Ethical Guidelines and Regulations in Biomedical Research Involving Human Subjects, Exams of Nursing

Download Ethical Guidelines and Regulations in Biomedical Research Involving Human Subjects and more Exams Nursing in PDF only on Docsity! CCRP Exam Prep (300 Questions and Answers). Who was tried in the Nuremburg Military Tribunals and why? - Correct answer Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? - Correct answer After 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seven were sentenced to death and executed 6/2/1948. What historical document was born from the Nuremberg Military Tribunals? - Correct answer The Nuremberg Code (1947) According to the Nuremberg Code (1947), all unnecessary physical and mental suffering and injury... - Correct answer should be avoided According to the Nuremberg Code (1947), voluntary consent of the human subject is... - Correct answer absolutely essential According to the Nuremberg Code (1947), the experiment must yield.... - Correct answer generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in nature According to the Nuremberg Code (1947), animal experimentation should... - Correct answer precede human experimentation According to the Nuremberg Code (1947), no experiment should be conducted if there is reason to believe... - Correct answer death of disabling injury will occur According to the Nuremberg Code (1947), the degree of risk to subject should... - Correct answer never exceed the humanitarian importance of the problem According to the Nuremberg Code (1947), risk to subjects should be minimized through... - Correct answer proper preparations According to the Nuremberg Code (1947), experiments should only be conducted by... - Correct answer scientifically qualified investigators According to the Nuremberg Code (1947), subjects should always be at liberty to... - Correct answer withdraw from experiments According to the Nuremberg Code (1947), investigators must be ready to end an experiment at any stage if... - Correct answer there is cause to believe that continuing the experiment is likely to result in injury, disability, or death to the subject The Declaration of Helsinki (1964) emphasized what? - Correct answer Brought about by the need for human research as opposed to human experimentation and better defined the criteria for consent What organization originally adopted the Declaration of Helsinki? - Correct answer The World Medical Association General Assembly What did the Declaration of Helsinki (1964) provide recommendations for? - Correct answer Recommendations guiding physicians in biomedical research involving human subjects The Declaration of Helsinki (1964) reiterated the basic ethical principles from what document? - Correct answer The Nuremberg Code According to the Declaration of Helsinki (1964), informed consent must be obtained from who? - Correct answer The subject or legal guardian According to the Declaration of Helsinki (1964), design and performance of experimental procedure must be... - Correct answer formulated in a clear protocol According to the Declaration of Helsinki (1964), research protocols should be transmitted to... - Correct answer a specially appointed independent committee for consideration, comment and guidance According to the Belmont Report (1979), justice implies... - Correct answer fairness and is manifested in equitable selection of subjects for research According to the Belmont Report (1979), justice means that selection of subjects for research should be based on... - Correct answer reasons directly related to the problem being studied, not systematic selection of a class of individuals due to compromised position, manipulability, etc. What does the Belmont Report (1979) say about who should receive benefits of research? - Correct answer Benefits should not be restricted to those who can afford it, and research should not involve persons from groups not likely to benefit from application of the research What did the Henry K Beecher Paper reveal - Correct answer 22 published medical studies where patients had been experimented on with no expected benefit to them, showing that unethical studies were widespread and represented a systemic problem in medical research rather than exceptions Human Radiation Experiments (1945-1957) - Correct answer The Atomic Energy Commission conducted secret and classified radiation experiments and releases on unknowning Americans to assess how the human body metabolizes radioactive material. What are the three foundations ethical research as outlined the Belmont Report (1979)? - Correct answer 1. Respect for persons 2. Beneficence 3. Justice Wichita Jury Study (1953) - Correct answer Social scientists covertly recorded discussions of 6 Wichita federal district court civil juries, without the consent of the jurors. Willowbrook Hepatitis Study (1955) - Correct answer Gave children with mental retardation hepatitis in order to track the progression of the disease and to test treatments Milgram's Obedience Study (1963) - Correct answer study of the phenomenon of obedience to an authority figure, examinfed the effects of punishment on learning (shock treatment for mistakes, 65% shocked dangerous amounts when ordered Jewish Hospital Cancer Study (1963) - Correct answer Elderly hospitalized patients were injected with live cancer cells to study the mechanism of immune reaction without true informed consent. Tearoom Trade Study (1970) - Correct answer Analysis of male-male sexual behavior in public toilets by Laud Humphreys. He observed acts masquerading as a voyeur rather than a researcher, tracked participants without their consent by using