Begin with consideration of special populations |
Begin with consideration of risk level posed by study design |
Avoid unnecessary burdens on valuable research |
More protections are better; play it safe |
As many protections as necessary, as few as possible; too many protections cause harm |
Avoid harm owing to overprotection |
Safeguards based on hunches or stereotypes |
Safeguards based on best available evidence and dialogue with relevant communities |
Avoid unfair stereotyping |
Institutional review boards, researchers, and ethicists are the best people to determine which protections are needed |
Participant communities have unique expertise on many issues of ethics: benefits, risks, privacy, autonomy, etc. |
Provide a voice to those most affected by the research |
Focus on decisional capacity of participants |
Focus on the subjective outcomes of the consent process |
Address system problems while avoiding a focus on individual deficits |
Special safeguards required only for vulnerable groups |
Universally apply safeguards when needed |
Avoid stigmatization while protecting all groups when justified by risk level |