It was written by
the National Commission for the Protection
of Human Subjects. B. It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.
Under
FDA
regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.
Which entity has been established to protect research participants?
The Institutional Review Board (IRB)
is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
What agency has oversight for this country’s system for protecting human subjects?
On July 12, 1974, Congress signed the National Research Act into law, creating
the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research, and requiring approval by an IRB of human subjects research at any institution receiving DHEW funding.
What is an appropriate method for maintaining confidentiality of private information obtained from human subjects?
What is an appropriate method for maintaining confidentiality of private information obtained from human subjects?
Keeping data in a password-protected database.
What are the three types of IRB review?
IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review:
Exempt, Expedited, and Full
.
What are the three fundamental principles of informed consent?
According to the report, informed consent requires three elements:
information, comprehension and voluntariness
.
What are the different procedures to protect the study participants?
To protect participants’ confidentiality, you should
encrypt computer-based files, store documents (i.e., signed consent forms) in a locked file cabinet and remove personal identifiers from study documents as soon
as possible.
How can you protect participants from harm in research?
- Obtaining informed consent from participants.
- Protecting the anonymity and confidentiality of participants.
- Avoiding deceptive practices when designing your research.
- Providing participants with the right to withdraw from your research at any time.
What is protection of participants in research?
Protection of Participants
Researchers
must ensure that those taking part in research will not be caused distress
. They must be protected from physical and mental harm. This means you must not embarrass, frighten, offend or harm participants.
Who is responsible for protecting human subjects?
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.
Who does the Common Rule protect?
The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B,
additional protections for pregnant women, human fetuses, and neonates
; subpart C, additional protections for prisoners; and subpart D, additional protections for children.
Is the Common Rule a law?
The Common Rule is a
1981 rule of ethics
in the United States regarding biomedical and behavioral research involving human subjects. A significant revision became effective July 2018.
How does the common rule define human subjects?
Common Rule Definition of Human Subject:
HHS regulations define a human subject as
any livingindividual about whom an investigator conducting research obtains information or biospecimens
: … obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
What is PHS funded research?
“PHS‐Funded Research” means
Research funded by or proposed to be funded by the PHS
, including without limitation NIH awards.
What is an autonomous person in research?
The term autonomous means that
a person can make his or her own decisions about what to do and what to agree to
. Researchers must respect that individuals should make their own informed decisions about whether to participate in research.
