Description
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., 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 Download Protecting Human Research Participants
Self-check QuizDownload Self-check Quiz
If you would like to review more information, you can go to the following link to view 12 recorded webinars related to Human Research Protection on the U.S. Department of Health and Human Services YouTube channel: https://www.youtube.com/watch?v=9r8cpgWs7j4&list=PL5965CB14C2506914Links to an external site.
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.
Due: Sunday, 11:59 p.m. (Pacific time)
Points: 35
Rubric
NURS_691A_DE – NIH assignment rubric
NURS_691A_DE – NIH assignment rubric
Criteria Ratings Pts
This criterion is linked to a Learning OutcomeContent
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.
19.32 to >17.22 pts
Satisfactory
The responses address all elements of at least two writing prompts, but may be vague or incomplete in some places. Some details or examples may not support the prompt(s) very well. The responses present accurate connections to NIH policies, procedures, and history. The responses present personal reflection and/or a willingness to consider multiple possibilities, but explanations may be vague or incomplete in some places.
17.22 to >12.6 pts
Needs Improvement
One or more responses do not address all elements of at least two prompts. Details and examples may be missing, or are unclear. One or more responses do not present accurate connections to NIH policies, procedures, and history. One or more responses do not present personal reflection and/or a willingness to consider multiple possibilities.
12.6 to >0 pts
Unsatisfactory
The responses are inaccurate or unrelated to the prompts and/or several components of the prompts are not addressed. There are no details or examples.
21 pts
This criterion is linked to a Learning OutcomeOrganization 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.
9.66 to >8.61 pts
Satisfactory
The introduction provides a general overview of the topic, but may be incomplete. The information in the body is mostly relevant and mostly presented in a logical order. The conclusion summarizes the topic, but may be brief, incomplete, or abrupt. The writing is clear, and the Word choice is satisfactory.
8.61 to >7.24 pts
Needs Improvement
The introduction, body, and conclusion are not clear and distinct. The information in the body is not relevant, or is off topic. The information is not presented in a logical order. The conclusion is incomplete, off-topic, or missing.
7.24 to >0 pts
Unsatisfactory
There is no introduction, body, or conclusion. The assignment does not follow the required format.
10.5 pts
This criterion is linked to a Learning OutcomeMechanics 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.
3.22 to >2.87 pts
Satisfactory
Most answers are well written throughout. Information is well organized and clearly communicated. The assignment has a few spelling and grammatical errors. Most information from sources is paraphrased, referenced, and cited correctly in APA Style. The paper meets assignment length requirements.
2.87 to >2.42 pts
Needs Improvement
Some answers are poorly written or lack clarity and/or organization. There are multiple spelling and grammatical errors. Information from sources is missing or improperly cited. The paper does not meet assignment length requirements.
2.42 to >0 pts
Unsatisfactory
Answers are not well written and lack clarity. Information is poorly organized. The assignment contains many spelling and grammatical errors. No attempt to follow the required format is indicated. The paper does not meet assignment length requirements.
3.5 pts
Total Points: 35
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Protecting Human Research Participants:
Select Quiz Questions
Codes and Regulations: Section Quiz
1. Identify the most influential event that led to the HHS Policy for Protection of Human
Research Subjects:
A.
B.
C.
D.
Nuremberg trials
Syphilis Study at Tuskegee
Jewish Chronic Disease Hospital Study
Willowbrook Study
2. An institutionally designated authority, other than the investigator, should determine
that proposed studies are exempt from regulatory requirements.
A. True
B. False
3. The Belmont Report is significant because:
A.
B.
C.
D.
It was written by the National Commission for the Protection of Human Subjects.
It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.
Belmont is another word for individual autonomy and respect.
It was a seminal document about the concept of informed consent.
4. 45 CFR 46 requires Federal Departments and Agencies to rely solely on IRBs to
evaluate risks to subjects, protection against these risks, potential benefits of the
research and the importance of the knowledge to be gained.
A. True
B. False
5. A “systematic investigation designed to develop or contribute to generalizable
knowledge” may include:
A.
B.
C.
D.
Evaluation
Research Development
Testing
All of the above
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6. An “autonomous person” is someone who:
A. Has reached the legal age to provide informed consent in the State.
B. Is willing to accept certain risks if the research will benefit others in the future.
C. Understands the risks and benefits of his or her participation and is able to make a voluntary
decision if adequate information is provided.
D. Meets all eligibility criteria for a study and asks the investigator if she or he may participate.
Respect for Persons: Section Quiz
7. Why might an individual have diminished autonomy?
A.