their license plate numbers, and interviewed them in disguise without disclosing his true intent (research) Stanford Prison Experiment (1970) - Correct answer Volunteers in a mock prison took on the roles of guards and inmates. The experiment was discontinued due to ongoing physical and psychological abuse inflicted on many prisoners. San Antonio Contraceptive Study (1971) - Correct answer Poor Mexican- American women given placebos instead of contraceptives without knowing they were subject to such research. There were high numbers of unplanned pregnancy in the placebo group University of Rochester Death of Healthy Subject (1996) - Correct answer Student dies of heart attack after undergoing lung procedure (bronchoscopy) in study on smoking and air pollution Death in a Gene Transfer Trial (1999) - Correct answer 18 year old volunteer was injected with adenoviral vector carrying a corrected gene to test the safety of the procedure and died four days later despite not being ill prior. PI on the study had a conflict of interest and animal data regarding risks given patient's underlying liver issues was not considered. IRB approved consent form was not used. Johns Hopkins Death of Healthy Subject in an Asthma Study (2001) - Correct answer Inhaled hexamethonium, used to treat high BP in the 50s and 60s and designed to promote a mild asthma attack. Federal investigation found that IRB did not take proper precautions or follow federal regulations, leading to suspension of research. Also issues with pressure on employees to participate in research. What is ICH? - Correct answer The International Conference on Harmonization of Technical Requirements for the registration of pharmaceuticals for human use What is the purpose of the International Conference on Harmonization (ICH)? - Correct answer An attempt to streamline the process for developing and marketing new drugs internationally What is Good Clinical Practice (GCP)? - Correct answer An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects What does compliance with Good Clinical Practice (GCP) provide assurance of? - Correct answer That the rights, safety, and well-being of trial subjects are protected consistent with the principles of the Declaration of Helsinki, and that clinical trial data are credible The ICH GCP guideline provides a unified standard for what countries and why? - Correct answer For the European Union (EU), Japan, and the US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions The guideline for Good Clinical Practice (GCP) was developed with consideration of the current good clinical practices of what countries? - Correct answer The EU, Japan, US, as well as Australia, Canada, the Nordic countries, and the World Health Organization When generating clinical trial data that are intended to be submitted to regulatory authorities, what guideline should be followed? - Correct answer The guideline for good clinical practice The principles established in GCP may also be applied to what? - Correct answer Other clinical investigations that may have an impact on the safety and well-being of human subjects What are the categories of International Committee on Harmonization (ICH)? - Correct answer Quality guidelines Efficacy guidelines Safety guidelines 45 CFR 46 refers to what? - Correct answer Protection of Human Subjects What does 45 CFR 46 outline? - Correct answer Regulations set forth by the U.S. Department of Health and Human Services. HHS regulations apply to research involving human subjects conduced or funded in whole or in part by HHS 21 CFR 50 refers to what - Correct answer Protection of Human Subjects, as set forth by the FDA 21 CFR 56 refers to what - Correct answer Institutional Review Boards, as set forth by the FDA FDA regulations apply to all clinical investigations regulated by the FDA under sections... - Correct answer 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including floods, dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products 45 CFR 46 Subpart A - Correct answer Basic HHS Policy for Protection of Human Research Subjects, also called the Common Rule. Describes the required protections for all human subjects 45 CFR 46 Subpart B - Correct answer Additional protections for pregnant women, human fetuses, and neonates involved in research 45 CFR 46 Subpart C - Correct answer Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects 45 CFR 46 Subpart D - Correct answer Additional protections for children involved as subjects of research 45 CFR 46 Subpart E - Correct answer Registration of Institutional Review Boards 21 CFR 50 - Correct answer Protection of Human Subjects 21 CFR 50 Subpart A - Correct answer General Provisions for the Protection of Human Subjects 21 CFR 50 Subpart B - Correct answer Informed Consent of Human Subjects 21 CFR 50 Subpart C - Correct answer Reserved 21 CFR 50 Subpart D - Correct answer Additional Safeguards for Children in Clinical Investigations 21 CFR 56 - Correct answer Institutional Review Boards 21 CFR 56 - Correct answer IRB general provisions 21 CFR 56 Subpart B - Correct answer IRB organization and personnel 21 CFR 56 Subpart C - Correct answer IRB functions and operations 21 CFR 56 Subpart D - Correct answer Records and Reports 21 CFR 56 Subpart E - Correct answer Administrative Actions for Noncompliance Are there exemptions to 45 CFR 46.101? - Correct answer Exemptions do not apply to research involving prisoners, subpart C. Exemption for research involving survey or interview procedures or observation of public behavior does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigators do not participate in the activities being