Professional Documents
Culture Documents
2020-2021
The Tuskegee Syphilis Study
The Tuskegee Syphilis Study led to the 1979 Belmont
Report and the establishment of the Office for Human
Research Protections (OHRP). It also led to federal laws
and regulations requiring Institutional Review Boards
for the protection of human subjects in studies involving
human subjects.The Office for Human Research
Protections (OHRP) manages this responsibility within
the US Department of Health and Human Services
(HHS).
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Jewish Chronic Disease Hospital Study - 1963
Individuals should be treated Subjects, to the degree that they are capable,
as autonomous agents must be given the opportunity to choose what
shall or shall not happen to them
Persons with diminished autonomy
are entitled to protection. The consent process must include three
elements:
information,
comprehension, and
voluntariness.
Beneficence Assessment of risks and benefits
Human subjects should not be harmed The nature and scope of risks and benefits
must be assessed in a systematic manner
Research should maximize possible
benefits and minimize possible
harms.
The benefits and risks of research There must be fair procedures and outcomes
must be distributed
Dr Basma Damirifairly.
/ Clinical Scientific 20- in the selection of research subjects
The principle of respect
The principle of respect for persons can be broken
down into two basic ideas:
1. Individuals should be treated as autonomous agents
2. Persons with diminished autonomy are entitled to
additional protections
Research Misconduct
• Plagiarism
• Fabrication of data
• Falsification of data
Debarment from receipt of federal
funding
Supervision & certification of
future research
Halt research
Termination
Rescission of degree
Formal reprimand
Formal apology
Ethical training
Suspension / probation
Withholding pay
Definition (continued)
(a) Fabrication is making up data or results and
recording or reporting them.
(b) Falsification is manipulating research materials,
equipment, or processes, or changing or omitting data
or results such that the research is not accurately
represented in the research record.
Editors (ICMJE)
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Good Publication Practices
Avoid misrepresentation in publications
Publish accurate, complete, clear, and unbiased work
Avoid fragmentary publication
Publish manuscripts that represent substantial findings
Stokes, L. Key Issues in Conflict of Interest for Scientific, Engineering, and Educational Research. The Journal of Research
Administration/Theme Issue: Conflict of Interest, v. XXXIII (II), 2002.