Identify vulnerable populations and the special restrictions

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Assignment: NIH Protecting Human Research Participants Reflection

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 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.
Protecting Human Research Participants

NIH Office of Extramural Research

Introduction

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.

Who?

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.

What?

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.

Why?

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.

Task

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:

1. Describe the circumstances that influenced the need for a policy to protect human research subjects. Give examples of specific ways human research subjects can be harmed by researchers.

2. Identify three vulnerable populations and the special restrictions associated with human research among these groups. Evaluate the requirements and restrictions. Do you think they are adequate? Why or why not?

3. The Belmont Report summarizes the ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Even though these principles are considered equal, prioritize them in order of importance to you. Explain your decisions.

4. Although you are not implementing a change project at this time, and you may not be directly involved in research as part of your professional responsibilities, explain the reasons why it is important for you to know about these rights and protections.

Reference no: EM133511916

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