Table 1. Conventional distinctions between research with human participants and clinical care of patients.

Areas of contrast	Research	Clinical care and laboratory practice
Personnel	Investigator and participant	Clinician and patient
Goals	Seek generalizable knowledge	Advance patient well-being
Professionals’ core duty	Duty to conduct research in compliance with scientific and ethical standards	Duty of clinical care in keeping with standards of care
Key sources of standards	Common Rule, FDA regulations on human subjects research, Nuremberg Code, Declaration of Helsinki, CIOMS Guidelines, Good Clinical Practice	Established standards of care, clinical guidelines, clinical laboratory standards (e.g., CLIA, state law), malpractice adjudication
Primary mechanisms to enforce standards	Prior IRB review and ongoing oversight, research funder review and oversight, federal OHRP investigation, FDA oversight of drugs and devices	Licensure, discipline, and clinical privileges; Joint Commission accreditation; laboratory certification and inspection; malpractice adjudication
Funding	Research grants and contracts, industry funding of research	Payers including patients, insurers, state and federal programs
Records	Research records	Medical records

CIOMS, Council for International Organizations of Medical Sciences; CLIA, Clinical Laboratory Improvement Amendments; FDA, Food and Drug Administration; IRB, institutional review board; OHRP, Office for Human Research Protections.