Protecting human research participants is of utmost importance. Even though your change project will not be implemented in the field, and you will not be engaging with human subjects in this context, it is still critical that all healthcare professionals have a solid foundation in patient rights and protections within the realm of research.
It is essential that all healthcare professionals, whether or not they are currently involved in research studies, remain aware of regulatory policies and updates such as the Federal Policy for the Protection of Human SubjectsLinks to an external site.
https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for- the-protection-of-human-subjects, or Common Rule, that will take effect January 2019.
Review the Frequently Asked Questions on Requirements for Education at the National Institutes of Health (NIH) link here: https://humansubjects.nih.gov/requirement- education Links to an external site.
Download the PDF documents listed below. Read the detailed document by the NIH and then take the self-check quiz to check your understanding before completing this week’s assignment.
Protecting Human Research Participants
NIH Office of Extramural Research
Research with human subjects can occasionally result in a dilemma for investigators. When the goals of the research are designed to make major contributions to a field, such as improving the understanding of a disease process or determining the efficacy of an intervention, investigators may perceive the outcomes of their studies to be more important than providing protections for individual participants in the research.
Although it is understandable to focus on goals, our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles.
This course is intended for use by individuals involved in the design and/or conduct of National Institutes of Health (NIH) funded human subjects research.
This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants.
As a part of NIH’s commitment to the protection of human subjects and its response to Federal mandates for increased emphasis on protection for human subjects in research, the NIH Office of Extramural Research released a policy on Required Education in the Protection of Human Research Participants in June 2000. This course is specifically designed for extramural investigators and is one (of many) possibilities for meeting the policy requirement.
Because this course is intended to allow investigators to fulfill the Required Education in the Protection of Human Research Subjects, it assumes that the investigators’ research will be funded by NIH and is therefore subject to all U.S. Department of Health and Human Services (HHS) regulatory and NIH policy requirements.
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This week, reflect on what you learned from the NIH materials about protecting the rights of human research participants.
Discuss at least two of the following in your paper:
Your reflective paper should be two pages and written in current APA Style. Refer to the rubric for more information.
NURS_691A_DE – NIH assignment rubric
Criteria | Ratings | Pts |
This criterion is linked to a Learning Outcome Content |
21 to >19.32 pts Accomplished The responses fully address all elements of at least two writing prompts. The responses provide detail and/or quality examples for each prompt. The responses present insightful, clear, and accurate connections to NIH policies, procedures, and history. The responses present personal reflection and/or a willingness to consider multiple possibilities. |
21 pts |
This criterion is linked to a Learning Outcome Organization and Writing |
10.5 to >9.66 pts Accomplished There is a well-written, clear introduction, body, and conclusion. The introduction provides an overview of the topic. The information in the body is relevant and presented in a logical order. The conclusion summarizes the topic and includes the writer’s thoughts on the subject. The writing is fluid and concise, and the word choice is excellent. |
10.5 pts |
This criterion is linked to a Learning Outcome Mechanics and APA Format |
3.5 to >3.22 pts Accomplished The answers are well written throughout. Information is well organized and clearly communicated. The assignment is mostly free of spelling and grammatical errors. Information from sources is paraphrased appropriately and accurately referenced and cited in APA Style when applicable. The paper meets assignment length requirements. |
3.5 pts |
Total Points: 35 |
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