observed What are the exemptions from IRB requirement (21 CFR 56.104)? - Correct answer Any investigation that commenced before July 27, 1981 Emergency use of a test article Taste and food quality evaluations and consumer acceptance studies Emergency use of a test article is exempt from 21 CFR 56.104 (IRB requirement) provided that.... - Correct answer Such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review What is a legally authorized representative? - Correct answer An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure involved in the research What does minimal risk mean? - Correct answer The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves that those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests According to 45 CFR 46.102, research means... - Correct answer a systemic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge According to 21 CFR 50.3c, clinical investigation means... - Correct answer Any experiment that involves a test article and one or more human subjects and that their is subject to requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit How does 45 CFR 46.102 define a human subject? - Correct answer A living individual about whom an investigator (professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information How does 21 CFR 50.3g define a human subject? - Correct answer An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be a healthy human or a patient How does 45 CFR 46.102 define an IRB? - Correct answer An institutional review board established in accord with and for the purposes expressed in this policy According to 45 CFR 46.107 and 21 CFR 56.107, the IRB should be able to ascertain what? - Correct answer The acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice According to 45 CFR 46.107 and 21 CFR 56.107, who should be included in an IRB that regularly reviews research involving vulnerable subjects (children, prisoners, pregnant women, handicapped/mentally disabled persons)? - Correct answer Individuals who are knowledgeable about and experience in working with these subjects According to 45 CFR 46.108 and 21 CFR 56.108, each IRB should follow... - Correct answer written procedures According to 45 CFR 46.108 and 21 CFR 56.108, what conditions must be met at convened meetings - Correct answer Majority of members are present, including at least one member whose primary concerns are in nonscientific areas. For research to be approved, it shall receive approval of a majority of those members present. The exception is when an expedited review procedure is used. According to 45 CFR 46.109 and 21 CFR 56.109, IRB shall review and have the authority to... - Correct answer Approve, require modifications, or disapprove of research activities According to 45 CFR 46.109 and 21 CFR 56.109, the IRB shall require that information given to subjects as part of informed consent is in accordance with... - Correct answer with 46.116 or 50.25 According to 45 CFR 46.109 and 21 CFR 56.109, the IRB may require that information in addition to that specifically mentioned in 46.116 or 50.25 be given to subjects when... - Correct answer in the IRB's judgement the information would meaningfully add to the protection of the rights and welfare of subjects According to 45 CFR 46.109 and 21 CFR 56.109, IRBs should notify investigators and the institution... - Correct answer in writing of its decision to approve, disapprove, or require modifications to the proposed research activity According to 45 CFR 46.109 and 21 CFR 56.109, continuing reviews should be conducted at intervals appropriate to... - Correct answer the degree of risk of the research According to 45 CFR 46.110 and 21 CFR 56.110, the IRB may use an expedited review procedure to review... - Correct answer -research found by the reviewers to involve no more than minimal risk AND/OR -minor changes in previously approved research According to 45 CFR 46.110 and 21 CFR 56.110, expedited review may be carried out by... - Correct answer The IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. Reviewers may exercise all of the authorities of the IRB except that they may not disapprove the research According to 45 CFR 46.111 and 21 CFR 56.111, the IRB must determine that all of the following requirements are satisfied: - Correct answer -Risks to subjects are minimized -Risks are reasonable in relation to anticipated benefits -Selection of subjects is equitable -Informed consent is sought from each subject or the subject's legally authorized representative -Informed consent is appropriately documented -When appropriate data collected is monitored to ensure subject safety -When appropriate provisions are in place to protect the privacy and confidentiality of subjects -There are additional safeguards for vulnerable populations According to 45 CRF 46.112 and 21 CFR 56.112, research approved by the IRB may be subject to further appropriate review and approval or disapproval by... - Correct answer Officials of the institution According to 45 CFR 46.112 and 21 CFR 56.112, institution officials may not approve research if... - Correct answer it has not been approved by an IRB According to 45 CFR 46.113 and 21 CFR 56, IRB has the authority to suspend or terminate approval of research that... - Correct answer is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects According to 45 CFR 46.113 and 21 CFR 56, any suspension or termination of approval shall... - Correct answer 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 45 CFR 46.116 and 21 CFR 50.25 - Correct answer General requirements for informed consent According to 45 CFR 46.116 and 21 CFR 50.25, what are the