RESEARCH ETHICS
Module 1: responsibility in research ......................................................................... 8
1.1. What is a good researcher? .......................................................................... 8
1.1.1. Introduction to virtue ethics................................................................... 8
1.1.1.1. Virtue considerations ..................................................................... 8
1.1.1.1.1. Eudaimonia ............................................................................... 8
1.1.1.2. External goods ............................................................................... 9
1.1.2. From virtues to virtuous researchers ...................................................... 9
1.2. Research groups as moral communities ..................................................... 10
1.2.1. The social value requirement ............................................................... 10
1.2.2. The social value of clinical research ..................................................... 11
1.2.3. interview on responsible research and innovation (RRI)......................... 12
Module 2: ethics infrastructure and governance .................................................... 14
2.1. Scandals and abuse in mid 20th century and the resulting guidelines ............ 14
2.1.1. American context and the Belmont report ............................................ 15
2.1.2. Research ethics and law ..................................................................... 17
2.1.2.1. The treaty on the functioning of the European Union (TFEU) ........... 17
2.2. Ethical requirements for research ............................................................... 18
2.2.1. Risk-benefit assessment ..................................................................... 18
2.2.1.1. Assessing and minimizing risks ..................................................... 19
2.2.1.2. Assessing and maximizing the benefits ......................................... 19
2.2.2. Clinical trials: how do they work and what are the ethical requirements? 20
2.2.2.1. Huntington’s disease youth organization (HDYO) ........................... 20
2.2.3. case study: the polyIran trial ................................................................ 21
2.2.4. Randomized controlled trials: what are they and what are the ethical
issues 21
2.2.5. Placebo-controlled trials ..................................................................... 22
2.3. Ethics committees ..................................................................................... 23
2.3.1. Interview with the chair of the SMEC committee a KU Leuven ................ 23
2.3.2. Interview with the chair of research ethics committee UZ/KU Leuven .... 25
2.3.3. Interview with KU Leuven researchers: ethics review............................. 28
, 2.3.4. Interview on international research ethics governance .......................... 30
2.4. Further resources ...................................................................................... 32
2.4.1. Key terms ........................................................................................... 32
2.4.1.1. Risks-benefit assessment ............................................................ 32
2.4.1.2. Clinical trial ................................................................................. 33
2.4.1.3. Randomized controlled trial ......................................................... 33
2.4.1.4. Placebo ....................................................................................... 33
2.4.1.5. Ethics committee......................................................................... 33
Module 3: informed consent: informing participants .............................................. 36
3.1. What is informed consent and why is it important? ...................................... 36
3.1.1. Informed consent and respect for persons ........................................... 37
3.1.2. Interview on informed consent: basing autonomy in dignity................... 42
3.1.2.1. the historical background of the concept of informed consent ....... 42
3.1.2.2. The limitations of autonomy as an ethical justification for doing
research 43
3.1.2.3. his proposal that we use human dignity to justify doing research on
human subjects ............................................................................................ 44
3.1.3. Key aspects of informing participants .................................................. 44
3.2. Deception: a challenge for informed consent .............................................. 46
3.2.1. Milgram’s obedience study .................................................................. 46
3.2.2. Interview on risks, benefits and safeguards of deceptive studies ........... 47
3.2.2.1. The harms and benefits associated to the use of deception in
research 47
3.2.2.2. Possible safeguards and harm mitigation methods and presumed &
retrospective consent .................................................................................... 49
3.3. Understanding ........................................................................................... 51
3.3.1. Informed consent form........................................................................ 51
3.3.2. Understanding of research participants ............................................... 53
3.3.3. The reality of informed consent ............................................................ 54
3.3.4. Readability of informed consent forms ................................................. 54
3.3.4.1. What is readability? ..................................................................... 54
3.3.4.2. How can we measure readability? ................................................ 54
3.3.4.3. What readability score is appropriate for consent forms................. 55
, 3.3.4.4. How to measure the readability of a text? ...................................... 56
3.3.5. Readable: using the SMOG formula ..................................................... 56
