What are some red flag ethical issues that might need to be discussed with IRB Staff during prospectus development?

If a researcher is thinking about collecting data on any of the following sensitive topics or from any of the following vulnerable populations, it is advisable to take part in IRB Office Hours during the proposal writing process in order to obtain ethics guidance that can be incorporated into proposal drafts and research planning. It is also possible to email a specific question to [email protected].

 All researchers planning to collect data in their own workplace can benefit from a consultation at IRB office hours.

The dual roles will need to be managed and IRB can help the researcher explore possibilities early on. Many researchers are not aware of the option to perform a secondary analysis of data that were created as part of the site’s operations (or will be created as part of the site’s operations in the future). This approach can often streamline steps and give the researcher a broader dataset for analysis.

 Researchers studying the following sensitive topics would also benefit from early ethics consultation.

The following types of data can be collected but only within certain ethical parameters, which the IRB can discuss with the researcher during proposal development.

• Questions about professional work that might lead to disclosure of behavior(s) or views that could potentially get someone fired or passed over for promotion (e.g., cutting corners, lack of compliance with policy, disagreement with leadership decisions)
• Questions about substance use, mental state, or violence that might obligate a referral or intervention to prevent harm to the participant (addiction, severe depression, suicidality, eating disorders, bullying, physical threats)
• Illegal activities in which the participant might incriminate him/herself via research data (e.g. illegal drug use, illegal immigration, child neglect, insider trading, harassment, assault, bullying,  cyberbullying)
• Personal issues that could severely distress an individual if framed in a judgmental, non-inclusive, dismissive, or otherwise insensitive manner (ethnicity, body image, religion, etc.)
• Race or ethnicity as a variable or inclusion criterion
• Outcomes of a new intervention or program (that is not already part of standard offerings) in an education, psychological, or clinical setting (please refer to Research Ethics FAQs for Clinical/Intervention Research or Research Ethics FAQs for Educational Settings for additional information)

 Studies specifically recruiting the following vulnerable populations also benefit from early ethics consultation

• Minors (age 17 and under)
• Adult students of the researcher
• Subordinates of the researcher
• Patients of the researcher
• Nursing home residents
• Prisoners
• Mentally impaired or disabled individuals
• Emotionally-impaired or disabled individuals
• Physically impaired or disabled individuals
• Individuals who may be less than fluent in English (within US)
• Undocumented immigrants
• Victims/witnesses of violent crime or other trauma (example: natural disasters)
• Active duty military personnel (due to the additional protections and gatekeeper approvals required by the federal government)
• Any others who may be particularly unable to protect their own rights or interest