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Ethics and Responsibilities of Research > Midterm > Flashcards

Midterm Flashcards

1
Q

4 Types of Codes for Ethical Research

A
  1. Professional Codes
  2. Government Regulations
  3. Institutional Policies
  4. Personal Convictions
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2
Q

Shared Values for Conduct of Research

A
  1. Honesty
  2. Accuracy
  3. Efficiency
  4. Objectivity
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3
Q

Objectivity

A

letting the facts speak for
themselves and avoiding
improper bias.

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4
Q

Efficiency

A

using resources wisely and

avoiding waste

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5
Q

Accuracy

A

reporting findings precisely
and taking care to avoid
errors

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6
Q

Honesty

A

conveying information
truthfully and honoring
commitments

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7
Q

Research misconduct definition

A

“fabrication, falsification, or plagiarism in proposing,
performing, or reviewing research, or in reporting research
results”
Fabrication: making up results and recording or reporting them
Falsification: manipulation of research materials, equipment, or processes, or changing or omitting results such that the research is not accurately represented in the record.
Plagiarism: the appropriation of another’s ideas, processes, results, or words without giving proper credit.

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8
Q

Criteria for Research Misconduct

A
  1. represent a “significant departure from accepted practices”;
  2. have been “committed intentionally, or knowingly, or
    recklessly”; and
  3. be “proven by a preponderance of evidence.”
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9
Q

UNL Research Misconduct Policies

A

Defined by federal policies
Allegations reported to and assessed by RIO
RIO review allegations, sequesters records and forwards to inquiry committee
Inquiry report goes to investigation committee along with files
Institution and administrative action

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10
Q

Reporting Research Misconduct

A
  1. Seek guidance before making allegations
  2. Clearly document who did what and when they did it
  3. Review institutional procedures
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11
Q

Consequences of Research Misconduct

A
  1. Withdrawal or correction of publications
  2. Reprimand, removal from project, rank and salary reduction, dismissal
  3. Restitution of funds to granting agency
  4. Ineligibility to apply for Federal grants for years
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12
Q

3 Aspects of Nuremburg Code 1947

A
  1. Autonomy: voluntary informed consent
  2. Beneficence: good science and favorable benefit to risk ratio
  3. Justice: equal opportunity to participate and to not participate
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13
Q

Belmont Report

A

Provides boundaries between practice and research
Basic ethical principles: 1) respect for persons, 2) beneficence and 3) justice
Applications: informed consent, assessment of risk and benefits and selection of subjects

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14
Q

45 CFR 46

A 
Subpart A: The Common Rule
B: Pregnant women, human fetuses and neonates
C: Prisoners
D: Children
E: IRB Registration
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15
Q

Assurance of compliance

A

Written commitment to comply with regulations of 45 CFR 46

Approved by Office of Human Research Protection

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16
Q

Exempt from Human Subjects Research

A
  1. Normal educational practices
  2. Educational tests, survey, interviews or observation of public behavior
  3. Elected officials or candidates
  4. Publicly available or anonymous previously existing data
  5. Projects that are conduct by or approved by department or agency head
  6. Consumer tests
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17
Q

IRB

A

Institutional Review Board

Committee charged with review of human subject research to ensure subjects are adequately protected

18
Q

Informed Consent

A

Written Consent: Purpose, procedures, benefits, risks and/or discomforts, compensation, opportunity to ask questions, freedom to withdraw, consent, right to receive a copy, participant feedback survey, and signature of participant

19
Q

Criteria for IRB Approval

A
  1. Risk to subjects are minimized
  2. Risks balanced rewards
  3. Selection is fair
  4. Informed consent is sought
  5. Informed consent is documented
  6. Provisions for monitoring data and safety
  7. Protect privacy of subjects
20
Q

Research Definition

A

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

21
Q

Human Subject Definition

A

A living individual about whom an investigator (whether professional or student) conducting research obtains:

(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.

22
Q

How can informed consent be coercive?

