CITI -Social Behavioral Research Questions and Answers

CITI -Social Behavioral Research Questions and Answers What procedures must be described in an agreement called an "assurance of compliance" with OHRP? Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site? If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Nuremberg Code Judged human experimentation conducted by Nazis. Voluntary consent by human subject is absolutely essential Declaration of Helsinki basis of good clinical practices. Addresses research protocols, informed consent, risks/benefits, et plus Belmont Report basic ethical principles for research involving human subjects. -Respect for person's autonomy -Beneficence -Justice Respect for Person individuals treated as autonomous agents, and those with diminished autonomy are entitled protection Beneficence Make effort to secure well-being. -Do not harm -Maximize possible benefits and minimize possible harm/risk Justice Equals be treated equally. -To each person an equal share. -To each person according to individual need. -To each person according to individual effort. -To each person according to societal contribution. -And to each person according to merit. IRB Review to protect the rights and welfare of human subjects by ensuring equitable subject selection, assuring adequate informed consent, assessing and minimizing risks, and maintaining privacy and confidentiality. Exempt Review research with human subjects that generally involves no more than minimal risk. Does not require ongoing review, unless amended st it no longer fulfills the exempt criteria Expedited Review research presents no more than minimal risk. Does not have to be full convened committee. Full Board (convened) Review research that involve more than minimal risk require full board review at a convened meeting at which a quorum of IRB members is present. Must receive approval by majority of members. Research a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. To test a hypothesis with conclusions to be drawn Human subject a living individual ABOUT whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Which of the following studies need IRB approval? Studies collecting data about living individuals. Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee? Exempt Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond. Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is: Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected? The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the Internet confidentiality cannot be absolutely guaranteed. breach of obligation describes an actual violation of a moral or legal duty. Conflict of Interest objective fact situation in which there is increased potential for harm or wrongdoing as a result of compromised independence. The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold: Any equity interest in a publicly held company that exceeds $50,000 Current NIH rules require investigators to disclose details regarding financial conflicts of interest to: Designated institutional officials To ensure that researchers are conducting a study according to IRB requirements, IRBs could: Observe the consent process or research procedures Federal regulations require that additional safeguards have been included in a study to protect the rights and welfare of these subjects: Children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons Research with older adults should include: Provisions for assessing capacity to consent An aging population has resulted in the need to: Include more older adults in research to ensure generalizability of research results Older adults have been excluded from research participation because: Their conditions are considered to confound research protocols Legally Authorized Representatives (LARs) should be involved in the consent process when: Prospective subjects are assessed and determined to lack capacity to make consent decisions The informed consent process with older adults can be improved by: Including a limited number of alternatives Clinicians find it difficult to care for older adults because: They have not been included in studies so prescribing drugs involves a lot of unknown risk The diversity in sexuality includes Gays, Lesbians, Heterosexuals, Bisexual people, Pansexual people, and Asexual people Researchers should be particularly sensitive of which of the following when potentially working with GSD subjects, regardless of the type of research? Heteronormative or gendernormative language 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 can "gender expression" tell you about a particular subject? How they interpret their gender identity Parental Permission should be waived for research in GSD youth when: Obtaining permission will disclose GSD status to the parent when the child has not yet disclosed to them AND the disclosure might put the child at risk for violence, bullying or being kicked out of their family home. Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of: Medical vulnerability NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was not included as possibly leading to vulnerability? High potential for individual benefit from participating in research When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Is there a power differential between researchers and subjects? In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: Situational cognitive vulnerability 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. If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: Obtain a waiver of documentation of informed consent. Additional safeguards that may be included in a social and behavioral study may include: Remove all direct identifiers from the data as soon as possible. The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure. Risk of harm in social and behavioral sciences generally fall in three categories, which are: Invasion of privacy, breach of confidentiality, and study procedures What statement about risks in social and behavioral sciences research is most accurate: Risks are specific to time, situation, and culture.