Which study led to the Belmont Report?
The Belmont Report was written in response to the infamous Tuskegee Syphilis Study, in which African Americans with syphilis were lied to and denied treatment for more than 40 years. Many people died as a result, infected others with the disease, and passed congenital syphilis onto their children.
What statement about risks in social and behavioral sciences research is most accurate?
What statement about risks in social and behavioral sciences research is most accurate: Risks are specific to time, situation, and culture. The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure.
Which is an example of a situation where deferential vulnerability might be a factor?
An example of a situation where deferential Vulnerability might be a factor is a physician recruiting his patients.
When evaluating risks of harm IRBs must determine that?
When evaluating risks of harm, IRBs must determine that: Risks are reasonable in relation to anticipated benefits.
Which statement best describes information that must be included in a consent form quizlet?
Respect for Persons, Beneficence, Justice. Which statement best describes information that must be included in a consent form: A description of the research’s potential benefits and risks.
Which statement best describes information that must be included in a consent form?
Which statement best describes information that must be included in a consent form: A description of the research’s potential benefits and risks.
Which of the following is the clearest example of Macroethical issue?
Which of the following is the clearest example of a macroethical issue? Balancing risks and benefits from nanotechnology research.
Which of the following is a key reason why international collaborations can be challenging quizlet?
Correct Answer : Language barriers and cultural differences among collaborators can complicate communication. Comment : A key reason why international collaborations can be challenging is that language barriers and cultural differences among collaborators can complicate communication.
Which if the following is a key reason why international collaborations can be challenging?
Which of the following is a key reason why international collaborations can be challenging? Language barriers and cultural differences among collaborators can complicate communication. It should be discussed early on in the collaboration by the members of the research team.
What is the main function of the Bayh Dole Act?
The Bayh-Dole Act, formerly known as the Patent and Trademark Act Amendments, is a federal law enacted in 1980 that enables universities, nonprofit research institutions and small businesses to own, patent and commercialize inventions developed under federally funded research programs within their organizations.
What are the three main goals of data lifecycle management DLM )?
What are the three main goals of data lifecycle management (DLM)?
- Data security and confidentiality. Given the potential value of data in both regulated markets and in black markets, access to these must be safeguarded against cyber criminals.
- Availability at all times.
- Long-term structural integrity.
Why is data lifecycle management important?
A data lifecycle management strategy places value on your data as it moves through the various stages of its lifecycle. Once data is no longer useful for production environments, it can be moved to less costly storage, whether that is on-premises, in the cloud or in a hosted off-site tape vault.
What are the three stages of the information lifecycle?
In general, there are three stages in the information lifecycle:
- The creation and/or acquisition of the data.
- The publication of the data.
- The retention and/or removal of the data.
What is the main focus of NIH’s conflict of interest policy?
The purpose of the rule is to “promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial …
Who determines if a conflict of interest can be managed?
Points Earned : 0 Take the next required module : Collaborative Research (RCR-Basic) Question 1 Question : The entity that normally is supposed to determine whether an academic researcher’s conflict of interest can be managed is: Your answer : A conflict of interest committee Correct Answer : A conflict of interest …
What is NIH conflict of interest?
A financial conflict of interest exists when the recipient’s designated official(s) reasonably determines that an investigator’s significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
What is an institutional conflict of interest?
Institutional conflicts of interest arise when an institution’s own financial interests or those of its senior officials pose risks of undue influence on decisions involving the institution’s primary interests. In situations like these, an individual’s financial relationship also implicates the institution’s interests.
What is an apparent conflict of interest?
An “apparent” conflict of interest, however, is where it appears to members of the public that a public servant’s private interests could improperly influence the performance of his or her duties. “Private interests” are not limited to financial interests.
What is personal conflict of interest?
Personal conflict of interest means a situation in which a covered employee has a financial interest, personal activity, or relationship that could impair the employee’s ability to act impartially and in the best interest of the Government when performing under the contract.
Which of the following is a standard core component of an institutional conflict of interest policy?
Which of the following is a standard core component of an institutional conflict of interest policy? A section on the disclosure process. No federal agency has promulgated institutional conflict of interest regulations.
How do you identify conflict of interest?
In assessing a potential conflict of interest situation, consider: “Would a reasonable, disinterested observer think that an individual’s competing personal interests’ conflict appear to conflict, or could conflict in the future, with the individual’s duty to act in the University’s best interests?”
What are the elements of conflict of interest?
To avoid common misunderstandings of the concept that can lead to misplaced and ultimately ineffective or counterproductive policies, the committee stresses the importance of each of the three main elements of a conflict of interest: the primary interest, the secondary interest, and the conflict itself.
What is an example of a conflict of interest?
A conflict of interest involves a person or entity that has two relationships competing with each other for the person’s loyalty. For example, the person might have a loyalty to an employer and also loyalty to a family business. Each of these businesses expects the person to have its best interest first.
How do you write a conflict of interest?
