SOCRA Certification Exam 2024: Complete Guide with Verified Answers, Exams of Nursing

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SOCRA CERTIFICATION EXAM 2024 ACTUAL EXAM COMPLETE 200 QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS) ALREADY GRADED A+ Name the 8 elements of INFORMED CONSENT - CORRECT ANSWER >>>>1. statement of research. purpose of research. duration of participation. procedures involved. identification of all that is experimental.

2. Risks and discomforts
3. Benefits
4. Disclosure of alternatives
5. Confidentiality
6. Compensation if injury
7. Who to contact
8. Statement of voluntariness ADDITIONAL: Costs, pregnancy, termination of participation, withdrawal consequences, disclosure of findings, number of subjects in the study.

Clinicaltrials.gov statement. Short Form consent - CORRECT ANSWER >>>>In the context of human subjects research, a written document stating that the elements of informed consent required by the Common Rule have been ORALLY presented to and understood by the subject or the subject's legally authorized representative When can children participate in clinical trials? (conditions) - CORRECT ANSWER >>>>1. No more than minimal risk

2. Adequate assent of the child
3. Risk is justified by potential benefit
4. Risk is above minimal, but likely to yield knowledge about a disorder or condition. Not reasonably different from their expected medical course. Assent. Things to consider when soliciting ASSENT - CORRECT ANSWER >>>>Age, maturity, mental capacity When is ASSENT NOT REQUIRED? - CORRECT ANSWER

Children cannot be reasonably consulted in this case. Benefit is so great. Minimal risk. Could not practicably be carried out without the waiver.

When can WARDS be included? - CORRECT ANSWER

related to their status as wards, conducted in a setting (school) where most are not wards, advocate has experience to act in the best interest of the child (cannot be associated with study team) Within how many days can emergency use of a test article be reported to the IRB? - CORRECT ANSWER 5 Do IRBs need to register with the federal government? - CORRECT ANSWER >>>>Yes! Every IRB that reviews clinical investigations must register under HHS How many members are required to be on an IRB? - CORRECT ANSWER >>>>5 members, with varying backgrounds to promote complete and adequate review of researchj Do the members of an IRB have to represent adequate diversity of backgrounds, race, vulnerability? - CORRECT ANSWER >>>>Yes

1. No more than minimal risk 2. Adequate assent of the child 3. Risk is justified by potential benefit 4. Risk is above minimal, but likely to yield knowledge about a disorder or condition. Not reasonably different from their expected medical course. Assent. Things to consider when soliciting ASSENT - CORRECT ANSWER >>>>Age, maturity, mental capacity When is ASSENT NOT REQUIRED? - CORRECT ANSWER >>>>Children cannot be reasonably consulted in this case. Benefit is so great. Minimal risk. Could not practicably be carried out without the waiver. When can WARDS be included? - CORRECT ANSWER >>>>related to their status as wards, conducted in a setting (school) where most are not wards, advocate has experience to act in the best interest of the child (cannot be associated with study team) Within how many days can emergency use of a test article be reported to the IRB? - CORRECT ANSWER >>>> 5 Do IRBs need to register with the federal government? - CORRECT ANSWER >>>>Yes! Every IRB that reviews clinical investigations must register under HHS How many members are required to be on an IRB? - CORRECT ANSWER >>>>5 members, with varying backgrounds to promote complete and adequate review of researchj Do the members of an IRB have to represent adequate diversity of backgrounds, race, vulnerability? - CORRECT ANSWER >>>>Yes Each IRB shall include atleast 1 _________ and atleast one _______ (3 categories) - CORRECT ANSWER

Scientific member and non scientific member.

Institution affiliated and NON institution affiliated Man and Woman Do a majority of IRB members need to be present when reviewing protocols? - CORRECT ANSWER >>>>I think so. And you definitely need one nonscientific person. Does an IRB have to write out its reasons for not approving an IRB? - CORRECT ANSWER >>>>Yes. It must allow the investigators appropriate response. Does an IRB have to do a yearly continuing review? - CORRECT ANSWER >>>>Review of research at intervals appropriate to the degree of risk, not less than once per year (I suppose this could mean modifications like CHOP) When can an IRB use an expedited review method? - CORRECT ANSWER >>>>Research is no more than minimal risk OR minor changes to previously approved research What criteria must be met for an IRB to approve a study?