3.3.6. eConsent: New developments regarding informed consent .................. 56
3.4. misunderstanding ...................................................................................... 57
3.4.1. case study: mr day’s case on therapeutic misconception...................... 57
3.4.2. interview on therapeutic misconception .............................................. 58
3.4.2.1. therapeutic misconceptions and the risks for research participants 58
3.4.2.2. Cases of therapeutic misconception and the diherence between
therapeutic and diagnostic misconception ..................................................... 59
3.4.3. Why is therapeutic misconception so prevalent? .................................. 61
3.4.4. Case commentary: mr day’s case ........................................................ 61
Module 4: informed consent – obtaining consent ................................................... 65
4.1. Decision to participate in research.............................................................. 65
4.1.1. Why do participants accept to partake in research? .............................. 65
4.1.2. Why do patients take part in research? ................................................. 66
4.2. Pressure .................................................................................................... 66
4.2.1. Pressure to participate in research ....................................................... 66
4.2.2. Case study: recruiting students ........................................................... 67
4.2.3. Case study: recruiting employees ........................................................ 68
4.2.4. Case commentaries............................................................................ 68
4.2.4.1. First case: recruiting students....................................................... 68
4.2.4.2. Second case: requiting employees ............................................... 68
4.3. Financial incentives ................................................................................... 69
4.3.1. Payments in research .......................................................................... 69
4.3.2. case study: space flight simulation ...................................................... 70
4.3.3. Bioethical issues in providing financial incentives to research participants
72
4.3.4. Interview on the use of financial incentives in research ......................... 73
4.3.5. Misconceptions about coercion and undue influence ........................... 74
4.4. Right to withdraw ....................................................................................... 74
4.4.1. Knowledge clip: the right to withdraw ................................................... 74
4.4.2. Challenges to the right to withdraw ...................................................... 75
,Module 5: vulnerable participants .......................................................................... 78
5.1. Vulnerability as a concept .......................................................................... 78
5.1.1. Knowledge clip: vulnerability ............................................................... 78
5.2. Vulnerable persons .................................................................................... 79
5.2.1. Vulnerable persons and vulnerable groups ........................................... 79
5.2.2. Research into the role of carers for Alzheimer’s patients ....................... 80
5.2.2.1. Case commentary: research into the role of carers for alzheimer’s
patients 80
5.2.3. capacity ............................................................................................. 82
5.2.4. Knowledge clip: capacity ..................................................................... 83
5.2.5. Assent ................................................................................................ 84
5.2.6. Case study: child refusing to participate in a cancer trial ....................... 88
5.2.6.1. Case commentary: child refusing to participate in cancer trial ....... 88
5.2.7. Child’s objection to non-beneficial research ........................................ 90
5.2.8. Proxy consent ..................................................................................... 90
5.3. Vulnerable groups ...................................................................................... 91
5.3.1. Risk of exploitation .............................................................................. 91
5.3.2. Interview on helicopter research .......................................................... 94
5.3.3. Ten simple rules to stop to helicopter research ..................................... 95
5.3.4. Interview on the ethical challenges of research in low- and middle-income
countries .......................................................................................................... 95
5.3.4.1. Part 1: globalization of clinical trials and the challenges related to
obtaining informed consent ........................................................................... 95
5.3.4.2. Mistrust, benefit sharing and balancing the risk of exploitation ....... 97
5.3.5. Benefit sharing.................................................................................... 98
5.3.6. Real-life case studies on benefit sharing ............................................ 100
5.4. Research in emergency situations ............................................................ 102
5.4.1. Introduction to research in emergency situations ............................... 102
5.4.2. Interview on research in emergency situations ................................... 102
5.4.2.1. Informed consent in emergency situations and deferred consent . 103
5.4.2.2. Role of societal or participant benefit and common good as
justifications for the lack of full informed consent ......................................... 104
, 5.4.2.3. Lowering the research standards, restoring the trust in research
process, the need for urgent response and balance between protecting and not
