45 CRF 46 Protection of Human Subjects (DHHS)
16.49. True or False? Nothing in 45 CFR 46 is meant to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.
The correct answer is: True
16.52. True or False? In some cases where the informed consent documentation requirement is waived, an IRB may require the investigator to provide subjects with a written statement regarding the research.
The correct answer is: True
16.57. True or False? Federal funds administered by a department or agency may not be expended for research involving human subjects unless the requirements of 45 CFR 46 have been met.
The correct answer is: True
16.58. True or False? A federal agency reserves the right to suspend or terminate any project if the agency head finds that the institution has materially failed to comply with the terms of 45 CFR 46.
The correct answer is: True
16.60. True or False? Although there are exceptions for obtaining a father's consent, prior to enrolling a pregnant woman into a federally-funded research project, the researcher must normally obtain bother her consent and the consent of the father.
The correct answer is: True
16.62. True or False? Federally funded research activities directed toward an in-utero fetus typically requires informed consent of both the mother and father, unless an exception applies.
The correct answer is: True
16.63. True or False? Federal regulations generally prohibit research on a viable ex-utero fetus, unless the research is planned to enhance the possibility of survival.
The correct answer is: True
16.7. True or False? Institutions which have DHHS-approved assurances on file are required to abide by the provisions of title 45 CFR part 46 subparts A-D.
The correct answer is: True
16.70. True or False? Even though a child may assent, the child's parent(s) or guardian(s) permission is required prior to enrolling children into research studies, unless a special exception applies.
The correct answer is: True
16.8. True or False? Exemptions from applicability of 45 CFR 46 do not apply to research in populations requiring additional protections which include prisoners, fetuses, pregnant women, or human in vitro fertilization.
The correct answer is: True
16.32. True or False? An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been affiliated with unexpected serious harm to subjects.
The correct answer is: True. Additionally, any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials and the department or agency head.
16.9. Describe the definition of research in the DHHS regulation 45 CFR 46?
The correction answer is: Research means a systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
16.56. What decisions may a federal agency make in regard to an application submitted for funding that involves human subjects?
The department or agency head may approve or disapprove the application or proposal or enter into negotiations to develop an approvable one.
16.44. Name the requirements for informed consent regarding language.
The language must be understandable to the subject or the representative and may not include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
16.41. How long must an IRB retain its records, and to whom does the IRB provide access to the records?
The records shall be retained for at least 3 years and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner.
16.54. What steps must be taken by institutions or investigators supported by federally funded research that is undertaken without the intention to involve human subjects, that later proposes to involve human subjects?
The research must first be reviewed and approved by an IRB, a certification submitted by the institution to the department or agency, and the final approval given to the proposed change by the department or agency.
16.55. All applications and proposals involving human subjects submitted to a federal department or agency for funding will be reviewed by appropriate persons. What will the evaluation take into consideration?
The risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.
16.36. For federally funded research, minutes of IRB meetings are required to include sufficient information to define which items?
1). Attendance at the meetings. 2). Actions taken by the IRB, including the vote with the number of members voting for, against, and abstaining. 3). The basis for requiring changes in or disapproving research. 4). A written summary of the discussion of controverted issues and their resolution.
16.30. The IRB must pay particular attention to ensure additional safeguards have been taken for vulnerable subjects in federally supported research. List at least three groups of vulnerable subjects of concern.
1). Children. 2). Prisoners. 3). Pregnant women. 4). Mentally disabled persons. 5). Economically or educationally disadvantaged persons.
16.22. The requirements for IRB review of research in 45 CFR 46.109, are the same as those in 21 CFR 56, with the exception of requirements for waiver of informed consent in emergency research, which applies only to FDA-governed research. To learn these requirements, study the questions identified on the other side of this card.
Study questions 4-25, 4-26, 4-29, 4-30, 4-32 and 4-33.
16.26. The requirements for utilizing an expedited IRB review process for minor changes and informing the full IRB are essentially the same as 21 CFR 56. To learn these requirements, study the questions identified on the other side of this card.
Study questions 4-37 and 4-38.
16.27. The criteria for IRB approval of federally supported research is similar to that required in 21 CFR 56.112. To learn this material, study the questions identified on the other side of this card.
Study questions 4-40, 4-41 and 4-42.
16.20. The IRD membership requirements for 45 CFR 46.107 are the same as those of 21 CFR 56.107. To learn these requirements, study the questions identified on the other side of this card.
Study questions 4-9 through 4-19.
16.47. Many of the required elements of informed consent from 21 CFR 50 and 45 CFR 46 are essentially the same. To study these elements, review the questions located on the back of this card.
