Ethics of research for patients in pain.
OBJECTIVE
This review describes advances in rising and continuing ethical issues in research in patients in pain. Although some of the issues focus directly on pain research, such as research in neonatal pain management, others focus on widespread ethical issues that are relevant to pain research, such as scientific misconduct, deception, placebo use and genomics.


RESULTS
Scientific misconduct is more widespread than realized and requires greater awareness of the markers of misconduct like irreproducibility. More education about what qualifies as misconduct, such as consent violations, plagiarism and inappropriate patient recruitment along with data falsification needs to be implemented. Wayward researchers may attend a rehabilitation conference to improve their practices. Studies in neonatal pain management do not require comparing an intervention with the inadequate analgesia of a placebo; comparing with a standard approach is sufficient. Deception of research patients may be acceptable under narrow circumstances. The legitimacy of using broad informed consent for biobanking and genomic studies are being challenged as changes to the Common Rule are being considered.


CONCLUSIONS
Increasing complexity and the desire to further medical knowledge complicates research methods and informed consent. The ethical issues surrounding these and offshoot areas will continue to develop.
Harvard Medical School, Boston Children's Hospital, Boston, Massachusetts, United States.
David B
DB
Waisel
D018070:Biological Specimen Banks / Q000941:ethics; D035843:Biomedical Research / Q000941:ethics* / Q000379:methods; D008192:Deception; D023281:Genomics / Q000941:ethics; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent / Q000941:ethics*; D059408:Pain Management / Q000941:ethics* / Q000379:methods; D018579:Patient Selection / Q000941:ethics*; D010919:Placebos; D015714:Plagiarism; D015871:Scientific Misconduct / Q000941:ethics*
D010919:Placebos