Family and physician influence on asthma research participation decisions for adolescents: the effects of adolescent gender and research risk.
OBJECTIVE
There is considerable ethical and legal ambiguity surrounding the role of adolescents in the decision-making process for research participation. Depending on the nature of the study and the regulations involved, adolescents may have independent responsibility for providing informed consent, they may be asked to provide their assent, or they may be completely excluded from the decision-making process. This study examined parent and adolescent perceptions of decision-making authority and sources of influence on adolescent research participation decisions, and examined whether perceptions of influence differed based on adolescent gender and level of research risk.


METHODS
Adolescents (n = 36) with asthma and their parents reviewed 9 pediatric research protocols, decided whether they would choose to participate, rated the extent they would be responsible for the actual decision, and indicated the ability of family and physician to influence their decisions. Multivariate analyses of variance were used to evaluate differences in perceptions of decision-making authority and sources of influence on the decisions.


RESULTS
Adolescents were less willing to cede decision making authority to parents than parents anticipated. Parents and adolescents acknowledged a greater openness to influence from physicians than from family for above minimal risk studies. Parents were more willing to consider opinions from male adolescents.


CONCLUSIONS
Adolescents desire responsibility for research participation decisions, though parents may not share these views. Physicians' views on research participation are important to families, especially for above minimal risk studies. Parents may grant more decision-making autonomy to adolescent males than to females. Researchers, physicians, and institutions play a key role in facilitating the ethical enrollment of adolescents into biomedical research. Educational, policy, and oversight processes that support both adolescent autonomy and parental responsibility for research participation decision-making in biomedical research are discussed.
Brody
Janet L
JL
Center for Family and Adolescent Research, Oregon Research Institute, 2700 Yale SE, Suite 200, Albuquerque, New Mexico 87106, USA. jbrody@ori.org
Scherer
David G
DG
Annett
Robert D
RD
Turner
Charles
C
Dalen
Jeanne
J
D000293:Adolescent; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D001249:Asthma / Q000097:blood / Q000523:psychology* / Q000628:therapy; D001291:Attitude of Health Personnel; D001774:Blood Chemical Analysis / Q000523:psychology; D002648:Child; D002985:Clinical Protocols; D003657:Decision Making; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007258:Informed Consent; D007858:Learning / Q000187:drug effects; D008297:Male; D009569:Nitric Oxide / Q000097:blood; D010287:Parent-Child Relations; D010290:Parents; D010342:Patient Acceptance of Health Care / Q000523:psychology*; D010353:Patient Education as Topic; D010358:Patient Participation / Q000523:psychology*; D026684:Personal Autonomy; D010820:Physicians; D011287:Prejudice; D000297:Psychology, Adolescent; D045808:Refusal to Participate / Q000523:psychology; D012106:Research; D012108:Research Personnel; D035842:Research Subjects / Q000523:psychology*; D012306:Risk; D012737:Sex Factors; D020458:Third-Party Consent
D018927:Anti-Asthmatic Agents; D009569:Nitric Oxide; D006854:Hydrocortisone