CITI Training Review: Human Subjects Research Questions and Answers

Example of how the principle of beneficence is applied to a study involving human subjects - AnswerEnsuring that the risks are reasonable in relationship to anticipated benefits Harvard "Tastes, Ties, and Time (T3)" () Study involves this primary ethical violation - AnswerThe researcher's failure to protect research subjects from deductive disclosure (primary ethical violation) "The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male" Study - Answer-The study most directly linked to the establishment of the "National Research Act" (1974) and ultimately the "Belmont Report and Federal Regulations for Human Subject Protection" The Belmont principle of Beneficence - Answer-Requires that: potential benefits justify the risks of harm The Belmont principle of Justice - Answer-Moral Requirement that: there be fair outcomes in the selection of research subjects Identifiable Private Information (according to Federal regulations) - Answer-Data obtained by an investigator about human subjects/living human beings through interaction/intervention with an individual Example of a study that meets the definition of research with human subjects (according to Federal regulations) - Answer-1 - A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression. 2 - A study of twenty 4th grade classrooms in which researchers ask the school to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. 3 - An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. 4 - A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.Example of Public Information - Answer-Census data (final report as published by the Census Bureau) Example of Private Information - Answer-A medical record Example of a study the IRB will not review because it is not research (as defined by the Federal regulations) - Answer-A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. The researcher submits the research proposal to the institution's IRB A subject in a clinical trial experiences a serious, unanticipated adverse drug experience. The investigator should proceed, with respect to the IRB, after the discovery of the adverse event occurrence by: - Answer-Reporting the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB An investigator is required to keep consent documents, IRB correspondence, and research records for: - Answer-A minimum of 3 years after completion of the study Expedited review or a new, proposed study may be used by the IRB if: - Answer-- the study involves no more than minimal risks - AND meets one of the allowable categories of expedited review (specified in Federal regulations) Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: - AnswerThe changes must be immediately implemented for the health and well-being of the subject IRB Continuing Review of an approved protocol must occur: - Answer-at LEAST anually Parental Permission using this example: A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. - Answer-The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their childrenExculpatory Language - Answer-Language which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Exculpatory Language in Informed Consent - Answer-General requirement for Informed Consent is that no informed consent may include any exculpatory language. Example of Exculpatory Language in a consent form: - Answer-"Taking part in the research is voluntary, but if you choose to take the part, you waive the right to legal redress for any research-related injuries." A criterion for waiving informed consent: - Answer-When appropriate, subjects are provided additional pertinent information after the study A waiver of the requirement for documentation of informed consent may be granted when: - Answer-- The only record linking the subject and the research is the consent document - AND the principal risk is a breach of confidentiality Example of a study in which it would NOT be appropriate to provide subjects with information about missing elements of consent: - Answer-A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. As a part of the consent process, researchers are required (by the Federal regulations) to provide subjects with information: - Answer-At the appropriate reading comprehension level