Research Exam 1: Set 4

Front 1

Office of Research Integrity

Back 1

The Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration.

Front 2

Acts of Academic Dishonesty (2 Types)

Back 2

Fabrication: creating and/or using made up/altered info in any type of scholarly activity or academic pursuit

Scientific Misconduct: deviation from the standard accepted professional practices in the performance, analysis, reporting, and/or publication of original research

Front 3

Authorship - What Merits?

Back 3

Two of:
conceptualization of data
data collection and assessment
writing of research report

Front 4

Human Research Guidelines (6)

Back 4

Autonomy - pt has right to refuse or choose treatment
Beneficence - practitioner should act in best interest of pt
Non-Maleficence - first, do no harm
Justice - distribution of scarce health resources
Dignity - pt has right to respect & ethical treatment
Truthfulness/Honesty - informed consent, full disclosure

Front 5

Nuremberg Code:
Year
Why
What

Back 5

1947

Code of ethics written in response to criminal experimentation on captive victims performed during WWII

Defined rules and practices for obtaining informed consent and competency of researchers

Front 6

Declaration of Helsinki:
Year
What

Back 6

1964 (rev 1989)
Int'l Code of Ethics for Biomedical Research for development of research proposals

Addressed independent review of protocol by committee not assoc with project

Front 7

Belmont Report:
Year
What

Back 7

1979

Human protection guidelines - ensures protection of human subjects and considered std throughout the US

Front 8

Informed Consent:
Elements

Back 8

Purpose
Procedures
Benefits
Risks & Discomforts
Alternatives to Participation
Confidentiality
Request for More Information
Refusal or Withdrawal
Injury Statement
Consent Statement
Signatures

8th grade language, verbal description, estimate of time, payment info, prorated payment

Front 9

Informed Consent Purpose

Back 9

clear explanation for study & importance, reasons for selecting particular individuals

Front 10

Informed Consent Procedures

Back 10

clear detailed explanation of what will be done to or by subject

Front 11

Informed Consent Benefits

Back 11

potential benefits to subject (if any), to general knowledge, or to future pts or administration of health care

Front 12

Informed Consent Risks & Discomforts

Back 12

truthful & inclusive statements of risks that may result and discomforts that can be expected

Front 13

Informed Consent Alternatives to Participation

Back 13

reasonable alternative procedures maybe used in treatment of individual when treatment intervention is being studied

Front 14

Informed Consent Confidentiality

Back 14

ensure anonymity in collecting, storing, reporting info

Front 15

Informed Consent Request for More Information

Back 15

subject may ask qns about or discuss participation in study at any time

Front 16

Informed Consent Refusal or Withdrawal

Back 16

individual may refuse participation or discontinue participation at any time without prejudice

Front 17

Informed Consent Injury Statement

Back 17

description of measure to be taken if injury occurs as a direct result of the research study

Front 18

Informed Consent Consent Statement

Back 18

confirmation that individual consents to participate in project

Front 19

Informed Consent Signatures

Back 19

participant or guardian (for minors) with assent of minors over age 7 and a witness

Front 20

Institutional Review Board (IRB)
Mission

Back 20

protection of human subjects and compliance with established ethical principles and regulations

Front 21

Multiple Project Assurance

Back 21

assures IRB will review and have approved all research involving human subjects undertaken at UTSW and Childrens, Parkland, Zale, Scottish Rite, Presby Dallas, the VA

Front 22

IRB Review Process Considerations

Back 22

scientific merit
feasibility of study
competence of investigators
subject selection, informed consent, confidentiality
risk to subjects/minimized
risk-benefit ratio

Front 23

Exempt Review

Back 23

research deemed to pose NO RISK to subjects, generally not reviewed by IRB

collection or study of existing data, evaluation of educational programs/outcomes assessment, program evaluation, taste and food quality eval

Front 24

Expedited Review

Back 24

research deemed to pose no more than minimal risk to subjects, generally reviewed by IRB subcommittee

examples: collection of non0invasice specimens, collection of data on non-invasive procedures, moderate exercise/strength test, data for group characteristics or behavior (survey)

Front 25

Full Reivew

Back 25

research deemed to pose more than minimal risk to subjects, generally review by entire IRB

examples: investigational drug/clinical trials, new surgical procedures/devices, children or pregnant, individually identifiable samples