B.
C.
D.
They are a neonate.
They are incarcerated or involuntarily confined.
They are unconscious.
All of the above.
8. In order to participate in research, children must:
A. Provide written informed consent
B. Provide written permission
C. Provide assent, unless the IRB determines that they are too young
9. For research involving pregnant women, participation requires:
A.
B.
C.
D.
That women have completed the first trimester.
That the study be conducted first in men.
Permission of the father.
Consideration of risks and potential benefits for the fetus and the pregnant woman.
10. The three fundamental principles of Informed consent are:
A.
B.
C.
D.
Voluntariness, Equipoise, Respect
Voluntariness, Comprehension, Disclosure
Benefits, Comprehension, Privacy
Disclosure, Equipoise, Privacy
11. The regulations strongly suggest but do not require that the informed consent
process be delivered in a language that is understandable to the subject.
A. True
B. False
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12. If informed consent information is presented orally, it must be documented using a
short form that states that all the required elements were presented orally.
A. True
B. False
Beneficence: Section Quiz
13. What is an appropriate method for maintaining confidentiality of private information
obtained from human subjects?
A.
B.
C.
D.
Keeping data in a password-protected database
Storing images in a secured cabinet
Coding data or specimens and keeping the key to the code in a separate, locked drawer
All of the above are ways to maintain confidentiality
14. If a researcher determines that his/her study poses no more than minimal risk as
defined in 45 CFR 46, there is no need for the protocol to have IRB review and
approval.
A. True
B. False
15. Which of the following most accurately describes clinical equipoise?
A. Scientific uncertainty that one study intervention is superior to another
B. A reasonable balance of risks and benefits to research subjects
C. When the probability and magnitude of harm or discomfort is not greater than those ordinarily
encountered in daily life or during the performance of routine physical or psychological exams
D. A double blind controlled trial
16. Because the expedited IRB review process is generally used for certain types of
minimal risk research, it is less stringent than review by the full IRB.
A. True
B. False
17. Therapeutic misconception is the tendency for investigators to mislead research
participants about the research purpose, procedures or benefits.
A. True
B. False
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Justice: Section Quiz
18. In localities where community consent is the norm,
A. A family member’s consent for another individual may be sufficient, as long as community
consent is given
B. Federal regulations preclude the conduct of PHS-funded research
C. Community consent to participate in the research study is sufficient and no IRB approval is
required
D. In addition to the cultural norm, individual informed consent is required
19. NIH has specific policies addressing:
A. Inclusion of children in research
B. Inclusion of women and minorities in research
C. Treatment for research subjects in HIV/AIDS antiretroviral studies following completing of trials
in developing countries
D. All of the above
20. IRBs reviewing research in a different geographical location and/or cultural context
have a responsibility to:
A. Obtain knowledge of the local context by talking to those who have traveled to the region
B. Defer to an IRB that is in the situated within the local research context
C. Ask specialists with direct knowledge of the local research context to participate in IRB
discussions
D. B or C
E. A or C
21. It is ethical to use deceptive methods in research when the scientific goals of the
project can be achieved by non-deceptive methods.
A. True
B. False
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Answer Key
Codes and Regulations
1.
2.
3.
4.
5.
6.
b) Syphilis Study at Tuskegee
a) True
b) It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations
b) False
d) All of the above
c) Understands the risks and benefits of his or her participation and is able to make a voluntary
decision if adequate information is provided
Respect for Persons
7. d) All of the above
8. c) Provide assent, unless the IRB determines that they are too young
9. d) Consideration of risks and potential benefits for the fetus and the pregnant woman
10. b) Voluntariness, Comprehension, Disclosure
11. b) False
12. a) True
Beneficence
13. d) All of the above are ways to maintain confidentiality
14. b) False
15. a) Scientific uncertainty that one study intervention is superior to another
16. b) False
17. b) False
Justice
18. d) In addition to the cultural norm, individual informed consent is required
19. d) All of the above
20. d) B or C
21. b) False
5
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.
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The information presented is neither prescriptive nor exhaustive and does not replace or
supersede local, state, or Federal regulations applicable to human research or any institutional
policies regarding the protection of human subjects.
