CITI Training: Students Research
Students in Research Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)? A. Exempt B. Expedited C. Convened/Full Board
A. Exempt Exempt research is human subjects research that is "exempt" from the Common Rule provisions. Per federal guidance, the recommendation is that researchers should not be able to self-determine whether a study qualifies for exemption. Institutional policy should clearly designate who is responsible for making exemption determinations - and it could be an IRB member or experienced staff person with knowledge of the exemption categories and the research activity. Expedited and convened reviews both require IRB approval.
Research in Public Elementary & Secondary Schools Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? A. Directory information. B. Citizenship. C. SAT scores. D. Religious affiliation.
A. Directory information. Schools may disclose, without consent, directory information such as a student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. However, schools must tell parents and eligible students that directory information is not protected, and they must allow parents and eligible students a reasonable amount of time to request that the school not disclose directory information about them. FERPA allows schools to disclose identifiable records without permission to certain parties, including organizations conducting research initiated by a school district or a state department of public instruction.
Students in Research Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply. A. Protecting the rights and welfare of human subjects. B. Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects. C. Reviewing manuscripts prior to submission for publication. D. Reviewing subject recruitment materials and strategies. E. Conducting inquiries into scientific misconduct.
A. Protecting the rights and welfare of human subjects. & B. Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects. & D. Reviewing subject recruitment materials and strategies. Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, the IRB is charged with protecting the rights and welfare of human subjects and reviewing and overseeing human subjects research. IRBs do not investigate scientific misconduct nor do they review manuscripts prior to submission for publication.
Students in Research A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type of review? A. Convened Review B. Determination for Exemption C. Expedited Review D. Not Human Subjects
B. Determination for Exemption This study would qualify for a determination for exemption (under Category 2). This exemption category states that any research study involving educational tests, surveys, interviews, or observations of public behavior can be deemed exempt, unless the data is recorded in a way that identifies human subjects, directly or through identifiers linked to the subjects, and disclosure of any human subjects' responses outside the research could reasonably place participants at risk of criminal or civil liability or damage their financial standing, employability, or reputation.
Students in Research Which of the following studies would need IRB approval? A. Studies that involve cadavers. B. Studies collecting identifiable information about living individuals. C. Studies that use data collected for internal department use only and the aim of the study is quality improvement for the department only. D. Studies that use publicly available census data from the years 1890-1910.
B. Studies collecting identifiable information about living individuals. If a study intends to collect identifiable or information about a living individual, you would need IRB review and approval.
Research in Public Elementary & Secondary Schools PPRA gives parents some level of control over their child's: A. Ability to opt out of health education (specifically, sexual health education) B. Educational records C. Participation in third-party survey research or exposure to instructional materials developed by researchers D. Medical records
C. Participation in third-party survey research or exposure to instructional materials developed by researchers PPRA gives parents some level of control over their child's participation in third-party survey research or exposure to instructional materials developed by researchers. FERPA gives parents certain rights with respect to their children's educational records. The ability to opt out of health education would be an institutional, local or state law, and is not covered in this module about research. The access to medical records would be covered under Health Insurance Portability and Accountability Act (HIPAA) and is not covered in this module as it does not relate to research in public schools.
Students in Research A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review? A. Not Human Subjects B. Determination for Exemption C. Expedited Review D. Convened Review
D. Convened Review This study would qualify for convened review because the IRB must conduct a careful analysis. The study involves an interview where the data collected could have an impact on the principals' careers and it contains subject identifiers.
Research in Public Elementary & Secondary Schools In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools: A. FERPA, PPRA, and No Child Left Behind Act B. PPRA and Subpart D of the federal regulations C. FERPA and Subpart D of the federal regulations D. FERPA, PPRA, and Subpart D of the federal regulations
D. FERPA, PPRA, and Subpart D of the federal regulations FERPA, PPRA, and Subpart D of the federal regulations also govern research in the public schools.
Research in Public Elementary & Secondary Schools If research in a private school is directly funded by the Department of Education, then: A. PPRA only applies if the research is more than minimal risk. B. PPRA only applies if the research is no more than minimal risk. C. PPRA does not apply. D. PPRA applies.
D. PPRA applies. If research in a private school is directly funded by the Department of Education, PPRA applies, regardless of the risk level of the research (more than minimal or no more than minimal). A private school that does not receive any federal funding is not subject to the provisions of FERPA or PPRA.
Research in Public Elementary & Secondary Schools Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? A. The Protection of Pupil Rights Amendment. B. Subpart D of 45 CFR 46. C. The No Child Left Behind Act. D. The Family Educational Rights and Privacy Act.
D. The Family Educational Rights and Privacy Act. A student's disciplinary status is part of his or her school record. In accordance with FERPA, schools must usually have written parental permission before they can release data from school records to researchers. The Protection of Pupil Rights amendment is concerned with the kinds of questions that may be included in surveys and interviews with minor school children. The No Child Left Behind Act is a specific amendment to PPRA that gives parents additional rights over the content of research materials. Subpart D of 45 CFR 46 is concerned with the rights of children as research subjects and does not regulate school systems.
