key concepts in research ethics Flashcards
what is human subject research ?
a research involving living individuals about whom the researcher obtains
hippocratic oath and ethics
hippocratic oath alone is not enough to protect human welfare
what are the fundamental ethical principles that were included in the Belmont report ?
- respect for persons (Autonomy)
- beneficence/Maleficence
- Justice
how is respect for persons achieved ?
obtaining informed consent from potential study participants
what are the two rules that have been extracted from beneficence ?
do no harm
maximize possible benefits and minimize possible harms
who are considered vulnerable populations ?
pregnant women/fetuses children elderly individuals with poor or no education orphans prisoners
what are the 7 requirements that need to be fulfilled for a research to be ethical ?
- scientific validity
- social value
- community partnership
- favorable risk-benefit ratio
- fair subject selection
- informed consent
- independent review
what are the requirements for informed consent ?
- disclosure of adequate
information to the subject
2.understanding by the subject - voluntariness of the decision , no coercion involved
what is coercion ?
when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance
what is undue inducement ?
occurs through an offer of an excessive inappropriate reward inn order to obtain compliance
what are the types of consent ?
- written informed consent
- oral informed consent
- written guardian consent document
- assent from those under 18 years of age even if the parents agree
what is the purpose of independent review ?
minimizes the conflict between funding agents, promotions and protection of subjects
who is responsible to ensure that research ethics are in place ?
- institutional review board IEC
- research ethics board REB
- research ethical committee REC
all the same thing
which is ann independent committee
what is the primary purpose of a REC ?
to assure protection of the rights and welfare of human subjects as research participants
what are the components of an ethics review board ?
consists of at least 5 members:
- must include men and women
- must include a community representative
- at least one individual with a scientific background
- must have qualification and experience
what are the three levels of IRB review ?
full board
expedited
exempt
when is a full board IRB review required ?
- when the subjects in question are from a vulnerable group
- when there is invasive techniques involved in the study
- involves more than minimal risk
when is an expedited IRB review made ?
- when there is only minimal risk such as in surveys of non sensitive topics
- these studies require a sub-set of the IRB
when is a research exempt from continuing review ?
these include observations in public settings, reflecting, assisting, anonymous online surveys
these do not require a full IRB review but still need an IRB application form
how are the levels of IRB determined ?
by the nature of the protocol
level of potential risk
the subject population
what is research misconduct ?
fabrication, falsification or plagiarism in proposing, performing, reviewing research or in reporting research results
what is fabrication ?
making up data or results and recording or reporting them
ie inventing non-existent data
examples of fabrication ?
filling in missing data
recording data of participants who have already died
what is falsification ?
manipulating already existing data
what is plagiarism ?
appropriation of another person’s idea, processes, results or word without giving appropriate credit