disproportionally excluding vulnerable individuals ........................................ 105
5.4.3. Interview on research without informed consent ................................ 106
5.5. Inclusion ................................................................................................. 106
5.5.1. The belmont report as a milestone for protectionism .......................... 106
5.5.2. Risks of exclusion: therapeutic orphans ............................................. 108
Module 6: privacy and confidentiality ................................................................... 112
6.1. General data protection regulation (GDPR) ................................................ 112
6.1.1. Distinction between privacy and confidentiality .................................. 112
6.1.2. Case studies: privacy ........................................................................ 113
6.1.3. Introduction to the GDPR .................................................................. 114
6.1.4. The role of a data protection ohicer (DPO) .......................................... 115
6.1.5. personal data in data-driven scientific research ................................. 122
6.1.6. six rules of thumb for the processing of personal data in scientific
research 123
6.3. Data sharing ............................................................................................ 125
6.3.1. Interview on data sharing .................................................................. 125
6.3.1.1. Data sharing, conflict between data sharing and maintaining research
participants privacy, data producers’ unwillingness to share data, role of GDPR in
data sharing and use of concerns for privacy to avoid responsibility to share data
125
6.3.1.2. Data access committees (DACs) ................................................ 127
6.3.2. Tension between data sharing and protection of privacy ..................... 128
6.3.3. Open science, data sharing and solidarity .......................................... 128
6.4. Big data research ..................................................................................... 129
6.4.1. Interview on big data ......................................................................... 129
6.4.1.1. Peculiarity of big data research and its diherence from regular
biomedical research .................................................................................... 129
6.4.1.2. The risks and benefits of big data research .................................. 130
6.4.1.3. Suggested solutions to the risks of big data research ................... 132
6.4.1.4. Some ethical concerns related to research based on publicly liable
data and the role of the ethics review committees in big data research........... 133
6.4.2. Facebook emotional contagion study ................................................ 134
, 6.5. Genetic research on historical samples .................................................... 136
6.5.1. Knowledge clip: ethical issues related to artifarct DNA........................ 136
6.5.2. Henrietta Lacks: the immortal cells that changed the world ................ 139
6.5.3. Lessons from HeLa cells ................................................................... 141
6.6. Return of results ...................................................................................... 142
6.6.1. Return of individual research results and incidental findings ............... 142
6.7. citizen science ......................................................................................... 142
6.7.1. interview on citizen science ............................................................... 143
6.7.2. Citizen scientists as human subjects ................................................. 145
6.7.3. Case study: the flint water crisis ........................................................ 145
Module 7: research integrity ................................................................................. 151
7.1. Research ethics and research integrity ...................................................... 151
7.1.1. What is the diherence between research ethics and research integrity 151
7.1.2. The research climate ......................................................................... 152
7.1.3. 7 reasons to care about integrity in research ....................................... 153
7.2. guidance and oversight mechanisms ........................................................ 153
7.2.1. The European code of conduct for research integrity........................... 153
7.2.2. Interview with a research integrity ohicer ........................................... 154
7.2.3. Interview on mentorship .................................................................... 156
7.2.3.1. Part 1: the role and value of mentorship ...................................... 156
7.2.3.2. poot mentorship, consequences and how institutions and
researchers can improve it ........................................................................... 158
7.2.4. supervisors tips to promote research integrity .................................... 159
7.3. Research misconduct and questionable research practices ...................... 159
7.3.1. What drives people to commit research misconduct?......................... 159
7.3.2. Falsification ...................................................................................... 159
7.3.3. Fabrication ....................................................................................... 160
7.3.4. Plagiarism ........................................................................................ 161
7.3.5. Interview on questionable research practices..................................... 163
7.3.5.1. Part 1: understanding research misconduct and questionable
research practices ....................................................................................... 163
7.3.5.2. Part 2: reducing questionable research practices ........................ 164
, 7.3.6. Conflict of interests........................................................................... 165