general elements for informed consent? - Correct answer -a concise and focused presentation of key information -a statement that the study involves research -purposes of the research -expected duration -procedures -what's considered experimental -risks -benefits -alternatives -confidentiality -who to contact with pertinent questions/injury -how to contact someone independent of the research team -voluntary -no loss of benefits -can discontinue at any time -use in future research -compensation (greater than min risk) -FDA may review -unforeseeable risks as applicable -repro risk -when participation may be terminated -costs -new info may be shared with subject if affecting research -approx number of participants -commercial profit sharing -whether results are disclosed to subject According to the principles of ICH GCP, ____________ are the most important considerations and should prevail over other interests of science and society - Correct answer the rights, safety, and well-being According to the principles of ICH GCP, the available nonclinical and clinical information on an investigational product should be... - Correct answer adequate to support the proposed clinical trial According to the principles of ICH GCP, clinical trials should be scientifically sound and described in... - Correct answer a clear, detailed protocol According to the principles of ICH GCP, a trial should be conducted in compliance with the protocol that has received... - Correct answer prior IRB/ independent ethics committee (IEC) approval/favorable opinion According to the principles of ICH GCP, the medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of... - Correct answer a qualified physician or, when appropriate, a qualified dentist According to the principles of ICH GCP, each individual involved in conducting a trial should be qualified by... - Correct answer education, training, and experience to perform his or her respective tasks According to the principles of ICH GCP, freely given informed consent... - Correct answer Should be obtained from every subject prior to clinical trial participation According to the principles of ICH GCP, all clinical trial information should be recorded, handled, and stored in a way that allows for... - Correct answer accurate reporting, interpretation, and verification According to the principles of ICH GCP, the confidentiality of records that could identify subjects should... - Correct answer be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements According to the principles of ICH GCP, investigational products should be manufactured, handled, and stored in accordance with... - Correct answer applicable good manufacturing practice, and used in accordance with the approved protocol According to the principles of ICH GCP, systems with procedures that assure that assure the quality of every aspect of the trial... - Correct answer should be implemented According to the principles of ICH GCP, the IRB/IEC should obtain what documents? - Correct answer Protocols, amendments, written ICFs, proposed updates, recruitment procedures, written info provided to subjects, IBs, safety info, info about payment and compensation, CVs for investigators According to the principles of ICH GCP, when a non-therapeutic trial is to be carried out with consent of a subjects LAR, the IRB/IEC should... - Correct answer determine that the proposed protocol and/or other documents adequately address relevant ethical concerns and meets applicable regulatory requirements for such trials According to the principles of ICH GCP, the IRB should ensure info regarding payments to subjects is provided in the ICF, including... - Correct answer methods, amounts, and schedule According to the principles of ICH GCP, the language used in consent forms should be... - Correct answer non-technical as is practical and understandable to the subject, LAR, and witness as applicable According to the principles of ICH GCP, the ICF should be signed and dated by - Correct answer The subject/LAR and the person who conducted the informed consent discussion According to the principles of ICH GCP, if a subject or LAR is unable to read... - Correct answer An impartial witness should be present during the entire informed consent discussion to sign the consent form attesting that information was accurately explained and understood, and consent was freely given According to the principles of ICH GCP, a non therapeutic trial is... - Correct answer a trial in which there is no anticipated direct clinical benefit to the subject According to the principles of ICH GCP, when a clinical trial includes subjects who can only be enrolled in the trial with the consent of the subjects LAR, the subject... - Correct answer should be informed about the trial to the extent compatible with the subjects understanding and, if capable, the subject should sign and personally date the written informed consent According to the principles of ICH GCP, non-therapeutic trials may be conducted in subjects with consent of a LAR provided that... - Correct answer -the trial cannot be conducted in subjects who can give consent personally -foreseeable risks are low -negative impact on well-being is minimized and low -the trial is not illegal -IRB approval on inclusion of these subjects What does 21 CFR 11 cover? - Correct answer Electronic records and signatures. It sets for the criteria under which the agency considers electronic records, signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper According to 21 CFR 11.3, biometrics are... - Correct answer a method of verifying an individual's identity based on measurement of the individual's