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REFERENCES

Beecher, H. K. (1966). Ethics and clinical research. The New England Journal of Medicine, 274,1354-1360.

Belle, S. H., Burgio, L., Burns, R., Coon, D., Czaja, S. J., Gallagher-Thompson, D., . . . Zhang, S. (2006). Enhancing the quality of life of dementia caregivers from different ethnic or racial groups. Annals of Internal Medicine, 145, P727-P738.

Black, B. S., Kass, N. E., Fogarty, L. A., & Rabins, P V (2007). Informed consent for dementia research: The study enrollment encounter. IRB: Ethics & Human Research, 29(4), 7-14.

Black, B. S., Rabins, P V, Sugarman, J., & Karlawish, J. H. (2010). Seeking assent and respecting dissent in dementia research. American Journal of Geriatric Psychiatry, 18(1), 77-85.

Czaja, S. J., Schulz, R., Belle, S. H., Burgio, L. D., Armstrong, N., Gitlin, L. N., . . . Stahl, S. M. (2006). Data safety monitoring in social behavioral intervention trials: The REACH II experience. Clinical Trials, 3, 107-118.

Horigian, V E., Robbins, M., Dominguez, R., Ucha, J., & Rosa, C. L. (2010). Principles for defining adverse events in behavioral intervention research: Lessons from a family- focused adolescent drug abuse trial. Clinical Trials, 7(1), 58-68.

National Institute on Aging. (2013). Adverse events (AEs) and serious adverse events (SAEs) guidelines. Retrieved July 1, 2015, from https://www.nia.nih.gov/research/dgcg/ clinical-research-study-investigators-toolbox/adverse-events

National Institute on Aging. (2015). Research & Funding. Division of Extramural Activities: Implementation of policies for human intervention studies. Retrieved June 30, 2015, from https://www.nia.nih.gov/research/dea/implementation-policies-human-intervention- studies#ReqDSMB

National Institutes of Health. (2010). Frequently asked questions from applicants: Human subjects research—Data and safety monitoring. Retrieved June 30, 2015, from http://grants .nih.gov/grants/policy/hs/faqs_aps_dsm.htm#186

O’Mathuna, D. P (2012). Ethical considerations in designing intervention studies. In B. M. Melnyk & D. Morrison-Beedy (Eds.), Intervention research: Design, conduction, analyzing and funding (pp. 7-79). New York, NY: Springer.

Resnik, D. B. (2011). What is ethics in research & why is it important? Retrieved July 1, 2015, from http://www.niehs.nih.gov/research/resources/bioethics/whatis/

Schulz, R., Czaja, S. J., Lustig, A., Zdaniuk, B., Martire, L. M., & Perdomo, D. (2009). Improving the quality of life of caregivers of persons with spinal cord injury: A randomized controlled trial. Rehabilitation Psychology, 54, 1-15.

Shamoo, A., & Resnik, D. (2009). Responsible conduct of research (2nd ed.). New York, NY: Oxford University Press.

U.S. Department of Health and Human Services. (1979). The Belmont Report. Retrieved July 1, 2015, from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

U.S. Department of Health and Human Services (2007). Guidance on reviewing and reporting unanticipated problems involving risks to subjects or others and adverse events. Retrieved July 14, 2015, http://www.hhs.gov/ohrp/policy/advevntguid.html U.S. Department of Health and Human Services. (2009). Code of federal regulations—Title 45, public welfare. Part 46: Protection of human subjects. Washington, DC: U.S. Government Printing Office.

 
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