7.3.7. Everyone has a role in research integrity ............................................. 166
7.4. Authorship............................................................................................... 166
7.4.1. John, Paul and Mary: an authorship case ............................................ 166
7.4.2. Interview on criteria for authorship..................................................... 166
7.4.3. Gift and ghost authorship .................................................................. 167
7.4.4. Case study: authorship ..................................................................... 168
7.4.5. Reading: is contributorship suhicient for today’s collaborative research?
169
7.5. Consequences of research misconduct and QRPs .................................... 169
7.5.1. Discussion assignment: consequences of research misconduct and QRPs
169
7.5.2. Consequences of research misconduct and QRPs ............................. 169
,Module 1: responsibility in research
Ø Learning goals:
- Understand the moral identity of the researcher
- Be able to reflect on the foundational questions of research
- Be able to reflect on the role and responsibility of researchers in society
1.1. What is a good researcher?
1.1.1. Introduction to virtue ethics
ð How to become better persons
ð It is fundamental that researchers have the virtues of good people as well
as those of good researchers
ð A key question of virtue ethics: how to mold individual character based on
models of virtue è how can we become a good person?
- You van strive to develop a virtuous character
1.1.1.1. Virtue considerations
• A virtue mat be considered a character trait but It’s more than this:
- It’s entrenched In the mindset of a person
• Virtues are visible in the considerations one has when taking
action
- = diherent form using for example deontological rules and
ethical behavior
- For example: a courageous person is one who values courage
not because they say they do but because they take
considerations regarding courage into account and thinking
about what to do in a certain situation
• The doctrine of the mean
- A courageous person tries to strike a balance between being
reckless and cowardly
- Virtuous behavior is about finding a balance between excess
and deficiency, depending on the situation
• Practical wisdom which comes with life experience helps a
virtuous person while making such decisions
- It helps us to reason in a good way
- But why would we do this? è eudaimonia
1.1.1.1.1. Eudaimonia
o It’s dihicult to translate but is commonly described as living
well, welfare or human flourishing
, o Alasdair who can be considered a contemporary virtue
ethicist, applies to society as a whole
1.1.1.2. External goods
• So if our characters reflect virtues we will not only serve ourselves,
it’s also essential and beneficial to society as a whole
• External goods
- not specific to a practice
- can be obtained in several ways
• examples of such goods are power and money
- in the case of money you can become richer by working more
• external goods = later reformulated as ‘goods of ehectiveness’
- only to obtain through a particular practice and which have as
a characteristic that the achievement is good for the whole
community who participate in the practice
• each practice has an overriding end
- for example, if you want to improve the reputation of your
organization by external communication, you need to engage in
this kind of communication
- if this is practiced in a good way the organization and
stakeholders will benefit from it
- the community of practitioners of corporate communication
can learn from this as well and consequently develop their own
external communication skills
• a virtue in a sense is an acquired human quality that enables us to
achieve internal goods
• While you get socialized in you practice as a communication
professional you will practice your virtues, strive at internal goods,
deliver good communication products and thus serve a common
good
1.1.2. From virtues to virtuous researchers
ð How do we become good researchers?
ð The general principles of virtue ethics ca also apply to researchers
ð The only real diherence that researchers will need to develop a set of
specific research virtues, but what are the virtues of a good researcher?
- Critical
- Passionate
- Certain resilience
- Integrity
- Curious
, - Empathy
- Perseverance
- Teamwork
- Honesty
- Transparent
ð Results of a survey conducted by Pennock & Miller which measured the
endorsement of scientific virtues by exemplary scientists
1.2. Research groups as moral communities
Ø What do you think the role of the researcher is in society?