Course Objectives
Upon completion of this course, you should be able to:
•
•
•
•
•
•
•
•
•
Describe the history and importance of human subjects protections
Identify research activities that involve human subjects
Discover the risks a research project might pose to participants
Understand how to minimize the risks posed by a research project
Describe additional protections needed for vulnerable populations
Understand additional issues that should be considered for international research
Describe appropriate procedures for recruiting research participants and obtaining
informed consent
Identify the different committees that monitor human subjects protections
Understand the importance of study design in the protection of research participants
The first module examines significant historical events that have contributed to the way we
view the protections for participants in clinical research today.
History
What This Module Covers:
Before discussing the current system for the protection of human subjects in research, it is
important to review some of the significant historical events that have influenced current
ethical guidelines and HHS regulations.
This module covers the following topics:
•
•
•
•
Goals and Principles of Human Subjects Protection
Nazi Medical War Crimes
Syphilis Study at Tuskegee
Timeline of Important Historical Events
Goals and Principles of Human Subjects Protection
Human subjects are essential to the conduct of research intended to improve human health. As
such, the relationship between investigators and human subjects is critical and should be based
on honesty, trust, respect.
Historical Events
Nazi Medical War Crimes (1939-1945)
Although not the first example of harmful research on unwilling human subjects, the
experiments conducted by Nazi physicians during World War II were unprecedented in their
scope and the degree of harm and suffering to which human beings were subjected.
“Medical experiments” were performed on thousands of concentration camp prisoners and
included deadly studies and tortures such as injecting people with gasoline and live viruses,
immersing people in ice water, and forcing people to ingest poisons.
In December 1946, the War Crimes Tribunal at Nuremberg indicted 20 physicians and 3
administrators for their willing participation in the systematic torture, mutilation, and killing of
prisoners in experiments. The Nuremberg Military Tribunals found that the defendants had:
•
•
Corrupted the ethics of the medical and scientific professions
Repeatedly and deliberately violated the rights of the subjects
The actions of these defendants were condemned as crimes against humanity. Sixteen of the
twenty-three physicians/administrators were found guilty and imprisoned, and seven were
sentenced to death.
Historical Events
The Nuremburg Code
In the August 1947 verdict, the judges included a section called Permissible Medical
Experiments. This section became known as the Nuremberg Code and was the first
international code of research ethics.
This set of directives established the basic principles that must be observed in order to satisfy
moral, ethical, and legal concepts in the conduct of human subject research. The Code has been
the model for many professional and governmental codes since the 1950s and has, in effect,
served as the first international standard for the conduct of research.
The Code Provides Ten Directives for Human Experimentation
Historical Events
The Syphilis Study at Tuskegee
Arguably the most notorious example in the United States of the violation of the rights and
welfare of human subjects was the long-term study of black males conducted by the United
States Public Health Service in Tuskegee, Alabama. This study of the natural history of
untreated syphilis was initiated in the 1930s and continued until 1972.
The Syphilis Study at Tuskegee involved approximately 600 African-American men: about 400
with syphilis (cases) and about 200 without syphilis (controls). These men were recruited
without informed consent and, in fact, were led to believe that some of the procedures done in
the interest of research (e.g., spinal taps) were actually “special free treatment.”
By 1936, it was apparent that many more infected men than controls had developed
complications, and 10 years later, reports indicated that the death rate among those with
syphilis was about twice as high as it was among the controls. In the 1940s, penicillin was found
to be effective in the treatment of syphilis. The Syphilis Study at Tuskegee continued, however,
and the men were neither informed about nor treated with the antibiotic.
Historical Events
Outcomes of the Syphilis Study at Tuskegee
The first accounts of this study appeared in the national press in 1972. The resulting public
outrage led to the appointment of an ad hoc advisory panel by the Department of Health,
Education and Welfare (which later was split into the Department of Education and the
Department of Health and Human Services [HHS]) to review the study and develop
recommendations to ensure that such experiments would never again be conducted.
Outcomes included:
1. National Research Act of 1974
2. Basic HHS Policy for Protection of Human Research Subjects
3. National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research
Timeline of Events
Click on the desired date or event to read more about that historical moment in the modern
history of human experimentation.
1932-1972: Syphilis Study at Tuskegee
More information may be found in:
Brandt, AM. 1978. Racism and Research: The Case of the Tuskegee Syphilis Study. Hastings
Center Report 8(6): 21-29, and in
Jones, JH. 1993. Bad Blood: Tuskegee Syphilis Experiment. Rev. ed. New York: Free Press
1939-1945: Nazi Medical War Crimes
More information may be found in: Annas, GJ, and Grodin, MA. 1992. The Nazi Doctors and the
Nuremburg Code, Human Rights in Human Experimentation. New York: Oxford University Press.