• CORRECT ANSWER >>>>-Risks are MINIMIZED
• Risks are reasonable in proportion to benefits
• Selection of subjects is equitable
• Informed consent will be sought

• Informed consent will be appropriately documented
• Data will be monitored for subject safety
• Adequate provisions to protect privacy and confidentiality
• Additional safeguards are in place for vulnerable subjects
• All research is in complianace with FDA part 50, subpart D Can an IRB suspend or terminate research? - CORRECT ANSWER >>>>Yes. If unanticipated harm, or if researchers are not following IRB requirements How long are IRB records required to be maintained after completion of a study? - CORRECT ANSWER >>>>3 years (and accessible!). FDA can shut it down if IRBs are not keeping records appropriately Are there a lot of required documentations and records by the IRB? - CORRECT ANSWER >>>>Yes. Lots of written procedures, must keep copies of meeting minutes, copies of correspondance, research proposals etc. Everything needs to be documented! Does the FDA have the power to shut down, stop studies, etc if an IRB is not operating in compliance? - CORRECT

ANSWER >>>>Yes! Can full on disqualify if they repeatedly dont comply. When does a research drug need an IND? - CORRECT ANSWER >>>>If it can't be legally marketed or shipped, it needs an IND. If you're hoping for a label change or a new indication for use, it needs an IND. When does a research drug NOT need an IND? - CORRECT ANSWER >>>>It is already legally able to be marketed. Your research doesn't aim to change label or current use. If it doesn't increase risk, or go in unstudied populations etc. Do you need an IND for a placebo drug? - CORRECT ANSWER >>>>NO Do you need an IND for a UNLABELED indication of an approved product? - CORRECT ANSWER >>>>No, and this is confusing to me. Do investigational new drugs need to be clearly labeled as such? - CORRECT ANSWER >>>>Yes Can sponsors charge for an investigational drug? - CORRECT ANSWER >>>>Yes, but it has to be regulated

and approved by the FDA. And they need to show proof that its efficacious. Also, the cost of the drug must be burdensome on the sponsor in order for them to charge for it. What are the three phases of investigational drug studies? Describe and provide average # of subjects. - CORRECT ANSWER >>>>Phase 1 - initial introduction of IND into humans. Determine metabolism and pharmacologic actions, pharmacokinetics. 20- 80 subjects. Phase 2 - Controlled clinical study to evaluate effectiveness for a particular indication. Determine short term side effects and risks. Several hundred subjects. Phase 3 - Gather additional information about safety and efficacy, needed to evaluate overall benefit-risk ratio. Hundreds to thousands of subjects. What does an Investigator's Brochure contain? - CORRECT ANSWER >>>>Drug substance, formula, structural formula. summary of animal data, summary of any human data. Pharmacokinetics in animals/humans. Summary of safety and efficacy, risks and side effects (to the extent known)

Is an IND application brief? - CORRECT ANSWER >>>>No it needs a billion and one things, like a grant but way worse. Summarizing the state of the union on this drug across time and nations How does an SAE differ from an AE? - CORRECT ANSWER

SAE contains death, life-threatening state, inpatient hospitalization (or prolongation thereof), incapacity, birth defect. Do researchers need to submit annual reports updating the FDA on their IND? - CORRECT ANSWER >>>>YES! lots of details needed. How soon after an IND is submitted can investigators begin their studies? - CORRECT ANSWER >>>>30 days What is a "clinical hold" in regard to an IND? - CORRECT ANSWER >>>>Issued by the FDA to delay a proposed clinical investigation or to suspend an ongoing investigation. This means no new subjects can be recruited. Why might a clinical hold be issued? - CORRECT ANSWER unreasonable risk is posed to human subjects,

investigators are not qualified, brochure is misleading, IND is not sufficient, reproductive toxicity, etc. OR approved for marketing by another study. OR shown to be ineffective. Can the FDA terminate an IND? - CORRECT ANSWER