feature(s) or repeatable action(s) where those features and or actions are both unique to that individual and measurable According to 21 CFR 11.3, a closed system is... - Correct answer An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system According to 21 CFR 11.3, electronic records are - Correct answer any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system the investigator has a proprietary interest in the product (patient) or an equity interest in the sponsor of the covered study According to 21 CFR 56, an applicant is defined as... - Correct answer The party who submits a marketing application to the FDA for approval of a drug, device, or biologic product. The applicant is responsible for submitting the appropriate certification and disclosure statements required in this part According to 21 CFR 56, a sponsor of the covered clinical study means... - Correct answer the party supporting a particular study at the time it was carried out According to 21 CFR 56, a clinical investigator means... - Correct answer only a listed or identified investigator of subinvestigator who is directly involved in the treatment or evaluation of research subjects. The term also includes the spouse and each dependent child of the investigator According to 21 CFR 56, compensation affected by the outcome of clinical studies includes... - Correct answer compensation that could be higher for a favorable outcome than for an unfavorable outcome, such that compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest According to 21 CFR 56, significant equity interest in the sponsor of a covered study means... - Correct answer any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (generally, interest in a nonpublicly traded company), or any equity interest in a publicly traded corporation that exceeds $50,000 during the time the clinical investigator is carrying out the study and for 1 year following the completion of the study According to 21 CFR 56, significant payments of other sorts include... - Correct answer payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator that have a monetary value of more that $25,000, exclusive of the costs of conducting the clinical study or other clinical studies (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following the completion of the study According to 21 CFR 56, what are sponsor responsibilities related to financial disclosure? - Correct answer -Collect financial disclosure information from investigators; perform due diligence -Submit summary forms to FDA in marketing applications (3454 and 3455) -Store clinical investigators' financial disclosure info for 2 years after the date of application approval According to 21 CFR 56, what does the sponsor's certification of Form FDA 3454 represent? - Correct answer Attestation to the absence of financial interests and arrangements According to 21 CFR 56, what does the sponsor's disclosure on Form FDA 3454 include? - Correct answer -Any financial arrangement between the sponsor and the clinical investigator where the value of the compensation to the clinical investigator for conducting the study could be influenced by the outcome of the study -any significant payments of other sorts from the sponsor, such as a grant to fund ongoing research, compensation in the form of equipment, retainer for ongoing consultation, or honoraria -Any proprietary interest in the tested product held by any clinical investigator -any significant equity interest in the sponsor held by any clinical investigator -any steps taken to minimize potential bias resulting from any of the disclosed arrangements, interests, or payments According to 21 CFR 56, what responsibility does the clinical investigator have? - Correct answer Clinical investigators subject to investigational new drug or investigational device exemption regulations must provide the sponsor of the study with sufficient accurate information needed to allow subsequent disclosure or certification. They must promptly update this information if any relevant changes occur in the course of the investigation or for 1 year following the completion of the study. What is Form FDA 1572? - Correct answer The statement of investigator What does the investigator commit to by signing Form FDA 1572? - Correct answer -to conduct the study in accordance with the relevant current protocols, and only make changes after notifying the sponsor except when necessary to protect the safety, rights, or welfare of subjects -to personally conduct or supervise the investigation -to inform any patients that drugs are investigational -to ensure the requirements related to informed consent in 321 CFR Par 50 and IRB approval in 21 CFR 56 are met -to report AEs in accordance with 21 CFR 312.64 and understand the IB risks and side effects -to ensure all people involved in study contact are informed on their obligations in meeting the above commitments -to maintain adequate an accurate records in accordance with 31 CFR 312.62 and make those available for inspection in accordance with 21 CFR 312.68 -to ensure IRB complies with 21 CFR 56, initial and continuing review, to promptly report to IRB changes and UPIRTSOs, and not make changes without IRB approval except to eliminate immediate hazards to subjects -comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR 312 According to ICH GCP E6.7, what are investigator brochures? - Correct answer A compilation of clinical and nonclinical data on the investigational product According to ICH GCP E6.7, what purpose does the IB serve to investigators? - Correct answer To provide information that facilitates their understanding of the rationale