Authors should also disclose any conflict of interest that may have influenced either the conduct or the presentation of the research to the editors, including but not limited to close relationships with those who might be helped or hurt by the publication, academic interests and rivalries, and any personal, religious …
What is a conflict of interest in simple terms?
What is a Conflict of Interest? A conflict of interest occurs when an individual’s personal interests – family, friendships, financial, or social factors – could compromise his or her judgment, decisions, or actions in the workplace.
How do you create a conflict of interest?
Declaring a Conflict of Interest – All Staff
- The matter to which the conflict relates, including dates of the conflict arising and the disclosure being made;
- The nature and details of conflict (actual, potential or perceived, pecuniary/non-pecuniary etc);
- Your proposed plan to manage or address the conflict;
- Your details;
- Your supervisor’s details.
What are the risks associated with SBR?
Most risks of harm from SBR research results from invasion of privacy and breaches of confidentiality. Researchers should design strategies to minimize the possibility of breaches of confidentiality and inform all subjects about the potential for these breaches especially in a focus group situation.
Which of the following is considered a SBR data?
Interviews is the correct answer.
What is SBR data?
Interviews, surveys, and participantobservation are techniques designed to collect informationabout attitudes, beliefs, and behavior and are data collectionmethods typically used by SBR researchers. Points Earned 1 Congratulations!
What is SBR data collection?
Biomedical and clinical researchers sometimes incorporate SBR questions and methodologies into their physiological research. SBR is characterized by data collection methods such as questionnaires, interviews, focus groups, direct or participant observation, and non-invasive physical measurements.
What is the IRB charged with quizlet?
The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects.
What is SBR research?
Studies that test random samples of the population and that involve a control group are scientifically controlled. SBR is defined as including ex- perimental or quasi-experimental studies, with a pref- erence for randomized controlled trials (NCLB, 2002).
What is the primary purpose of a certificate of confidentiality?
The primary purpose of a Certificate of Confidentiality (CoC) is to allow institutions and agencies to protect identifiable and sensitive research information on the subject of a study. The main principle of the CoC is that investigators cannot be compelled to disclose any data under the protection of the certificate.
Which choice best describes the purpose of most pharmacogenomic research quizlet?
Which choice best describes the purpose of most pharmacogenomic research? Investigator A has biological specimens that are coded and linked to identifiers of the source individuals.
Which of the following is something an IRB should do with respect to review of GSD research?
Which of the following is something an IRB should do with respect to review of GSD research? Seek consultants with expertise in specific segments of GSD communities to provide information on research in those communities.
What is juridic vulnerability?
Juridic vulnerability calls attention to the formal authority relationships that often characterize social structures. This distinctive vulnerability—the juridic fact of their subordination to the authority of another—can call into question the validity of their consent.
Which is true inducements in research?
Which is true of inducements in research? Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
What is the main risk of harm in big data research characterized as?
The main risk to human subjects in these contexts, as identified by IRBs, has been breach of confidentiality and any resulting psychological, social, legal, or financial harm.
What are research inducements?
24. Undue inducement occurs when a person makes a choice in circumstances in which external factors are likely to have an inappropriate influence on his or her decision-making process. 25. The choice made by the person is not entirely free because it is unduly influenced by these external factors.
What should happen if a participant withdraws from your research?
If a subject withdraws from the research intervention for a study and does not consent to continued follow-up of associated clinical outcome information, the investigator cannot access the participant’s medical or other confidential records requiring the participant’s consent, for purposes related to the study.
When can a research participant choose to withdraw from a research study?
What does it mean when a subject withdraws from a research study? Subjects have the right to withdraw from (i.e., discontinue participation in) research at anytime (45 CFR 46.116(a)(8)).
How do participants withdraw from a study?
A participant can leave a research study at any time. When withdrawing from the study, the participant should let the research team know that he/she wishes to withdraw. A participant may provide the research team with the reason(s) for leaving the study, but is not required to provide their reason.
Why is withdrawing Right important?
The right to withdraw is a central tenet of medical research ethics. It protects the autonomy of participants (Gertz [2008]) and indeed, the option for an individual to withdraw is a measure of whether participation is voluntary (Wertheimer [1996]).
Which right is withdrawn?
The right to withdraw is a concept in clinical research ethics that a study participant in a clinical trial has a right to end participation in that trial at will.
What is freedom to withdraw?
one of the basic rights of research participants that is ensured by an institutional review board. Freedom to withdraw allows a research participant to drop out of a study at any time without penalty.
When can participants withdraw their consent?
Subject withdrawal occurs when a subject voluntarily withdraws his or her consent to participate in a study, or when a Principal Investigator (PI) ends a subject’s study participation. 45 CFR 46.116(a)(8) gives human subjects the right to withdraw their informed consent to participate in a research study at any time.
When can research participants withdraw from a study quizlet?
9. A client may withdraw participation in study at any time for any reason, after signing a consent form.
What is protection of participants in research?
Protection of Participants This means you must not embarrass, frighten, offend or harm participants. Normally, the risk of harm must be no greater than in ordinary life, i.e. participants should not be exposed to risks greater than or additional to those encountered in their normal lifestyles.