title: Ethical considerations in research participation among acutely injured trauma survivors: an empirical investigation.
abstract: Posttraumatic behavioral and emotional disturbances occur frequently among physically injured trauma survivors. Despite increasing investigative interest in the evaluation and treatment of psychological distress in acutely injured patients, few studies have assessed ethical considerations surrounding research participation. The authors empirically investigated ethical considerations in research participation among 117 physically injured, hospitalized, motor vehicle accident and assault survivors. Immediately following a 1-hour research interview, participants responded to 10 questions assessing the experience of research participation. The majority of study subjects found participating in the protocol a positive experience. Most of the hospitalized patients reported that they experienced control over initiation and discontinuation of the protocol and that they derived benefit from their research participation. A minority of participants reported that they experienced unwanted thoughts and unanticipated upset during the protocol and that they felt they could not refuse participation. However, over 95% of patients reported that the benefits of protocol participation outweighed the costs and that in retrospect they would again agree to participate. These results suggest that while a minority of participants may have difficulties with specific aspects of protocol enrollment, overall research participation is well tolerated by the majority of acutely injured, hospitalized, trauma survivors.
authors.affiliation: National Center for PTSD, Education Division, VA Palo Alto Health Care System, Palo Alto, CA, USA.
authors.forename: J I
authors.initials: JI
authors.lastname: Ruzek
authors.forename: D F
authors.initials: DF
authors.lastname: Zatzick
mesh_terms: D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000523:psychology; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007406:Interview, Psychological; D008297:Male; D008875:Middle Aged; D009104:Multiple Trauma / Q000523:psychology*; D010342:Patient Acceptance of Health Care / Q000523:psychology*; D010552:Personality Assessment; D013313:Stress Disorders, Post-Traumatic / Q000523:psychology / Q000628:therapy*; D017741:Survivors / Q000523:psychology*