Which federal regulation or law governs how researchers can obtain data about subjects’ disciplinary status in school from academic records?
The Family Educational Rights and Privacy Act
.
When required the information provided to the data subject in a Hipaa disclosure?
When required, the information provided to the data subject in a HIPAA disclosure accounting …
must be more detailed for disclosures that involve fewer than 50 subject records
. Can qualify as an activity “preparatory to research,” at least for the initial contact, but data should not leave the covered entity.
Which of the following is a set of US 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.
What action can he expect by the IRB?
The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB?
The IRB will not review this study because
it is not research as defined by the federal regulations. You just studied 35 terms!
Which of the following is an additional regulation that governs research in private and public schools if they receive federal funds?
However,
the Family Educational Rights and Privacy Act (FERPA)
is a comprehensive law that applies broadly to information collected in public agencies or schools that receive federal education funds.
A covered entity is permitted, but not required, to use and disclose protected health information, without an individual’s authorization, for the following purposes or situations: (1) To the Individual (unless required for access or accounting of disclosures); (2) Treatment, Payment, and Health Care Operations; (3) …
Which of the following are considered incidental disclosures?
The HHS defines an incidental disclosure as the following: “An incidental use or disclosure is
a secondary use or disclosure that cannot reasonably be prevented, is limited in nature
, and that occurs as a result of another use or disclosure that is permitted by the Rule.
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.
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 are the ethical rules today regarding research?
In practice, these ethical principles mean that as a researcher, you need to: (a)
obtain informed consent from potential research participants
; (b) minimise the risk of harm to participants; (c) protect their anonymity and confidentiality; (d) avoid using deceptive practices; and (e) give participants the right to …
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
.
When an original consent form has been lost?
If a signed informed consent form has been lost, consider
contacting the participant to establish if they
are able to resign the consent form or provide a copy of the consent form they initially retained. The approach taken to resolve the issue should be clearly documented and retained as part of the trial records.
Which type of research does not need to get an IRB approval?
Publicly available data
do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”
Who is considered a child according to the federal regulations?
According to federal regulations, “children” are defined as:
Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted
.
What is the term for management controls that are?
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
.
Suppressing, blurring, and masking
are three methods used at various times to prevent the disclosure of FERPA protected information. These methods are often used in reporting research results.