Yes, for mostly the same reasons why they would impose a clinical hold Can an IND be deemed "inactive" but not "terminated"? - CORRECT ANSWER >>>>Yes. if no subjects are entered for 2 years or more, or if on clinical hold for 1 year, the No it needs a billion and one things, like a grant but way worse. Summarizing the state of the union on this drug across time and nations How does an SAE differ from an AE? - CORRECT ANSWER >>>>SAE contains death, life-threatening state, inpatient hospitalization (or prolongation thereof), incapacity, birth defect. Do researchers need to submit annual reports updating the FDA on their IND? - CORRECT ANSWER >>>>YES! lots of details needed. How soon after an IND is submitted can investigators begin their studies? - CORRECT ANSWER >>>>30 days What is a "clinical hold" in regard to an IND? - CORRECT ANSWER >>>>Issued by the FDA to delay a proposed clinical investigation or to suspend an ongoing investigation. This means no new subjects can be recruited. Why might a clinical hold be issued? - CORRECT ANSWER >>>>unreasonable risk is posed to human subjects, investigators are not qualified, brochure is misleading, IND is not sufficient, reproductive toxicity, etc. OR approved for marketing by another study. OR shown to be ineffective. Can the FDA terminate an IND? - CORRECT ANSWER >>>>Yes, for mostly the same reasons why they would impose a clinical hold Can an IND be deemed "inactive" but not "terminated"? - CORRECT ANSWER >>>>Yes. if no subjects are entered for 2 years or more, or if on clinical hold for 1 year, the IND can be placed on inactive status. Does the FDA spell out suggested meetings as well as dispute resolution for sponsors and investigators? - CORRECT ANSWER >>>>Yes Who is ultimately responsible for the proper conduct of a study? - CORRECT ANSWER >>>>Sponsor. They select monitors and investigators. Do investigators need to supply sponsors with a whole host of information, kind of like a grant application? - YES! lots of details needed. How soon after an IND is submitted can investigators begin their studies? - CORRECT ANSWER >>>>30 days What is a "clinical hold" in regard to an IND? - CORRECT ANSWER >>>>Issued by the FDA to delay a proposed clinical investigation or to suspend an ongoing investigation. This means no new subjects can be recruited. Why might a clinical hold be issued? - CORRECT ANSWER >>>>unreasonable risk is posed to human subjects, investigators are not qualified, brochure is misleading, IND is not sufficient, reproductive toxicity, etc. OR approved for marketing by another study. OR shown to be ineffective. Can the FDA terminate an IND? - CORRECT ANSWER >>>>Yes, for mostly the same reasons why they would impose a clinical hold Can an IND be deemed "inactive" but not "terminated"? - CORRECT ANSWER >>>>Yes. if no subjects are entered for 2 years or more, or if on clinical hold for 1 year, the IND can be placed on inactive status. Does the FDA spell out suggested meetings as well as dispute resolution for sponsors and investigators? - CORRECT ANSWER >>>>Yes Who is ultimately responsible for the proper conduct of a study? - CORRECT ANSWER >>>>Sponsor. They select monitors and investigators. Do investigators need to supply sponsors with a whole host of information, kind of like a grant application? - CORRECT ANSWER >>>>Yes

Who receives the investigator's brochure? - CORRECT ANSWER >>>>Every participating clinical investigator How long does a sponsor need to keep records after a marketing application for a drug is approved? - CORRECT ANSWER >>>>2 years Can FDA inspect whenever they want? - CORRECT ANSWER >>>>Yes i think so What are the responsibilities of the investigator? - CORRECT ANSWER >>>>Uphold their investigator's agreement and conduct study according to plan. Obtain informed consent. What type of records to investigators need to keep, and for how long after marketing approval? - CORRECT ANSWER >>>>Disposition of drug records, case histories. For 2 years. Who submits annual reports to FDA, the investigator or the sponsor? - CORRECT ANSWER >>>>The sponsor. Who submits reports of SAEs, and to whom? - CORRECT ANSWER >>>>The investigators report to the sponsor, and also to the IRB i think

Can a clinical investigator be disqualified? Why might that be the case? - CORRECT ANSWER >>>>Yes - if repeatedly or deliberately failed to comply with subparts, agreements etc, or falsified any information. Is there a different set of regulations when it comes to life-threatening / debilitating diseases for which no good alternatives exist? - CORRECT ANSWER >>>>Yes, evaluate the risk-benefit ratio differently Can drugs be imported and exported for clinical trials? - CORRECT ANSWER >>>>Yes, under specified circumstances and with proper review etc. Can the FDA "rely" on an "external" FDA in a multi- national trial? - CORRECT ANSWER >>>>Yes - you can accept foreign IND's if they were conducted under GCP etc, if the FDA can validate the data, and also need to submit lots of regulatory stuff. Is an IND application automatically public knowledge? - CORRECT ANSWER >>>>No, it can be if investigator's want it to be.