A
  1. Subjects are in a group when recruited and there is an unspoken expectation that they should participate because of their membership
  2. Investigator has position of socioeconomic status or expertise
  3. Technical jargon confuses or intimidates subjects
23
Q

The Three Rs

A
  1. Replacement
  2. Reduction
  3. Refinement
24
Q

US Government Principles of Animal Research

A

Office and Laboratory Animal Welfare
USDA
PHS
Require adherence to the Guide for the Care and Use of Laboratory Animals and the American Veterinary Medical Association Guidelines on Euthanasia

25
Q

Institutional Official

A

Legally responsible for compliance with federal animal welfare regulations

26
Q

Attending Veterinarian

A

Responsible for the health and medical treatment of all animals at an organization’s facilities

27
Q

IACUC

A

Institutional Animal Care and Use Committee
Review research proposals Review animal care programs
Inspect at least 2x a year facilities
Receive and review concerns
Submit reports to Institutional Official

28
Q

Criteria for IACUC approval

A
  1. Selection and justification of species
  2. Living conditions of the animals
  3. Justification for the use of animals
  4. Application of the three Rs
  5. Treatment of pain and discomfort
  6. Use of restraints
  7. Euthanasia methods
  8. Qualification of research personnel
  9. Occupational health and safety
29
Q

Researcher’s Responsibility for Animal Welfare

A
  1. Design and prepare research plan
  2. Submit Protocol for Animal Research Activities to the IACUC
  3. Oversight of housing, feeding and non-medical care of animals
  4. Appropriate euthanasia and disposal of animals
  5. Training of students
  6. Reporting changes to IACUC
30
Q

Reporting non-compliance with animal welfare regulations

A
  1. Attending Vet
  2. IACUC chair
  3. IACUC staff member
  4. Mentor
  5. IO
  6. Ombudsman
31
Q

Conflict of Interest Definition

A

Any financial or other interest which conflicts with the service of the individual because it (1) could significantly impair the individual’s objectivity or (2) could create an unfair competitive advantage for any person or organization.

32
Q

Financial Conflict of Interest

A
  1. A significant financial interest (SFA) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
  2. Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
  3. Examples: stock ownership in a public or private company; receipt of payment for services including consulting work; receipt of intellectual property rights or royalties.
33
Q

Significant Financial Interest Types

A
  1. Income greater than $5,000
  2. Stock worth more than $5,000
  3. Stock and income greater than $5,000
  4. Any amount of equity in a non-publicly traded entity
  5. Income related to intellectual property rights
  6. Reimbursed or sponsored travel
34
Q

Conflicts of Commitment

A

Conflicts of effort or obligation

A situation that places competing demands on researchers’ time and loyalties

35
Q

Personal Conflict of Interest

A
  1. Conflict of conscience, personal beliefs interfere with job
  2. Intellectual conflict: strong personal views on important of research impair ability to perform job
  3. Relationships: i.e. grant proposal or manuscript review
36
Q

Strategies for Managing COIs

A
  1. Require disclose of all interests
  2. Monitor research or check results
  3. Modify research plan
  4. Divestiture of significant financial interests
  5. Remove person with conflict from crucial steps in research process
37
Q

Researcher’s Responsibilities for COIs

A
  1. Become familiar with revised regulations and institutional COI policies
  2. Disclose SFIs to institution annuals and within 30 days of acquiring new SFI
  3. Comply with management plan issued by institution and retain compliance documents
  4. Complete COI training at required intervals (4 years)
38
Q

NSF Data Management Guidelines

A
  1. Policies for re-use, re-distribution, and creation of derivatives; plans for archiving data, samples, and other research outcomes, maintaining access
  2. Types of data, samples, physical collections, software generated; Standards for data and metadata format and content
  3. Access and sharing policies, with stipulations for privacy, confidentiality, security, intellectual property, or other rights or requirements
39
Q

Data ownership

A

Funders: institutions can use data collected with public funds
Private companies retain rights to data
Philanthropic organizations retain or give away ownership
Research institutions claim ownership rights so they can meet responsibilities for data management

40
Q

Data collection

A 
Appropriate methods
Attention to details
Need to be authorized
Two rules:
1. Hard copy evidence
2. Electronic evidence should be validated
41
Q

Data protection

A

Privacy and confidentiality

Data storage: computer backups must be safe, samples must be stored properly, reduce risk of catastrophic events

42
Q

Data sharing

A

Do not have to release preliminary data unless there is a good reason to do so, can withhold until publication
After publication data should be freely available

Ethics and Responsibilities of Research (2 decks)

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