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.
How do you protect participants in a research study?
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.
What is protecting human research participants?
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.
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.
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.
How do you protect participants in qualitative research?
- Keep the client confidential. …
- Protect personally identifiable information. …
- Separate clients and respondents. …
- Maintain confidentiality beyond the focus group.
Why is it important to protect 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.
What are the rights of research participants?
- To have enough time to decide whether or not to be in the research study and to make that decision without any pressure from the people who are conducting the research.
- To refuse to be in the study at all, and to stop participating at any time after you begin the study.
Where can you find information about protecting the rights and welfare of research participants?
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 type of study could put human participants at risk?
Nearly
any kind
of study with human participation has the potential for risk, whether the risk is physical, psychological, or reputational.
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 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.
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 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.
Which of the following is a measure researchers can use to protect the confidentiality of subject data quizlet?
Which of the following is a measure researchers can use to protect the confidentiality of subject data?
Keep sensitive and identifiable data in encrypted files on a password protected hard drive
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