and compliance with key features of the protocol (dosing, administration, safety monitoring). To provide insight to support clinical management of study subjects. According to ICH GCP E6.7, how must IBs be updated? - Correct answer IBs should be reviewed at least annually, revised in compliance with sponsor's written procedures, and relevant new information should be communicated to investigators, IRBs, and regulatory authorities prior to revision. Sponsors should ensure investigators have the current IB, and investigators are responsible for submission to the IRB. under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than the individual. According to 21 CRF 312.3, a contract research organization (CRO) is... - Correct answer A person that assumes, as an independent contractor with the sponsor, one or more of the obligations of the sponsor, e.g. design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the FDA According to 21 CRF 312.6, how are investigational new drugs to be labeled? - Correct answer "Caution: new drug-limited by federal or US law to investigational use." It must not bear any statement that is false or misleading, particularly that the new drug is safe or effective for the purposes for which it is being investigated According to 21 CRF 312.7, what regulations are there about the promotion of investigational drugs? - Correct answer A sponsor or investigator shall not represent in a promotional context that the drug is safe or effective to preclude commercialization before approval. According to 21 CRF 312.7, can a sponsor commercially distribute or test market investigational new drugs? - Correct answer No According to 21 CRF 312.7, a sponsor shall not unduly prolong an investigation after finding that the results... - Correct answer appear to establish sufficient data to support a marketing application According to 21 CRF 312.8, under what circumstances can a sponsor charge for an investigational drug? - Correct answer Not without prior written authorization from FDA, and they may only recover the direct costs of making the investigational drug available According to 21 CFR 312.20, what should a sponsor do if they want to conduct a clinical investigation with an investigational new drug? - Correct answer -a sponsor shall submit an IND to FDA and wait to begin clinical investigation until the IND is in effect According to 21 CFR 312.20, a sponsor should submit a separate IND for any clinical investigation involving an exception from... - Correct answer informed consent under 21 CFR 20.54 According to 21 CRF 312.30, new protocols may be submitted and changes in previously submitted protocols may be made if... - Correct answer -there is a new protocol -changes in a protocol (phase 1- significantly affects safety, phase 2-3- significantly affects safety, scope of investigation, or scientific quality) -new investigator According to 21 CFR 312.31, what essential information on the IND requiring amendments is not within the scope of the protocol amendment, IND safety reports, or annual reports? - Correct answer -New toxicology, chemistry, or other technical information -Discontinuance of a clinical investigation According to 21 CFR 312.33, how long does a sponsor have to submit a brief annual report on the progress of the investigation? - Correct answer 60 days According to 31 CFR 312.38, the withdrawal of an IND requires... - Correct answer FDA notification, all clinical investigations conducted under the IND ended, all current investigators notified, and all stocks of the drug returned to the sponsor or otherwise disposed of According to 21 CFR 312.40, an IND goes into effect... - Correct answer 30 days after the FDA receives the IND, unless the FDA notifies the sponsor that investigations are subject to a clinical hold. The FDA may notify the sponsor earlier that clinical investigations may commence. According to 21 CFR 312.50, what are the general responsibilities of the sponsor? - Correct answer -to select qualified investigators -provide investigators with information needed to conduct the investigation properly -ensure proper monitoring of the investigation -ensure investigation is conducted in accordance with protocol -maintain an effective IND -ensure FDA and all participating investigators are promptly informed of significant new AEs, risks According to 21 CFR 312.60, what are the general responsibilities of investigators? - Correct answer -ensure the investigation is conducted according to the signed investigator statement, investigational plan, and applicable regulations -protecting the rights, safety, and welfare of subjects -control of drugs under investigation -obtain informed consent of each subject -assure that an IRB that complies with 21 CFR 56 is responsible for initial and continuing review According to 21 CFR 312.21, what phase represents the introduction of an investigational new drug into humans? - Correct answer Phase 1 According to 21 CFR 312.21, what kind of research subjects are used in Phase 1 trials? - Correct answer Normal volunteers or patients According to 21 CFR 312.21, what is the goal of Phase 1 trials? - Correct answer To determine metabolism and pharmacologic actions in humans, side effects with increasing doses, and early evidence of effectiveness According to 21 CFR 312.21, what phase of study is often conducted inpatient and why? - Correct answer Phase 1, to allow to close monitoring According to 21 CFR 312.21, how many subjects are involved in Phase 1 studies? - Correct answer A small number (20-80) According to 21 CFR 312.21, what is the goal of a Phase II trial? - Correct answer A well controlled clinical