Ch 7 - Ethical Issues in Clinical Research

Question 1

Nuremberg Code (1949)

Answer 1

KEY: Individuals should voluntarily consent to participate as a research subject.

Consent ONLY after having sufficient knowledge of the purposes, procedures, inconveniences, and potential hazards of the experiment

Question 2

Declaration of Helsinki (1964)

Answer 2

Last modified in 2013
KEY: Make sure informed consent was obtained from subjects and studies received approval from a review board prior to initiating the research

Question 3

What does the Declaration of Helsinki (1964) address?

Answer 3

The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods

Question 4

National Research Act (1974)

Answer 4

Requires the development of a full research proposal that identifies the IMPORTANCE of the study, OBTAINING informed consent, and REVIEWED by an Institutional Review Board (IRB)

Question 5

Belmont Report (1979)

Answer 5

KEY: Describes the guiding ethical principles for human research studies

Established the RULES and REGULATIONS that govern research efforts of the DHHS and FDA. OHPR is in charge of DHHS, responsible for implementing Belmont report guidelines

Question 6

Practice vs Research

Answer 6

Practice: Routine intervention for the benefit of an individual that has reasonable expectation of success

Research: Activity designed to test a hypothesis, draw conclusions, and contribute to generalize knowledge, which may or may not benefit the individual being studied

Question 7

The Common Rule (1991)

Answer 7

Revised 2 times (2011 and 2019)
Codifies regulations adopted by many federal departments and agencies, with a focus on institutional guidelines, informed consent, and review of proposals for the protection of participants.

Question 8

The Health Insurance Portability and Accountability Act (HIPAA) (1996)

Answer 8

The process of protecting research subjects related specifically to the protection of private health information

Question 9

Guiding Ethical Principles

Answer 9

Respect for Persons
Beneficence
Justice

Question 10

Respect for Persons
~Autonomy~

Answer 10

Personal Autonomy: Self determination and capacity of individuals to make decisions affecting their lives and to act on those decisions

Question 11

Can those with diminished autonomy participate in research?

Answer 11

Those with diminished autonomy must be protected.
IF an authorized surrogate decision-maker is available, and has the ability to make a reasoned decision, and committed to the well-being of the compromised individual

Question 12

Beneficence

Answer 12

Obligation to attend to the well-being of individuals; all who engage in clinical research are bound to MAXIMIZE possible benefits and MINIMIZE possible harm

Question 13

Justice

Answer 13

Fairness in the research process, or the equitable distribution of the benefits and burdens.
Subject selection appropriate for a study; most likely to benefit from its findings

Question 14

Institutional Review Board (IRB)

Answer 14

Federal regulation
Reviews research proposals prior to implementation to ensure that the right of the subjects are protected

Question 15

How many IRB members?

Answer 15

at least 5 with diverse backgrounds that facilitate complete and adequate reviews of the scientific and ethical details proposed research
1 member must be concerned with nonscientific issues such as lawyer, clergyman, or ethicist

Question 16

IRB responsibilities

Answer 16

Review research proposals at convened meeting, considering the scientific MERIT of the project, the COMPETENCE of the investigators, the RISK to subjects, and the FEASIBILITY based on identified resources

Question 17

T/F Proposals with noninvasive procedures or those where subjects can’t be identified do NOT need to go through an IRB review.

Answer 17

False, all proposals for studies involving human subjects must be submitted to the IRB
IRB will determine whether the project qualifies for full review, expedited review, or is exempt.

Question 18

What do researchers need to report during an on-going study?

Answer 18

Any critical incidents associated with the project.
Any changes to the protocol, as they need to be submitted for approval.
Final notification when study is completed

Question 19

Final notification to IRB

Answer 19

Includes information on subjects and study findings

Question 20

Elements of Informed Consent

Answer 20

1. Concise introductory summary
2. Purpose of the research
3. Procedures
4. Potential risks and discomforts
5. Potential benefits
6. Information on study outcomes
7. Alternatives to participation
8. Confidentiality
9. Compensation
10. Contact Information
11. Consent statement
12. Signatures

Question 21

Informed consent process

Answer 21

Starts with an invitation to participate
Statement of purpose of the study permits participants to decide whether they believe in or agree with the worth and importance of the research
The rest of the elements should be presented to them in a comprehendible short format

Question 22

Control groups in an informed consent

Answer 22

Subjects should be aware if the study will have a control group and what that entitles

Question 23

Disclosure -Informed C.

Answer 23

When risks are not great, exemption can be made to the informed consent to prevent bias.
Still have to let subjects know that some information is being withheld and will know at the end of the data collection

Question 24

Potential Risk - Informed C

Answer 24

Steps to be taken to protect against risks and Tx available for potential side effects
Subjects should be notified of any new info. such as identifiable previous unknown risks

Question 25

Potential Benefits -Informed C

Answer 25

researcher should explain the potential application of theoretical findings and how the findings will contribute to future research or patient care and if outcomes of the study will be shared with subjects

Question 26

Subject Information Should Be Confidential and Anonymous

Answer 26

Research subjects should be told that steps are being taken to ensure confidentiality of all information, including descriptive and experimental data

Question 27

The Informed Consent Form Must Be Written in Lay Language

Answer 27

Understanding what they are told or read
Language is clear and basic
Written in lowest educational level

Question 28

The Researcher Must Offer to Answer Questions at Any Time

Answer 28

The subjects should have sufficient time to assimilate the details of the proposed project, prior to making their decision to participate. Question anything they are unsure

Question 29

Consent Must be Voluntary

Answer 29

Subjects participate in own free will
Must be informed that there is no penalty if they refuse
Compensation for participation clear details

Question 30

Subjects Must Be Free to Withdraw Consent at Any Time

Answer 30

Subjects free to discontinue participation at any time (before or during)

Question 31

Research Misconduct

Answer 31

fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results

Question 32

Fabrication

Answer 32

Making up data or results and recording or reporting them

Question 33

Falsification

Answer 33

Manipulation research materials, equipment, or processes, or changing or omitting data or results such that the data are not accurately represented in the research record

Question 34

Plagiarism

Answer 34

Appropriation of another person’s ideas, processes, results, or words w/out giving appropriate credit or attribution, and representing the work as one’s own

Question 35

Conflicts of Interest (COI)

Answer 35

Set of conditions in which professional judgment concerning a primary interest (pts’ welfare) tends to be unduly influenced by a secondary interest (such as financial gain)

Question 36

Purpose of peer reviewed

Answer 36

Provide feedback to an editor who will make decisions about whether a manuscript should be accepted, revised, or rejected

Question 37

Retraction

Answer 37

the retraction of published studies that are found to be fraudulent or containing error