Identifying possible depression in clinical research: Ethical and outcome considerations for the investigator/clinician☆☆☆
Article Outline
Abstract
Most nurse researchers are aware of the ethical implications of research including the need to ensure confidentiality for research participants, as well as to provide full disclosure of the risks and benefits of the study. However, another consideration that can impact methodology from the perspective of the protection of human subjects from research risks includes the measurement of certain psychosocial variables such as depression and appropriate disclosure of such information to research participants. This issue has received little attention in the nursing literature. The intent of this article is to provide an overview of (1) the importance of informing participants about possible depression, (2) issues of identifying potential depression in clinical research including those related to depression measures, (3) strategies for the investigator/clinician to ensure protection of research participants and potential impact of those strategies, and (4) considerations in addressing depression in study design and analysis. Copyright 2003, Elsevier Science (USA). All rights reserved.
No full text is available. To read the body of this article, please view the PDF online.
References
- . BDI-II manual. San Antonio, TX: The Psychological Corporation; 1996;
- . Family function, stroke recovery, & caregiver outcomes. (5R01NR07612, National Institute of Nursing Research). Consent form 2000;
- . Do depression symptoms predict early hypertension incidence in young adults in the CARDIA study? Coronary Artery Risk Development in Young Adults. Archives of Internal Medicine. 2000;160:1495–1500
- . What makes clinical research ethical?. Journal of the American Medical Association. 2000;283:2701–2711
- . Depression and health-care costs during the first year following myocardial infarction. Journal of Psychosomatic Research. 2000;48:471–478
- . Depression and 18-month prognosis after myocardial infarction. Circulation. 1995;91(4):999–1005
- . Poststroke depression: An examination of the literature. Archives of Physical Medicine & Rehabilitation. 1997;78:658–663
- . Ethics lapses at Duke halt dozens of human experiments. The New York Times. 1999, May 13;A26
- . The influence of anxiety and depression on outcomes of patients with coronary artery disease. Archives Internal Medicine. 2000;160:1913–1921
- . Are symptoms of anxiety and depression risk factors for hypertension? Longitudinal evidence from the National Health and Nutrition Examination Survey I Epidemiologic Follow-up study. Archives of Family Medicine. 1997;6:43–49
- . Mental health and general well-being. In: Guralnik JM, Fried LP, Simonsick EM, Kasper JD, Lafferty ME editor. The Women's Health and Aging Study: Health and Social Characteristics of Older Women with Disability. Bethesda, MD: National Institute on Aging; 1995;p. 85–95 NIH Pub. No. 95-4009
- . Depression and 1-year prognosis in unstable angina. Archives of Internal Medicine. 2000;160(9):1354–1360
- . Anxiety and depression: Incidence and patterns in patients after coronary artery bypass graft. Applied Nursing Research. 2001;14:155–164
- . Measuring health: A guide to rating scales and questionnaires. 2nd ed. New York: Oxford University Press; 1996;
- . A 40-year perspective on the prevalence of depression: The Stirling county study. Archives of General Psychiatry. 2000;57(3):209–215
- . The invisible disease: Depression. http://www.nimh.nih.gov/publicat/invisible.cfm2001; (NIH Publication No 01-4591). Available at Accessed October 16, 2001
- . Diagnosis and treatment of depression in cancer patients. Oncology. 1999;9:1293–1306
- . The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385–401
- . The ethical basis of psychiatric research: Conceptual issues and empirical findings. Comprehensive Psychiatry. 1998;39:99–110
- . Trends in causes of death among the elderly. Aging Trends, 1, Hyattsville, MD: National Center for Health Statistics. http://www.cdc.gov/nchs/data/agingtrends/01deaths.pdf2001; Available at Accessed June 30, 2001
- . Assessing depression in primary medical and psychiatric practices. Archives of General Psychiatrity. 1985;42:1164–1170
- . Psychiatric and physical morbidity effects of dementia caregiving: Prevalence, Correlates, and Causes. The Gerontologist. 1995;35:771–791
- . Effects of consent form information on self-disclosure. Ethics & Behavior. 1997;7(4):299–310
- . Effects of researcher follow-up of distressed subjects: Tradeoff between validity and ethical responsibility. Ethics & Behavior. 1991;1(2):105–112
- . Ethical responsibilities to depressed research participants. Professional Psychology: Research and Practice. 1988;19:279–285
- . A review of the relationship between depression and diabetes in adults: Is there a link?. Diabetes Care. 2000;23:1556–1562
- . Caregiving experiences after stroke. Nursing Research. 2001;50:53–60
- . Measurement in nursing research. Philadelphia, PA: F.A. Davis; 1991;
- . Depression, falls, and risk of fracture in older women. Archives of Internal Medicine. 1999;159:484–490
- . Does depression invalidate competence? Consultants' ethical, psychiatric, and legal considerations. Cambridge Quarterly of Healthcare Ethics. 1993;2(4):505–515
- . Screening for depression in primary care clinics: The CES-D and the BDI. Archives of General Psychiatry. 1990;42(12):1164–1170
☆ Supported in part by a grant from the National Institutes of Health, National Institute of Nursing Research (#5R01NR07612) and a grant-in-aid (#9950220N) American Heart Association.
☆☆ Address reprint requests to Patricia C. Clark, PhD, RN, 1520 Clifton Road, Emory University, Atlanta, GA 30322.
PII: S0897-1897(02)10906-2
doi:10.1053/apnr.2003.50003
© 2003 Published by Elsevier Inc.
