key concepts in research ethics

Question 1

what is human subject research ?

Answer 1

a research involving living individuals about whom the researcher obtains

Question 2

hippocratic oath and ethics

Answer 2

hippocratic oath alone is not enough to protect human welfare

Question 3

what are the fundamental ethical principles that were included in the Belmont report ?

Answer 3

1. respect for persons (Autonomy)
2. beneficence/Maleficence
3. Justice

Question 4

how is respect for persons achieved ?

Answer 4

obtaining informed consent from potential study participants

Question 5

what are the two rules that have been extracted from beneficence ?

Answer 5

do no harm

maximize possible benefits and minimize possible harms

Question 6

who are considered vulnerable populations ?

Answer 6

pregnant women/fetuses 
children 
elderly 
individuals with poor or no education 
orphans 
prisoners

Question 7

what are the 7 requirements that need to be fulfilled for a research to be ethical ?

Answer 7

1. scientific validity
2. social value
3. community partnership
4. favorable risk-benefit ratio
5. fair subject selection
6. informed consent
7. independent review

Question 8

what are the requirements for informed consent ?

Answer 8

1. disclosure of adequate
   information to the subject
   2.understanding by the subject
2. voluntariness of the decision , no coercion involved

Question 9

what is coercion ?

Answer 9

when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance

Question 10

what is undue inducement ?

Answer 10

occurs through an offer of an excessive inappropriate reward inn order to obtain compliance

Question 11

what are the types of consent ?

Answer 11

1. written informed consent
2. oral informed consent
3. written guardian consent document
4. assent from those under 18 years of age even if the parents agree

Question 12

what is the purpose of independent review ?

Answer 12

minimizes the conflict between funding agents, promotions and protection of subjects

Question 13

who is responsible to ensure that research ethics are in place ?

Answer 13

• institutional review board IEC
• research ethics board REB
• research ethical committee REC
  all the same thing
  which is ann independent committee

Question 14

what is the primary purpose of a REC ?

Answer 14

to assure protection of the rights and welfare of human subjects as research participants

Question 15

what are the components of an ethics review board ?

Answer 15

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

Question 16

what are the three levels of IRB review ?

Answer 16

full board
expedited
exempt

Question 17

when is a full board IRB review required ?

Answer 17

1. when the subjects in question are from a vulnerable group
2. when there is invasive techniques involved in the study
3. involves more than minimal risk

Question 18

when is an expedited IRB review made ?

Answer 18

1. when there is only minimal risk such as in surveys of non sensitive topics
2. these studies require a sub-set of the IRB

Question 19

when is a research exempt from continuing review ?

Answer 19

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

Question 20

how are the levels of IRB determined ?

Answer 20

by the nature of the protocol
level of potential risk
the subject population

Question 21

what is research misconduct ?

Answer 21

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

Question 22

what is fabrication ?

Answer 22

making up data or results and recording or reporting them

ie inventing non-existent data

Question 23

examples of fabrication ?

Answer 23

filling in missing data

recording data of participants who have already died

Question 24

what is falsification ?

Answer 24

manipulating already existing data

Question 25

what is plagiarism ?

Answer 25

appropriation of another person’s idea, processes, results or word without giving appropriate credit