Week 1: 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 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-

educationLinks 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

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.
Archived Content: Last maintained 9/26/2018

Assignment

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:

• 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.

• 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?

• 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.

• 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.

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

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