- With the knowledge we generate, we try to contribute to a solution for
problems that there are in the society (cancer therapy)
- The role of a researcher is to help people understand the world around them
- Don’t forget that out healthcare comes with an increasing cost, the impact
that we have for society throughout research, is trying to reduce these costs
for health care
- We start form patients participating in clinical trials because we’re focusing a
clinically relevant question. I think the aim is really to cure patients or to get
rid of certain side ehects that they develop.
- The research that we do, creating living implants for patients who currently
cannot be helped with the existing methods, is something that obviously has
societal value
1.2.1. The social value requirement
ð Research needs to comply with the social value requirement
- Nuremberg code states that research needs to produce “fruitful
results for the good of society”
- The Helsinki declaration states “medical research involving human
subjects may only be conducted if the importance of the objective
outweighs the inherent risks and burdens to the research subjects”
Module 1: responsibility in research ......................................................................... 8
1.1. What is a good researcher? .......................................................................... 8
1.1.1. Introduction to virtue ethics................................................................... 8
1.1.1.1. Virtue considerations ..................................................................... 8
1.1.1.1.1. Eudaimonia ............................................................................... 8
1.1.1.2. External goods ............................................................................... 9
1.1.2. From virtues to virtuous researchers ...................................................... 9
1.2. Research groups as moral communities ..................................................... 10
1.2.1. The social value requirement ............................................................... 10
1.2.2. The social value of clinical research ..................................................... 11
1.2.3. interview on responsible research and innovation (RRI)......................... 12
Module 2: ethics infrastructure and governance .................................................... 14
2.1. Scandals and abuse in mid 20th century and the resulting guidelines ............ 14
2.1.1. American context and the Belmont report ............................................ 15
2.1.2. Research ethics and law ..................................................................... 17
2.1.2.1. The treaty on the functioning of the European Union (TFEU) ........... 17
2.2. Ethical requirements for research ............................................................... 18
2.2.1. Risk-benefit assessment ..................................................................... 18
2.2.1.1. Assessing and minimizing risks ..................................................... 19
2.2.1.2. Assessing and maximizing the benefits ......................................... 19
2.2.2. Clinical trials: how do they work and what are the ethical requirements? 20
2.2.2.1. Huntington’s disease youth organization (HDYO) ........................... 20
2.2.3. case study: the polyIran trial ................................................................ 21
2.2.4. Randomized controlled trials: what are they and what are the ethical
issues 21
2.2.5. Placebo-controlled trials ..................................................................... 22
2.3. Ethics committees ..................................................................................... 23
2.3.1. Interview with the chair of the SMEC committee a KU Leuven ................ 23
2.3.2. Interview with the chair of research ethics committee UZ/KU Leuven .... 25
2.3.3. Interview with KU Leuven researchers: ethics review............................. 28
, 2.3.4. Interview on international research ethics governance .......................... 30
2.4. Further resources ...................................................................................... 32
2.4.1. Key terms ........................................................................................... 32
2.4.1.1. Risks-benefit assessment ............................................................ 32
2.4.1.2. Clinical trial ................................................................................. 33
2.4.1.3. Randomized controlled trial ......................................................... 33
2.4.1.4. Placebo ....................................................................................... 33
2.4.1.5. Ethics committee......................................................................... 33
Module 3: informed consent: informing participants .............................................. 36
3.1. What is informed consent and why is it important? ...................................... 36
3.1.1. Informed consent and respect for persons ........................................... 37
3.1.2. Interview on informed consent: basing autonomy in dignity................... 42
3.1.2.1. the historical background of the concept of informed consent ....... 42
3.1.2.2. The limitations of autonomy as an ethical justification for doing
research 43
3.1.2.3. his proposal that we use human dignity to justify doing research on
human subjects ............................................................................................ 44
3.1.3. Key aspects of informing participants .................................................. 44
3.2. Deception: a challenge for informed consent .............................................. 46
3.2.1. Milgram’s obedience study .................................................................. 46
3.2.2. Interview on risks, benefits and safeguards of deceptive studies ........... 47
