Improving Effectiveness of Informed Consent Process

Informed consent has been preserved as a sacred value since medicine started caring for the sick and it is still upheld today as a critical component of clinical research. Ensuring voluntary participation through an informed decision-making process in clinical research continues to be an ethical and moral obligation of the study team, quite often the study nurses. Over time these forms have reached a degree of unreasonableness; exceeding twenty pages, being too complex, and readability that exceeds the targeted populations. A deluge of literature over the past decade reaffirms and begs for change. In 2011, the federal government agency, Office of Human Research Protections, has responded by publishing and receiving comments on an Advanced Notice of Proposed Rule-Making (ANPRM); however, there has been no further public information of action. This brief aims to provide an overview of the issues, background, as well as several possible ways to lobby for action.

Transforming the Informed Consent Forms:

Improving Effectiveness of Informed Consent Process

A growing subspecialty of nursing practice is clinical research nursing. According to Harvard’s Catalyst Clinical Research Center (HCCRC) and the National Institutes of Health (NIH) nurses play an active role in providing care within a delivery system that is focused on conducting clinical research (HCCRC, 2014). Nurses serve as clinical research nurses and as study nurse coordinators. Within these roles they have the added responsibility of ensuring care is delivered in compliance with the protocol, as well as human subjects protections’ ethical and regulatory guidelines, policies, and regulations that span from an institutional level, to the state level and up to the f...

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...n your organization. Retrieved on Febuary, 10th, 2014, retrieved from http://www.simply-communicate.com/news/top-tips/internal-communication/creating-change-champions-your-organization .

Menikoff, personal communication, November 21, 2012.

U.S. Department of Health & Human Services. (2011.). ANPRM for revisions to the common rule. Office of Human Research Protections: Washington D.C. Retrieved on February 8th, 2014, from http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.

U.S. Department of Health & Human Services (1979). The Belmont report. Office of Human Research Protections: Washington D.C. Retrieved on Febuary 8th, 2014, from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.

Young, D. R., Hooker, D. T., & Freeberg, F. E. (1990). Informed consent documents:

increashing comprehension by reducing reading level. IRB, 12(3), 1-5.