Study questions: 2-36 through 2-39, 2-41 and 2-42, 2-44 through 2-48, 2-51 and 2-52.
16.50. Many of the requirements for documenting informed consent are the same for 21 CFR 50 as they are for 45 CFR 46. To study these requirements, review the questions located on the back of this card.
Study questions: 2-50, 2-53 through 2-55, 2-57 through 2-59.
16.71. Whose responsibility is it to determine whether children are capable of assenting to participate in a research trial?
The IRB.
16.65. Under what conditions can modifications related to the requirements of additional protections for research related to fetuses, pregnant women and in vitro fertilization be made?
The Secretary of Health and Human Services may waive certain requirements, only after approval of an ethical advisory board, IRB approval, an opportunity for public comment and publication of the waiver in the Federal Register.
16.23. For federally supported research, who is responsible for publishing a list of categories of research that may be reviewed by the IRB through an expedited review procedure?
The Secretary, Health and Human Services, publishes the list in the Federal Register. A copy of the list is available from the Office for Protection from Research Risks (renamed the Office of Human Research Protection)
16.10. For federally supported research, "human subject" means a living individual with whom an investigator (whether professional or student) conducting research obtains either of which two items?
The correct answer is: 1). Data through intervention or interaction with the individual. or 2). Identifiable private information.
16.12. Regulations for federally supported research the term "private information" includes two types of information. Name them
The correct answer is: 1). Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. 2). Information which has been provided for specific purposes by an individual can reasonably expect to not be made public (i.e. a medical record).
16-1. What are the types of human drug research are required to comply with DHHS regulations?
The correct answer is: All studies that are conducted by, supported or are otherwise subject to regulation by any federal department or agency that defines this regulation as applicable.
16.59. True or False? Since it is an IRB responsibility, federal agencies are not allowed to impose additional conditions prior to or at the time approval of a research project, if the department or agency determines that the additional conditions are necessary for the protection of human subjects.
The correct answer is: False. Additional conditions may be imposed at the discretion of the agency.
16.34. True or False? An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.
The correct answer is: False. Approval of the department or agency head is required prior to entering such agreements.
16.45. True or False? Subject matter describing the extent, if any, to which confidentiality of records identifying the subject will be maintained must be included in all informed consent documents.
The correct answer is: True
16.24. The requirements permitting expedited review of research by an IRB are the same as those in 21 CFR 56. To learn these requirements, study the question mentioned on the other side of this card.
Study question 4-36.
16.21. For federally funded research, the requirements for IRB decisions are based on the members available to vote are the same as those in 21 CFR 56.108. To learn these requirements, study the questions identified on the other side of this card.
Study questions 4-23 and 4-24.
16.51. An IRB can waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds one of two conditions are present. Name these conditions.
1). The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. 2). The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
16.61. No pregnant woman is allowed to participate as a subject in a research study unless what conditions are present?
1). The purpose of the research is to meet the health needs of the mother while minimizing the health risks to the fetus. 2). The risk to the fetus is minimal.
16.43. When obtaining informed consent from prospective research subjects, investigators are required to ensure certain circumstances or conditions are present. Name these circumstances or conditions.
1). The subject has sufficient opportunity to consider whether to participate. 2). The possibility that coercion or undue influence is minimized.
16.68. What is the DHHS definition of "assent" by a child?
A child's affirmative agreement to participate in research. Mere failure to object, absent of affirmative agreement, should not be construed as assent.
16.14. Explain the term "certification" with respect to federally support research.
Certification is the official notification by an institution to the supporting department or agency, in accordance with the requirements of 45 CFR 46 that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
16.15. What information must each institution participating in federally supported research covered by 45 CFR 46 provide to the department or agency head?
Each institution must either submit a written assurance, or provide documentation of the existence of a current federal wide assurance that is appropriate for the research in question that is on file with the Office of Human Research Protection (OHRP)
16.69. Explain the DHHS definition of "children".
Persons who have not attained the legal age for consent to treatments or procedures involved in research under the applicable law of the jurisdiction where the research will be conducted.
16.53. Certain applications for federal funding may be submitted without prior IRB approval, if the proposal does not include definite plans for involvement of human subjects. For example, human subject research would be dependent upon prior research, such as animal or laboratory research. However, prior to involving humans in research, what must take place?
IRB review approval must be obtained, and certification of such approval must be submitted by the grantee institution to the department or agency funding the research.
16.66. Why is the basic premise for providing additional protection to prisoners who are research subjects put into place?
It is believed that prisoners, due to their incarceration, are under constraints that may inhibit their ability to make a truly voluntary decision to participate in research.
16.46. Informed consent should always include a statement that participation is voluntary and that refusal to participate involves what?
