TABLE 1—

Illustration of Balanced Practices and Attitudes Versus Status Quo: Vulnerable Research Participants Protection

Status Quo Practices and Attitudes	Balanced Practices and Attitudes	Benefits
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