NIH
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
- Week 1: NIH Protecting Human Research Participants Reflection