CHRC
Informed Consent correct answersA statement that the study involves research. Explanation of purpose of research. Expected duration of subject's participation. Procedures to be followed. Identification of experimental procedures. Reasonably foreseeable risks or discomforts. Benefits to subject or to others expected. Statement describing confidentiality of records identifying the subject. Disclosure of alternative procedures and treatment. Explanation of Compensation for Injury. Who to contact with questions. Participation is voluntary. Written 8th grade level.
Common Rule correct answersThe ethical principles (i.e., respect of persons, beneficence and justice) that form the foundation of human subjects protections in the US were codified in OHRP regulations in 1991 with The Federal Policy for the Protection of Human Subjects, also known as the Common Rule. 45 CFR Part 46
Good Clinical Practice correct answersInternational ethical and scientific quality standard for human subjects research. Provides a unified standard for the conduct of clinical research that engenders public assurance that the rights, safety, and well-being of human subjects are protected and that the clinical trial data are credible; published by ICH
Inquiry (Scientific Misconduct) correct answersmeans of gathering and initial fact finding to determine whether an allegation or apparent instance of misconduct warrants an investigation ( 42 C.F.R. Part 212 and 42 C.F.R. § 93.307). The institution must complete its inquiry within sixty (60) calendar days of its initiation unless circumstances clearly warrant a longer period.
Scientific Misconduct correct answersDefined as: "Fabrication, falsification, or plagiarism (or "FFP") in proposing, performing, or reviewing research or in reporting research results. Research misconduct does not include honest error or differences of opinion" ( 42 C.F.R. § 93.103 ). "Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented
in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit" ( 42 C.F.R. § 93.103 ). This regulation requires that FFP be a "significant departure" from accepted practices as opposed to the "serious deviation" standard in the previous regulation.
Investigation (Scientific Misconduct) correct answersIf the results of the inquiry reflect a likelihood of scientific misconduct, the institution will begin an investigation within thirty (30) days of the completion of the inquiry. The institutional official must contact the Office of Research Integrity (ORI) director of the decision to begin an investigation on or before the date that the investigation begins ( 42 C.F.R. § 93.310 (b)). The institution must complete the investigation within one hundred twenty (120) days of beginning it.
Scientific Misconduct Investigatory Procedure correct answersNotice of allegation, Pre-Inquiry, Inquiry, Investigation, Notice & Appeals, Risk Management
Respondent correct answersIs a person against whom an allegation of research misconduct is directed or
who is the subject of research misconduct proceedings.
Scientific Misconduct Consequences correct answersInclude debarment, suspension, letters of reprimand, restriction on research activities, special review of all requests for PHS funding, imposition of supervision requirements, termination of grants, certification or attribution of all requests for support and reports to the PHS, and more (42 C.F.R. § 93.407). Moreover, HHS may seek to recover PHS funds spent in support of activities that involved research misconduct. HHS will consider whether the actions were knowing or reckless, whether the actions were part of a pattern or practice of wrongdoing, the impact of the misconduct, the respondent's acceptance of responsibility, and other mitigating circumstances.
Conflict of Interest correct answersConflicts of interest arise when financial or other personal consideration have the potential to compromise or bias professional judgment and objectivity. Conflict of
interest inevitably involve the use of an individual's authority for personal and/or financial gain.
Sunshine Act correct answersRequires manufacturers of drugs, devices and biologics, to track and report (on public websites) any payments of $10 or more made by them to physicians. This provision applies to pharmaceutical companies, biotech firms and medical device manufacturers that have products which are eligible for payment by Medicare, Medicaid or the Children's Health Insurance Program (CHIP).
Effort Reporting correct answersA means of verifying that the percent of effort expended by research personnel on various activities is commensurate with the percentage of salaries and wages charged to those accounts. Effort reporting further verifies that cost sharing commitments were met, total effort commitments were met and that costs were appropriately treated in the indirect cost rate.
Clinical Trial Policy correct answersNational Coverage Determination 310.1 (NCD 310.1) CMS' requirements for coverage for certain "routine care services" that are provided as part of a research study. Coverage Analysis correct answersIs a formalized review of what is within a protocol and study event calendar, and is the best practice to ensure that the protocol-related services are outlined, and, if the services will be billed to insurance, that a rationale is given, which overcomes the implicit presumption that a service required by the protocol is medically necessary for all possible eligible subjects.
Clinical Trial Agreement correct answersIs a contract between an institution and a sponsor. Lays out compensation or financial terms, exhibit incorporating the protocol, and sponsor budget.
Qualifying Clinical Trial (QCT) correct answersClinical research studies that meet the following three criteria, and must also be "deemed": Must evaluate an item or service that falls within a Medicare benefit category and is not statutorily excluded; Must have therapeutic intent; Must enroll participants with diagnosed disease; PLUS Desirable Characteristics The principal purpose of the trial is to test whether the intervention potentially improves the subjects' health outcomes; The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use; The trial does not unjustifiably duplicate existing studies; The trial design is appropriate to answer the research question being asked in the trial; The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully; The trial is in compliance with federal regulations relating to the protection of human subjects; and All aspects of the trial are conducted according to the appropriate standards of scientific integrity.
Clinical Research correct answersA systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.
Clinical Investigation correct answersMeans any experiment that involves a test article and one or more human subjects, and that Either is subject to requirements for prior submission to the FDA or is not subject to requirements for prior submission to the FDA. Does not include non-clinical laboratory studies.
Four Phases Clinical Research correct answers1. Testing a small group of people to determine safety, metabolic and pharmacologic actions in humans (safe dosage and side effects) 2. Study larger group of people to determine efficacy and further evaluation of safety. 3. Determine efficacy in large groups of people by comparing intervention to other standard or experimental interventions to monitor adverse effects and to collect information to allow safe use. 4. Studies done after the intervention has been marketed designed to monitor effectiveness of approved intervention in general population and collect information about adverse effects.
