
- Data security
- Recruitment procedures
- Gender/racial group involvement
- Access to study population and authority to review records
- Description of how subjects will be informed (cover letter, recruitment statement)
- Consent/assent process and forms
- Experience and role of investigators
- Conflicts of Interest explained
- Accompanying materials provided (sample survey questions, data collection sheet)
- Do the benefits of the research outweigh the risks?
Are the following addressed in the RECRUITMENT STATEMENT/COVER LETTER/DEBRIEFING and/or CONSENT Documents?
- Investigator's names and ranks
- Explanation of purpose and justification of research
- Description of subject's participation and duration (tasks and time)
- Description of risks and minimization of risks
- Explanation of how confidentiality/anonymity is protected
- How will data be collected/recorded
- Description of benefits to subject/society
- Explanation of voluntary participation
- Statement naming investigator who will answer questions and phone number, IRB contact information
- Is the document clearly written and in lay language and formated for easy reading? (Translated for subjects who are non-English speakers? )