1944-1974: Cold War Human Radiation Experiments
The U.S. Government conducted more than 400 experiments to determine the effects of
exposure to ionizing radiation on human health or to calibrate instruments designed to detect
radiation. Most studies involved minimal risks and most of those involving greater than minimal
risks included appropriate informed consent.
There were, however, cases where human subjects suffered physical injuries as a result of
participating in studies that offered no prospect of direct benefit, or from interventions that
were considered controversial at the time that were presented as standard practice.
See https://www.atomicheritage.org/history/human-radiation-experiments for more
information.
1946: Nuremberg Doctors’ Trial
The individuals who conducted Nazi experiments during WWII were tried separately from other
war criminals because of their professional status as physicians and the horrendous and unique
nature of their crimes. They were found guilty of “crimes against humanity.”
See https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-formedical-research-involving-human-subjects/ for more information.
1947: Nuremberg Code & APA
Nuremberg Code
During the trial at Nuremberg, the judges codified fundamental ethical principles for the
conduct of research. The Nuremberg Code set forth ten conditions to be met before research
could be deemed ethically permissible. The Nuremberg Code became the first international
standard for the conduct of research and introduced the modern era of protection for human
research subjects.
American Psychological Association
The American Psychological Association began to develop a code of Ethical Standards that
included issues in human subjects research.
See http://www.apa.org/ethics/index.aspx for more information.
1948: United Nations adopted Universal Declaration of Human Rights
The United Nations adopted The Universal Declaration of Human Rights, which was inspired by
atrocities committed during World War II and states the conviction that human rights needed
to be preserved at the international level.
See http://www.un.org/Overview/rights.html for more information.
1953: First U.S. Federal Policy for Protection of Human Subjects
The first U.S. Federal policy for the protection of human subjects was put into place for
research conducted at the Clinical Center, NIH. This policy provided a mechanism for
prospective review of proposed research by individuals having no direct involvement or
intellectual investment in the research. This system is the model for the current IRB system.
1963: Jewish Chronic Disease Hospital Study
Studies were undertaken at the Jewish Chronic Disease Hospital in New York to develop
information about the human immune system’s response to cancer. Live cancer cells were
injected into chronically ill and debilitated patients who were told they were receiving a skin
test. The investigators were eventually prosecuted and found guilty of fraud, deceit, and
unprofessional conduct.
1963-1966: Willowbrook Study
Studies were carried out at the Willowbrook State School for “mentally defective persons,” to
gain an understanding of the transmission of infectious hepatitis and, subsequently, to test the
effects of gamma globulin in preventing or ameliorating the disease.
Residents of Willowbrook, all of whom were children, were deliberately infected with hepatitis,
by ingesting the stools of infected persons or receiving injections of more-purified virus
preparations. The investigators maintained that hepatitis infection was inevitable for this
population; however, critics asserted that the consent process was unethical because coercive
tactics were employed as only children whose parents gave permission to participate in the
studies were admitted to Willowbrook.
1964: Declaration of Helsinki
The World Medical Association drafted the first international agreement recommending ethical
standards for clinical research.
The most recent version of the Declaration of Helsinki, in addition to translations of the
Declaration into languages other than English, can be found on the WMA Web site.
Like the Nuremberg Code, the Declaration makes informed consent a central requirement for
ethical research. The Declaration does, however, allow for surrogate consent when the
research subject is incompetent, physically or mentally incapable of giving consent, or a minor.
The Declaration, which has undergone multiple revisions, also states that research with these
groups should be conducted only when the research is necessary to promote the health of the
population represented and when this research cannot be performed on legally competent
persons.
1966: Henry Beecher’s Publication
Henry Beecher published an article in the New England Journal of Medicine describing 22 cases
of human subjects research that involved ethical violations. Beecher argued against increasing
regulations and in favor of responsible investigators. His perspective has been cited as
influencing Federal policy to outline general requirements for informed consent and to
delegate specific standards to local review processes.
1974: Federal Protections for Human Subject
After the Syphilis Study at Tuskegee was exposed, the Senate Committee on Labor and Human
Resources held hearings on this study and other alleged health care abuses. The outcomes of
these hearings were:
The enactment of the National Research Act of 1974 requiring the Department of Health,
Education, and Welfare to codify its policy for the protection of human subjects into
regulations; and
The formation of the National Commission for the Protections of Human Subjects of Biomedical
and Behavioral Research, which drafted the Belmont Report.