expanded access - CORRECT ANSWER >>>>The use of an investigational new drug (IND) outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. Requires an application. Can a special access be granted for small patient populations, i.e. orphan drugs, orphan conditions? - CORRECT ANSWER >>>>Yes - special considerations. Do the policies of devices largely mirror the policies for investigational new drugs? - CORRECT ANSWER >>>>Yes, mirrored closely Federal Regulations Part 45/46 - CORRECT ANSWER

Protection of Human Subjects - Protection of Public Welfare Federal Regulations Part 21 - CORRECT ANSWER Electronic Records, Human Subjects (50), IRB, IND, Investigational Devices 04955D - CORRECT ANSWER >>>>auth code smh What types ofhuman subjects research could be considered exempt from human subjects

review/regulation? - CORRECT ANSWER >>>>Schools, educational tests, unidentifiable subjects, benign behavioral interventions, secondary research, public services research, expedited review - CORRECT ANSWER >>>>a review of study proposals that pose minimal risk to subjects; one or two IRB members participate What are requirements for waiver of informed consent? - CORRECT ANSWER >>>>Minimal risk, and could not be practicably be carried out without the waiver When may fetuses or pregnant women be included in research? - CORRECT ANSWER >>>>-pregnant animals and non pregnant people have already been assessed for risk

• risk to fetus/pregnant women is less than direct benefit
• there is minimal risk to woman and fetus
• this biological knowledge can be obtained by no other means If benefit is EXCLUSIVE to the fetus, with no benefit to the pregnant woman, who needs to consent? - CORRECT ANSWER >>>>woman and father (there are exceptions

for rape, artificial insemination, death/disability, and unavailability) If there is no risk/benefit for the fetus, only a potential risk/benefit for mom, who needs to consent? - CORRECT ANSWER >>>>pregnant woman only Are there protections for coerced abortion for research?

• CORRECT ANSWER >>>>Yes. You cannot compensate for a terminated pregnancy.The individuals doing the research cannot determine the viability of pregnancies or timing of terminations. When can nonviable and questionably viable neonates be included in research? - CORRECT ANSWER

preclinical/clinical studies have been conducted.

• researchers have no role in determining viability
• research enhances possibility of survival
• biomedical knowledge cannot be obtained ANY other way If Nonviable neonates are included in research... what are some protections that limit the research that can be done on them? - CORRECT ANSWER >>>>Cannot artificially maintain a heartbeat or vitals
• cannot TERMINATE the heartbeat or respiration/ vitals

• No additional risk to the neonate
• biomedical knowledge cannot be obtained any other way For a nonviable neonate, who needs to consent? - CORRECT ANSWER >>>>Both parents (exceptions for unavailability, rape, incest etc) IRB rules when prison research is involved - CORRECT ANSWER >>>>majority of the IRB members can have no relation to the prisoners. A prisoner or prisoner representative with appropriate background must serve Name some protections against coercion in prison research - CORRECT ANSWER >>>>Cannot affect his/her parole status. Cannot give advantages or compensation that would coerce. Subject selection must be equitable/random. When can research include prisoners? - CORRECT ANSWER >>>>If it is RELEVANT to incarcerated peoples. Does the FDA define the term children in terms of years?
• CORRECT ANSWER >>>>No. A child is someone who

cannot legally consent to treatments or procedures in research (defined locally) Describe some instances when children MAY be included in research. - CORRECT ANSWER >>>>-Minimal risk

