In the United States, regulations protecting human subjects first became effective on May 30, 1974. Promulgated by the
Department of Health, Education and Welfare
(DHEW), those regulations raised to regulatory status NIH’s Policies for the Protection of Human Subjects, which were first issued in 1966.
When was human subject research first regulated by law?
Congress’s first legislation to protect the rights and welfare of human subjects was the National Research Act of
1974
, which created the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, which issued the Belmont Report.
Which of the following is a set of U.S. regulations that govern human subjects research?
The Human Subject Protection Federal Regulatory Framework
Published on April 18, 1979, the Belmont Report was the work product of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was created in 1974, as part of the National Research Act.
When was the first institutional review board established?
On
July 12, 1974
, the National Research Act established the existence of IRBs to review biomedical and behavioral research involving human subjects.
Who regulates human subject research?
Office for Human Research Protections (OHRP)
OHRP is part of
the U.S. Department of Health and Human Services (HHS)
. OHRP oversees and enforces the Common Rule and other HHS regulations for protecting people in research that is funded with HHS money.
Why is it important to protect human subjects in research?
Advances in human health and welfare ultimately depend on research with human subjects. Properly controlled studies with human subjects are essential to
verify any conclusions
about normal physiology, mechanisms of disease, effectiveness of treatment, learning, or behavior.
What are the five ethics of research?
- Discuss intellectual property frankly. …
- Be conscious of multiple roles. …
- Follow informed-consent rules. …
- Respect confidentiality and privacy. …
- Tap into ethics resources.
What is 45 CFR 46 Subpart A?
Subpart A, also known as the Common Rule,
provides a robust set of protections for research subjects
; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration. The Common Rule, subpart A, was revised in recent years.
Who is subject to the Common Rule?
The Common Rule applies to
any research conducted or supported by a federal agency that has codified the regulation
, except if the research falls into one of the categories of exceptions listed below.
What are the common rules?
The Common Rule is
the baseline standard of ethics by which any government-funded research in the US is held
; nearly all academic institutions hold their researchers to these statements of rights regardless of funding.
What was the first IRB?
The IRB began in
1974
when the National Research Act was signed into law, the Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
What caused the IRB to form?
The
recognition of the need for guidelines dealing with human subjects in research
emerged following the Nuremberg trials, where the medical experimentation abuses of World War II Nazi doctors came to public attention.
Who is the IRB comprised of?
An IRB consists of
at least five members of varying backgrounds
. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific.
How can we protect human subjects in research?
- Review the Office of Human Research Protections (OHRP) Web site. …
- Consult with your IRB. …
- Carefully review the PHS 398. …
- Determine your own institutional policy regarding when to submit to your IRB. …
- Understand Peer Reviewers’ options with regard to human subject protections.
What does OHRP stand for?
The
Office for Human Research Protections
(OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
What is protection of human subjects in research?
A section labeled “Protection of Human Subjects” which describes
the proposed involvement of human subjects
, including an assessment of risk, the steps taken to protect the subjects from risk, potential benefits from the study to the subjects and others and the importance of the knowledge to be gained from these studes …
