SOCRA CCRP Questions and Answers Already Passed

SOCRA CCRP Questions and Answers Already Passed When was the Nuremberg Code created? 1947 What did the Nuremberg Code establish? Worldwide requirement for informed consent with properly formulated experimentation with beneficence towards participants. When was Belmont report established? 1979 What does the Belmont report do? - Establish boundaries between practice and research - created ethical principles: Respect for persons, Beneficence, and Justice - ensure applications of informed consent, risk/benefit assessment, and selection of research subjects When was the Declaration of Helsinki established? 1964 What is the Declaration of Helsinki? - developed by World Medical Association - provides basic principles for medical research - binds the physician with the words, "The health of my patient will be my first consideration," Which country follows the Declaration of Helsinki? The U.S. What are the 8 required elements of an informed consent? 1. Study description- research acknowledgment, purpose, expected duration, procedures, and specify which procedures are experimental 2. Foreseeable risks and discomforts 3. Benefits 4. Alternative procedures/treatments 5. Confidentiality of records 6. Compensation and treatment for injury 7. Contact information 8. Voluntary participation What education level must an informed consent be written in? 6th-8th grade level What are the additional elements of informed consent? - Risks are unforeseeable - Investigators may terminate participation - Additional costs - Consequences of subject's withdrawal - Significant new findings - Number of subjects participating What are the regulations for informed consent? - Subject must be given adequate time to read prior to signing - Signature of witness/LAR - Signature of person obtaining consent - Date - Signed copy must be given to the subject - Must be current and IRB approved When is a short form ICF needed? For subjects whose first language is not English What are the 10 points of the Nuremberg Code? - Required voluntary, informed consent - Experiment aims at positive results for society - Based on previous knowledge that justifies the experiment - Study design avoids unnecessary physical and mental suffering and injuries - Not conducted if there is any reason to believe it implies a risk of death or disabling injury - Risks < Benefits - Preparations and facilities must be provided to protect subjects against risks - Staff must be fully trained and qualified - Subject must be free to quit at any time - Medical staff stop the experiment at any time if they observe continuation would be dangerous. When can an investigational product be used without a signed consent? - in a life threatening situation - inability to communicate - time is not sufficient - no alternate approved method available that provides an equal or greater likelihood of saving the subject's life When can wards participate in a study? - research related to ward status - conducted in an environment with majority of children are not wards - advocate has best interest of child during research - advocate must not be associated with guardian organization, clinical investigation, or the investigator How long must a Suspected Unexpected Serious Adverse Reaction (SUSAR) be reported to the IRB? </= 15 days How long must an unanticipated adverse device effect (UADE) be reported to the IRB? </= 10 working days How long must an unexpected fatal/life-threatening AE be reported to the IRB? <7 days How long do investigators need to keep current FDFs for? Before study initiation, during the study, and 1 year after study completion What is a significant equity interest amount? > $50,000 What is considered a significant payment made from the sponsor to the investigator? > $25,000 What is the main purpose of the IRB? Assure protection of rights, safety, and welfare of human subjects. Who provides the final approval of a study? a. Sponsor b. FDA c. IRB c. IRB IRB must find when approving a study: - risks are minimized - risks are reasonable for the anticipated benefits - selection of subjects is equitable - ICF follows guidelines - ICF documented appropriately - Adequate provisions for monitoring data collected to ensure the safety of subjects - privacy and confidentiality is protected - additional safeguards in place to protect vulnerable populations - copies of research proposals reviewed - minutes of IRB meetings - records of continuing reviews - copies of correspondence between IRB and investigator - list of IRB members - written procedures for the IRB - statement of significant findings provided to subjects What is documented at IRB meetings? What are significant risk devices? - implants with potential serious risks - used to support or sustain human life - substantial importance in diagnosing, curing, or treating disease What kind of investigational devices are exempt from Premarket approval requirements? (IDE) - diagnostic devices that are non-invasive - for vet or lab use - custom device not intended for commercial distribution - distrubuted prior to May 1976 Who must be part of the IRB members? - males and females - varied background - at least 5 members - 1 scientific background - 1 non-scientific background -1 no institutional affiliation - diverse How long do IRB records (communication with IRB and all approvals) need to be retained? 3 years after study completion What are safeguards for children in clinical investigations? -No greater than minimal risk to children is presented and adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians as set forth in -If it involves greater than minimal risk: (a) The risk is justified by the anticipated benefit to the subjects; (b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians as set forth in What is a sponsor? A person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. Who is responsible for ensuring studies are conducted according to the general investigational plan and protocols in the IND/IDE? Sponsor What must the sponsor do when the sponsor determines that the IP presents an unreasonable and significant risk to study subjects? - discontinue all studies that present the risk - notify fda, all investigators in the studies, and their irbs - assure return and accounting for all IP, return to the sponsor, or on-site destruction Who employs a monitor? CRO or sponsor What does a monitor do? - verify the rights and well-being of subjects are protected - reported data is accurate, complete, and verifiable from source documents - verify study is conducted in compliance with study protocol, GCP guidelines, and applicable regulations Who reports adverse events during the study? The investigator How is an investigator determined to be qualified Education, training, and experience What are a sponsor's responsibilities? Selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. What are an investigator's responsibilities? ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. An investigator shall, in accordance with the provisions of part 50 of this chapter, obtain the informed consent of each human subject to whom the drug is administered, except when a waiver of consent has been given.