• risk is small in comparison to direct anticipated benefit
• NO OTHER WAY of obtaining this information
• appropriate preclinical trials
• yield knowledge about a disease or condition
• adequate assent/consent in place When is assent not needed? - CORRECT ANSWER >>>>- Children are incapacitated/not sound to assent
• Benefit is so great to the child
• minimal risk Are there instances in which both parents need to consent for a child to participate in research? - CORRECT ANSWER >>>>YES. I suppose more than minimal risk? of course, there are exceptions Are there exceptions for parental consent when a child is neglected or abused? - CORRECT ANSWER >>>>Yes When can WARDS be included in research? - CORRECT ANSWER >>>>If the research is directly related to their

status as wards. If they are part of a big group... like a (non-ward) school, where excluded them would be inappropriate What government office do IRBs register under? - CORRECT ANSWER >>>>OHRP (office of human research protections) When an IRB submits appropriate information to OHRP and is registered, how long is their registration active for? - CORRECT ANSWER >>>>3 years FDA Notice Of Inspection (482) - CORRECT ANSWER

An FDA Inspector presents this form which details rights, policies etc when they arrive on-site to Inspect an organization -Minimal risk - risk is small in comparison to direct anticipated benefit - NO OTHER WAY of obtaining this information - appropriate preclinical trials - yield knowledge about a disease or condition - adequate assent/consent in place When is assent not needed? - CORRECT ANSWER >>>>- Children are incapacitated/not sound to assent - Benefit is so great to the child - minimal risk Are there instances in which both parents need to consent for a child to participate in research? - CORRECT ANSWER >>>>YES. I suppose more than minimal risk? of course, there are exceptions Are there exceptions for parental consent when a child is neglected or abused? - CORRECT ANSWER >>>>Yes When can WARDS be included in research? - CORRECT ANSWER >>>>If the research is directly related to their status as wards. If they are part of a big group... like a (non-ward) school, where excluded them would be inappropriate What government office do IRBs register under? - CORRECT ANSWER >>>>OHRP (office of human research protections) When an IRB submits appropriate information to OHRP and is registered, how long is their registration active for? - CORRECT ANSWER >>>>3 years FDA Notice Of Inspection (482) - CORRECT ANSWER >>>>An FDA Inspector presents this form which details rights, policies etc when they arrive on-site to Inspect an organization FDA Inspectional Observations (483) - CORRECT ANSWER Lists (negative) observations during an inspection. A copy has to be given to organization. This form should include recommended corrective action. The action CAN be taken immediately with the inspector. FDA Statement of Investigator (1572) - CORRECT ANSWER >>>>Provided to Sponsor. This is the "Investigator's Agreement" that they will uphold stated

practices and communications and record keeping. The investigator also submits qualification information about themselves. FDA Certification - Financial Interests/Arrangements of Clinical Investigators (3454) - CORRECT ANSWER

This is the form that certifies that investigators have NO financial conflict of interests exist. Certified! FDA Disclosure - Financial Interests/Arrangements of Clinical Investigators (3455) - CORRECT ANSWER >>>>If financial conflicts of interest exist, use this form to DISCLOSE Them! Attach the details of the conflict to this

OHRP (office of human research protections) When an IRB submits appropriate information to OHRP and is registered, how long is their registration active for? - CORRECT ANSWER >>>>3 years FDA Notice Of Inspection (482) - CORRECT ANSWER >>>>An FDA Inspector presents this form which details rights, policies etc when they arrive on-site to Inspect an organization FDA Inspectional Observations (483) - CORRECT ANSWER >>>>Lists (negative) observations during an inspection. A copy has to be given to organization. This form should include recommended corrective action. The action CAN be taken immediately with the inspector. FDA Statement of Investigator (1572) - CORRECT ANSWER >>>>Provided to Sponsor. This is the "Investigator's Agreement" that they will uphold stated practices and communications and record keeping. The investigator also submits qualification information about themselves. FDA Certification - Financial Interests/Arrangements of Clinical Investigators (3454) - CORRECT ANSWER >>>>This is the form that certifies that investigators have NO financial conflict of interests exist. Certified! FDA Disclosure - Financial Interests/Arrangements of Clinical Investigators (3455) - CORRECT ANSWER >>>>If financial conflicts of interest exist, use this form to DISCLOSE Them! Attach the details of the conflict to this form. FDA Voluntary Reporting of AEs and Product Problems (3500) - CORRECT ANSWER >>>>voluntary reporting of Aes, probems, use errors. These are less serious AEs

FDA Mandatory Reporting for use by User-Facilities, Distributors, Manufacturers (3500A) - CORRECT ANSWER

3500A is MANDATORY and includes details of serious AEs that led to death or serious injury Which FDA reporting form can also be used by patients? -