1979: The Belmont Report
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research issued Ethical Principles and Guidelines for the Protection of Human Subjects of
Research. This is the cornerstone document of ethical principles and HHS regulations for the
protection of research subjects based on respect for persons, beneficence, and justice.
See http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html for more information.
1980: Publication of the FDA Regulations
FDA established regulations for clinical research: Code of Federal Regulations, Title 21, Part 50.
The FDA regulates research involving products regulated by the FDA, including research and
marketing permits for drugs, biological products, and medical devices for human use, etc.,
whether or not HHS funds are used. If HHS funds are used in FDA-regulated research, the
research must be compliant with both HHS and FDA regulations. More information about the
FDA regulations and FDA-specific requirements can be found at http://www.fda.gov/.
1981: HHS & FDA Revise Regulations
In 1981, with the Belmont Report as foundational background, HHS and the Food and Drug
Administration revised, and made as compatible as possible under their respective statutory
authorities, their existing human subjects regulations.
1982: CIOMS Guidelines
The Council for the International Organization of Medical Sciences (CIOMS) published the
International Ethics Guidelines for Biomedical Research Involving Human Subjects (CIOMS
Guidelines). These guidelines are designed to assist investigators from technologically advanced
countries to conduct ethical research involving human subjects in resource-poor countries.
These 15 guidelines addressed issues including informed consent, standards for external
review, recruitment of subjects, and more. For further information about CIOMS and the
Guidelines, refer to http://www.cioms.ch/
1991: Publication of the Common Rule
The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published
in 1991 and codified in separate regulations by 15 Federal departments and agencies
See: http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html for more information.
1993-1994: Revelation of Human Radiation Experiments
President Clinton established the Advisory Committee on Human Radiation Experiments to
investigate human radiation experiments during the period 1944 to 1974; examine cases in
which radiation was intentionally released into the environment for research purposes; identify
ethical and scientific standards for evaluating these events; and deliver recommendations to
the Human Radiation Interagency Working Group. The Committee recommended government
apologies and financial compensation in cases where:
Efforts were made by the government to keep information secret from these individuals, their
families or the public to avoid embarrassment or potential legal liability, and where this secrecy
had the effect of denying individuals the opportunity to pursue potential grievances
There was no prospect of direct medical benefit to the subjects, or interventions considered
controversial at the time were presented as standard practice, and physical injury attributable
to the experiment resulted
See https://ehss.energy.gov/ohre/roadmap/index.html for more information
1995: Establishment of The National Bioethics Advisory Commission
The National Bioethics Advisory Commission (NBAC) was established to promote the protection
of the rights and welfare of human subjects in research, identify bioethical issues arising from
research on human biology and behavior, and make recommendations to governmental
entities regarding their application. The NBAC term ended in 2001.
1996: Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
In response to a congressional mandate in the Health Insurance Portability and Accountability
Act of 1996 (HIPAA), the U.S. Department of Health and Human Services (HHS) issued the
regulations Standards for Privacy of Individually Identifiable Health Information. For most
covered entities, compliance with these regulations, known as the “Privacy Rule”, was required
as of April 14, 2003.
The Privacy Rule was enacted in response to public concerns over potential abuses of the
privacy of health information. Implementation and oversight of the Privacy Rule are the
responsibility of the HHS Office for Civil Rights. Additional information about how the Privacy
Rule impacts research can be found at http://privacyruleandresearch.nih.gov and at
http://www.hhs.gov/ocr/privacy/
1999: The Death of Jesse Gelsinger
On September 17, 1999, 18 year-old Jesse Gelsinger became the first subject in a gene transfer
clinical trial to die from a reaction to a recombinant viral vector. Jesse suffered from a
deficiency of ornithine-transcarbamylase (OTC), a necessary enzyme, and enrolled in a Phase I
dose-escalation trial at the University of Pennsylvania. The clinical trial involved the injection of
an adenoviral vector containing the gene. Jesse died after receiving the injection.
Subsequent investigations found that the Principal Investigator was an inventor for the
technology used in the trial and held equity in the start-up company to which the technology
was licensed. This case brought significant attention to the issue of financial conflicts of interest
in research. Additional information about financial conflict of interest can be found on the NIH
Conflict of Interest (COI) Page. The HHS regulations governing conflicts of
interest,”Responsibility of Applicants for Promoting Objectivity in Research for Which PHS
Funding is Sought”, can be found at 42 CFR 50, Subpart F.
2000: The Office of Human Research Protections
The Office of Human Research Protections (OHRP) was elevated to the level of the U.S.