No penalty or loss of benefits to which the subject is otherwise entitled and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
16.48. An IRB may approve a modified consent procedure or form, or waive the requirement to obtain informed consent for certain types of federally supported research, provided what criteria are met?
Provided that the IRB finds and documents that the research meets the exemption(s) defined in 45 CFR 46.
16.67. Name two of the four types of federally funded research that prisoners may be used as subjects.
Research involving: 1). Possible causes, effects, and processes of incarceration and criminal behavior. 2). Prisons as institutional structures or prisoners as incarcerated persons. 3). Conditions particularly affecting prisoners. 4). Practices aimed at improving the health or well being of prisoners.
16.64. What laws govern the conduct of federally funded research involving a deceased fetus, fetal material, or placenta?
State and/or local laws.
16.40. What information is an IRB required to preserve in its records that it receives from investigators regarding new information for study subjects?
Statements of significant new findings provided to subjects.
16-2. True or False? Is it possible for direct or indirect identification of human subjects in education research settings can be the only condition under which education research is typically subject to the requirements of 45 CFR 46.
The correct answer is: False. If disclosure of information from cognitive research could reasonably place the study subjects at risk of criminal or civil liability, or be damaging to their financial standing, employability or reputation, the research is also subject to the requirements of 45 CFR 46.
16.37. True or False? IRBs reviewing federally supported research are required to keep records of continuing review activities, only if the research is approved to continue.
The correct answer is: False. Records of all continuing review must be retained.
16.29. True or False? Determination of the adequacy of provisions to protect the privacy of subjects and to maintain the confidentiality of data, therefore, are not IRB responsibilities and do not impact approval of research.
The correct answer is: False. The IRB should determine these provisions are present in the research.
16.6. Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of 45 CFR 46 to specific research activities which are otherwise covered by this policy, provided what is done with the waiver?
The correct answer is: Provided that advance notice is sent to the Office for Protection from Research Risks (renamed as Office of Human Research Protection), and published in the Federal Register or as otherwise provided in department or agency procedures.
16.5. For US-funded studies conducted outside of the US, a department or agency head can determine that the procedures prescribed by a local institution afford protections that are at least equivalent to those in 45 CFR 46, he/she may approve the substitution of the foreign procedures provided that what occurs?
The correct answer is: Provided the approval is published in the Federal Register or as provided in department or agency procedures.
16.11. True or False? For research that is federally supported, the term "intervention" includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
The correct answer is: True
16.13. True or False? Private information must be individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order to obtain the information to constitute research involving human subjects.
The correct answer is: True
16.16. True or False? Federal Departments and agencies will conduct or support research covered by 45 CFR 46, only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB, granted for in a valid assurance, and will be subject to continuing review by the IRB.
The correct answer is: True
16.17. True or False? Assurances applicable to federally supported or conducted research are required to include a statement of principles ascending the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to federal regulation.
The correct answer is: True
16.18. True or False? Assurances applicable to federally supported or conducted research are required to include specification of one or more IRBs established in accordance with the requirements of 45 CFR 46, and for which provisions are made for meeting space and sufficient staff to support the IRB's review and record keeping duties.
The correct answer is: True
16.19. True or False? Assurances applicable to federally supported or conducted research are required to include written procedures which an IRB will follow.
The correct answer is: True
16.25. True or False? A federal department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure.
The correct answer is: True
16.28. True or False? When appropriate, an IRB is required to determine whether or not, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
The correct answer is: True
16.3. True or False? Research, which involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or indirectly, is not subject to the requirements of 45 CFR 46
The correct answer is: True
16.31. True or False? Institutions may require approvals in addition to the IRB approval, but may not approve the research if it has not been approved by an IRB.
The correct answer is: True
16.33. True or False? The IRB is responsible for ensuring that legal informed consent will be gathered for all clinical trial subjects.
The correct answer is: True
16.35. True or False? An institution, or when appropriate, an IRB, is required to prepare and maintain copies of all research proposals reviewed, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
The correct answer is: True
16.38. True or False? Maintaining copies of all correspondence between the IRB and investigators and a detailed list of IRB members that complies with federal regulations is requirement for all IRBs.
The correct answer is: True
16.39. True or False? IRBs are required to maintain written operating procedures.
The correct answer is: True
16.4. True or False? The requirements in 45 CFR 46 do not affect any state, local or foreign laws or regulations which may otherwise be applicable and which may provide additional protections for human subjects.
The correct answer is: True
16.42. True or False? Unless a federal policy permits otherwise, no investigator may involve a human being as a subject in research covered by 45 CFR 46, unless the investigator has obtained the legally effective informed consent from the subject or the subject's legally authorized representative.
The correct answer is: True