Lists (negative) observations during an inspection. A copy has to be given to organization. This form should include recommended corrective action. The action CAN be taken immediately with the inspector. FDA Statement of Investigator (1572) - CORRECT ANSWER >>>>Provided to Sponsor. This is the "Investigator's Agreement" that they will uphold stated practices and communications and record keeping. The investigator also submits qualification information about themselves. FDA Certification - Financial Interests/Arrangements of Clinical Investigators (3454) - CORRECT ANSWER >>>>This is the form that certifies that investigators have NO financial conflict of interests exist. Certified! FDA Disclosure - Financial Interests/Arrangements of Clinical Investigators (3455) - CORRECT ANSWER >>>>If financial conflicts of interest exist, use this form to DISCLOSE Them! Attach the details of the conflict to this form. FDA Voluntary Reporting of AEs and Product Problems (3500) - CORRECT ANSWER >>>>voluntary reporting of Aes, probems, use errors. These are less serious AEs FDA Mandatory Reporting for use by User-Facilities, Distributors, Manufacturers (3500A) - CORRECT ANSWER >>>>3500A is MANDATORY and includes details of serious AEs that led to death or serious injury Which FDA reporting form can also be used by patients? - CORRECT ANSWER >>>>3500 (not life threatening)

Quick Overview: BELMONT REPORT (year and summary) - CORRECT ANSWER >>>>The Belmont Report is a summary of the agreements about ethics of human research from the Commission that was created by the 1974 National Research Act. These deliberations occurred in 1976. Quick Overview: NUREMBURG CODE - CORRECT ANSWER

A set of 10 ethical principles for human experimentation. Developed in 1947 as a result of trials held in Nuremburg, Germany for medical personnel involved in the Nazi biomedical experimentation/torture/murder in concentration camps. Quick Overview: DECLARATION OF HELSINKI - CORRECT ANSWER >>>>A set of ethical principles for medical research on human subjects originally set forth in 1964. Developed by the WORLD MEDICAL ASSOCIATION If financial conflicts of interest exist, use this form to DISCLOSE Them! Attach the details of the conflict to this form. FDA Voluntary Reporting of AEs and Product Problems (3500) - CORRECT ANSWER >>>>voluntary reporting of Aes, probems, use errors. These are less serious AEs FDA Mandatory Reporting for use by User-Facilities, Distributors, Manufacturers (3500A) - CORRECT ANSWER >>>>3500A is MANDATORY and includes details of serious AEs that led to death or serious injury Which FDA reporting form can also be used by patients? - CORRECT ANSWER >>>>3500 (not life threatening) Quick Overview: BELMONT REPORT (year and summary) - CORRECT ANSWER >>>>The Belmont Report is a summary of the agreements about ethics of human research from the Commission that was created by the 1974 National Research Act. These deliberations occurred in 1976. Quick Overview: NUREMBURG CODE - CORRECT ANSWER >>>>A set of 10 ethical principles for human experimentation. Developed in 1947 as a result of trials held in Nuremburg, Germany for medical personnel involved in the Nazi biomedical experimentation/torture/murder in concentration camps. Quick Overview: DECLARATION OF HELSINKI - CORRECT ANSWER >>>>A set of ethical principles for medical research on human subjects originally set forth in 1964. Developed by the WORLD MEDICAL ASSOCIATION (WMA) Quick Overview: ICH HARMONISED GUIDELINE FOR GCP - CORRECT ANSWER >>>>GCP is international guidelines for conduct of TRIALS. Developed by an international health council in 1990s to harmonize international

guidelines that were already put forth. Meant to faciliate clinical trials internationally, especially between US, EU, Japan, and Switzerland. It serves to both protect subjects AND to assure data quality / good practice. Quick Overview: Paperwork reduction act of 1995 - CORRECT ANSWER >>>>The purpose was to reduce the Burden of paperwork held by the public (or people involved in trials). Basically, before you have people fill out forms... it HAS to be approved by Office of Management and Budget. Why is the Belmont report such named? - CORRECT ANSWER >>>>The Commission created by the National Research Act held its deliberations at the Belmont Conference Center of the Smithsonian. Please name the 3 Broad Sections of the Belmont Report