study to evaluate the effectiveness of a drug for a particular indication and determine short-term side effects and risks According to 21 CFR 312.21, how many subjects are involved in a phase II trial? - Correct answer A relatively small number, usually no more than several hundred According to 21 CFR 312.21, what is the purpose of phase III trials? - Correct answer Expanded controlled and uncontrolled studies intended to gather additional information about effectiveness and safety. They evaluate and special controls alone cannot reasonable assure their safety and effectiveness What are examples of Class III devices? - Correct answer Pacemakers, implanted weight loss devices, non-invasive glucose testing devices, medical imaging analyzers, cochlear implants, breast implants What is the scope of 21 CRF 812? - Correct answer To provide procedures for the conduct of clinical investigations of devices. According to 21 CFR 812.1, what does an approved investigational device exemption allow? - Correct answer A device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device How does 21 CFR 812.3 define a transitional device? - Correct answer A device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976 How does 21 CFR 812.3 define a custom device? - Correct answer A device intending for use by an individual patient named in the order of a physician or dentist, and is to be made in specific form for that patient How does 21 CFR 812.3 define an implant? - Correct answer A device that is placed into a surgically or naturally formed cavity of the body if it is intended to remain there for a period of 30 days or more (shorter duration up to FDA discretion) How does 21 CFR 812.3 define noninvasive as applied to a diagnostic device or procedure? - Correct answer 1. Does not penetrate or pierce the skin or mucous membranes of the body, ocular cavity, or the urethra 2. Does not enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os What does 21 CFR 812.2 apply to? - Correct answer All clinical investigations of devices to determine safety and effectiveness, including IDE- significant risk devices and abbreviated requirements for nonsignificant risk devices. It does not apply to exempted investigations. What kind of device requires FDA and IRB approval? - Correct answer A significant risk device, which is is IDE What qualifies as a significant risk device that requires FDA and IRB approval- IDE? - Correct answer 1. intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject 2. purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject -is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject or -otherwise poses a potential for serious risk to the health, safety, or welfare of a subject What qualifies as a nonsignificant risk (NSR) device? - Correct answer A device that does not meet the definition for a significant risk device Who makes the initial determination of significant risk or nonsignificant risk? - Correct answer The sponsor, followed by the IRB. The FDA is available to help in making the risk determination. An investigation of a device other than a significant risk device is considered to have approved applications for IDE's, unless... - Correct answer FDA has notified the sponsor that approval of an application is required, if the device is is not a banned device, and the sponsor -labels the device in accordance with 812.5 -obtains IRB approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device and maintains such approval -ensures that each investigator participating in an investigation of the device obtains informed consent Abbreviated IDE requirements include that the sponsor - Correct answer - complies with monitoring requirements -maintains required records -follows reporting requirements -ensures that participating investigators maintain the required records and follow reporting requirements -complies with the prohibitions against promotion and other practices What are the reporting requirements according to 21 CFR 812.150? - Correct answer The sponsor reports significant risk device determinations. If an IRB determines that a device is a significant risk device and the sponsor has proposed that the IRB consider the device not to be a significant risk device, the sponsor shall submit to FDA a report of the IRB's determination within 5 working days According to 21 CFR 812.2 (c), what are exempted investigations? - Correct answer 1. A device, other than a transitional device, in distribution before May 28, 1976, which used according to labeling 2. A device other than a transitional device in distribution after May 28, 1976 that the FDA has determined to be substantially equivalent to a device in commercial distribution before May 28, 1976, when used according to labeling 3. A diagnostic device, if the sponsor complies with applicable requirements 4. A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution if the testing is not for the purpose of determining safety or effectiveness and does not put the subject at risk 5. A device intended solely for veterinary use 6. A device shipped solely for research on or with lab animals and labeled accordingly 7. A custom device unless being used to determine safety or effectiveness for commercial distribution What are the applicable requirements for exempted diagnostic device investigations according to 21 CFR 812.2 (c)? - Correct answer - noninvasive -does not require an invasive sampling procedure that presents significant risk -does not by design or intention introduce energy into a subject -is not used as a diagnostic procedure without confirmation by another medically established product or procedure