Department of Health and Human Services, replacing the NIH Office for Protection from
Research Risks (OPRR). The OHRP provides leadership for all 17 Federal agencies that carry out
research involving humans under the Common Rule regulations. The Office has regulatory
authority for the protection of human subjects in research and policies and procedures for
Institutional Review Boards.
To learn more about OHRP, visit http://www.hhs.gov/ohrp/
2004: The Secretary’s Advisory Committee on Human Research Protections
The Secretary’s Advisory Committee on Human Research Protections (SACHRP) was established
to provide expert advice and recommendations to the Secretary of Health and Human Services
and the Assistant Secretary for Health on issues and topics pertaining to or associated with the
protection of human research subjects. See http://www.hhs.gov/ohrp/sachrp.
Course Regulations
What This Module Covers:
•
•
The Belmont Report – Ethical Principles and Guidelines for the Protection of Human
Subjects of Research
HHS Regulations for the Protection of Human Subjects, 45 CFR 46
The Objectives For This Module Are:
•
•
To identify the three principles of ethical human subjects research identified in the
Belmont Report
To comprehend the current HHS regulations, including:
o Risks associated with participation in research and appropriate protections
against risks
o Vulnerable populations that need specific protections
o Situations in which research involving humans is exempt from regulatory
requirements
The Belmont Report
Following the public outrage over the Syphilis Study at Tuskegee, Congress established the
National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research in 1974. The National Commission was charged with:
1. Identifying the ethical principles to guide all research involving human subjects
2. Developing guidelines for the conduct of ethical research involving human subjects
In 1979, the National Commission drafted The Belmont Report – Ethical Principles and
Guidelines for the Protection of Human Subjects of Research.
The Belmont Report identified three principles essential to the ethical conduct of research with
humans:
1. Respect for persons
2. Beneficence
3. Justice
These three basic principles serve as the foundation of the current HHS regulations and
guidelines for the ethical conduct of human subjects research supported by HHS.
Respect for Persons
“To respect autonomy is to give weight to the autonomous person’s considered opinions and
choices while refraining from obstructing his or her actions…” -Belmont Report
The principle of respect for persons can be broken down into two basic ideas:
1. Individuals should be treated as autonomous agents
2. Persons with diminished autonomy are entitled to additional protections
The challenges in applying the Belmont principle of respect for persons are in:
• Making sure that potential participants comprehend the risks and potential benefits of
participating in research
• Avoiding influencing potential participants’ decisions either through explicit or implied
threats (coercion) or through excessive compensation (undue influence)
Beneficence
“Persons are treated in an ethical manner not only by respecting their decisions and protecting
them from harm, but also by making efforts to secure their well-being. Such treatment falls
under the principle of beneficence. The term beneficence is often understood to cover acts of
kindness or charity that go beyond strict obligation. In this document, beneficence is
understood in a stronger sense, as an obligation” -Belmont Report
Two general rules have been articulated as complementary expressions of beneficent actions:
1. Do no harm
2. Maximize possible benefits and minimize possible harms
The challenge inherent in applying the Belmont principle of beneficence is how to determine
when potential benefits outweigh considerations of risks and vice versa.
Justice
“Just as the principle of respect for persons finds expression in the requirements for consent,
and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to
moral requirements that there be fair procedures and outcomes in the selection of research
subjects”. – Belmont Report
Justice requires that individuals and groups be treated fairly and equitably in terms of bearing
the burdens and receiving the benefits of research.
The principle of justice may arise in decisions about inclusion and exclusion criteria for
participation in research and requires investigators to question whether groups are considered
for inclusion simply because of their availability, their compromised position, or their
vulnerability — rather than for reasons directly related to the problem being studied.
The challenge of applying the Belmont principle of justice is how to decide which criteria
should be used to ensure that harms and benefits of research are equitably distributed to
individuals and populations.
Review
The Belmont Report identifies three principles essential to the ethical conduct of research with
humans.
Move word or statement under appropriate category in diagram.
page 6 review (TODO)
The HHS Regulations – Protection of Human Subjects
The ethical principles for research involving human subjects described in the Belmont Report
are codified in the Code of Federal Regulations, 45 CFR 46. The NIH follows all Subparts of the
HHS regulations:
Subpart A – Basic HHS Policy for Protection of Human Research Subjects
Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates
Involved in Research
Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving
Prisoners as Subjects
Subpart D – Additional Protections for Children Involved as Subjects in Research
Subpart E – Registration of Institutional Review Boards
Subpart A – Basic HH