• CORRECT ANSWER >>>>1. Boundaries between Practice and Research

2. Basic Ethical Principles (there are 3)
3. Applications (there are 3)

What are the 3 basic ethical principles outlined in the belmont report? - CORRECT ANSWER >>>>Respect for Persons, Beneficence, and Justice What are the 3 "Applications" Outlined in the Belmont report? - CORRECT ANSWER >>>>Informed Consent Assessment of Risk and Benefits Selection of Subjects How does the Belmont report distinguish between Practice and Research? - CORRECT ANSWER

Practice: Interventions SOLELY designed to benefit and individual, already have a reasonable expectation of success. Research: an activity to test a hypothesis, develop generalizable knowledge. Formal protocol and procedures defined. respect for persons - CORRECT ANSWER >>>>treating persons as autonomous agents and protecting those with diminished autonomy (relates to children, prisoners, mental disability, respect for peoples opinions and judgements)

Beneficence (Definition) - CORRECT ANSWER

Maximize possible benefits and minimize possible harms. Belmont Report: Justice - CORRECT ANSWER >>>>fair balance between those who participate and those who benefit. (good distribution of BURDENS vs. Benefits) you can't study prisoners to benefit larger society (and other examples) What are the 3 important elements of informed consent, as outlined in the Belmont Report applications? - CORRECT ANSWER >>>>Information, Comprehension, Voluntariness Describe the differences in information, comprehension, voluntariness - CORRECT ANSWER >>>>Information is WHAT is presented. Comprehension is HOW it is presented (time, organization, layman's terms, simple english). Voluntariness is freedom from coercion and influence (like from powerful people/power imbalance/threats) How should selection of subjects be systematically approached? - CORRECT ANSWER >>>>Adults before

children, capable before incapable, free before unfree etc. Free from social, racial cultural biases. Why is the Nuremburg Code such named? - CORRECT ANSWER >>>>Came about from the trials held in Nuremburg Germany to prosecute unethical human experimentation in concentration camps Describe (in brief) the 10 principles set forth by the Nuremburg Code - CORRECT ANSWER >>>>1. Voluntary Consent of the subject

2. Fruitful results unprocurable by other methods
3. Based on animal results and natural history
4. Avoid ALL unnecessary suffering
5. Cannot conduct study in which death or disability will reasonably occur
6. Degree of risk should NEVER outweigh societal benefit
7. Proper preparations and adequate facilities to protect subjects
8. Only conducted by scientifically qualified persons with the highest skill and care
9. Human subjects must be at liberty to bring the experimentation on them to an end
10. Investigator must terminate any experiment when he has probably cause to believe death, injury, or disability is likely

Please order dec of helsinki, belmont report, and nuremburg code in chronological order - CORRECT ANSWER >>>>1. Nuremburg code (40s)

2. Dec of Helsinki (60s)
3. Belmont report (70s) Who is the target audience of the Declaration of Helsinki? - CORRECT ANSWER >>>>Physicians Loosely describe the contents of the declaration of helsinki - CORRECT ANSWER >>>>Contains a lot of information that the other reports have. Principles of consent, investigator qualification, use of placebo, post- trial provisions, honestly kind of all over the place. Protection of vulnerable subjects, etc. Contrast an adverse drug reaction with an adverse event

• CORRECT ANSWER >>>>AEs don't have to be related to the drug/intervention. For ADRs, there is some possibility they are related. Please name the 9 sections of the ICH GCP - CORRECT ANSWER >>>>1. Definitions

2. 10 original Principles of GCP
3. IRB

4. Investigator
5. Sponsor
6. Protocol
7. Investigator's Brochure
8. Essential Documents for clinical trials
9. Paperwork Reduction Act Please name the 10 Principles of GCP (can include amendments) - CORRECT ANSWER >>>>1. Conducted according to Dec of Helsinki ethics
10. Risks must be in proportion to benefit
11. Wellbeing of individual subjects is more important than anything
12. Information (clin and non-clin) on an investigational product must be thorough
13. Scientifically sound protocol
14. Approved by IRB
15. Investigators must be QUALIFIED
16. Every individual involved in a trial must be QUALIFIED
17. CONSENT
18. Accurate reporting, interpretation, and verification of data are crucial
19. Confidentiality protected
20. Good Manufacturing Practice for drugs/devices
21. SYSTEMS in place to assure quality and safety