3.2.2.1. The harms and benefits associated to the use of deception in
research 47
3.2.2.2. Possible safeguards and harm mitigation methods and presumed &
retrospective consent .................................................................................... 49
3.3. Understanding ........................................................................................... 51
3.3.1. Informed consent form........................................................................ 51
3.3.2. Understanding of research participants ............................................... 53
3.3.3. The reality of informed consent ............................................................ 54
3.3.4. Readability of informed consent forms ................................................. 54
3.3.4.1. What is readability? ..................................................................... 54
3.3.4.2. How can we measure readability? ................................................ 54
3.3.4.3. What readability score is appropriate for consent forms................. 55
, 3.3.4.4. How to measure the readability of a text? ...................................... 56
3.3.5. Readable: using the SMOG formula ..................................................... 56
3.3.6. eConsent: New developments regarding informed consent .................. 56
3.4. misunderstanding ...................................................................................... 57
3.4.1. case study: mr day’s case on therapeutic misconception...................... 57
3.4.2. interview on therapeutic misconception .............................................. 58
3.4.2.1. therapeutic misconceptions and the risks for research participants 58
3.4.2.2. Cases of therapeutic misconception and the diherence between
therapeutic and diagnostic misconception ..................................................... 59
3.4.3. Why is therapeutic misconception so prevalent? .................................. 61
3.4.4. Case commentary: mr day’s case ........................................................ 61
Module 4: informed consent – obtaining consent ................................................... 65
4.1. Decision to participate in research.............................................................. 65
4.1.1. Why do participants accept to partake in research? .............................. 65
4.1.2. Why do patients take part in research? ................................................. 66
4.2. Pressure .................................................................................................... 66
4.2.1. Pressure to participate in research ....................................................... 66
4.2.2. Case study: recruiting students ........................................................... 67
4.2.3. Case study: recruiting employees ........................................................ 68
4.2.4. Case commentaries............................................................................ 68
4.2.4.1. First case: recruiting students....................................................... 68
4.2.4.2. Second case: requiting employees ............................................... 68
4.3. Financial incentives ................................................................................... 69
4.3.1. Payments in research .......................................................................... 69
4.3.2. case study: space flight simulation ...................................................... 70
4.3.3. Bioethical issues in providing financial incentives to research participants
72
4.3.4. Interview on the use of financial incentives in research ......................... 73
4.3.5. Misconceptions about coercion and undue influence ........................... 74
4.4. Right to withdraw ....................................................................................... 74
4.4.1. Knowledge clip: the right to withdraw ................................................... 74
4.4.2. Challenges to the right to withdraw ...................................................... 75
,Module 5: vulnerable participants .......................................................................... 78
5.1. Vulnerability as a concept .......................................................................... 78
5.1.1. Knowledge clip: vulnerability ............................................................... 78
5.2. Vulnerable persons .................................................................................... 79
5.2.1. Vulnerable persons and vulnerable groups ........................................... 79
5.2.2. Research into the role of carers for Alzheimer’s patients ....................... 80
5.2.2.1. Case commentary: research into the role of carers for alzheimer’s
patients 80
5.2.3. capacity ............................................................................................. 82
5.2.4. Knowledge clip: capacity ..................................................................... 83
5.2.5. Assent ................................................................................................ 84
5.2.6. Case study: child refusing to participate in a cancer trial ....................... 88
5.2.6.1. Case commentary: child refusing to participate in cancer trial ....... 88
5.2.7. Child’s objection to non-beneficial research ........................................ 90
5.2.8. Proxy consent ..................................................................................... 90
5.3. Vulnerable groups ...................................................................................... 91
5.3.1. Risk of exploitation .............................................................................. 91
5.3.2. Interview on helicopter research .......................................................... 94
5.3.3. Ten simple rules to stop to helicopter research ..................................... 95
5.3.4. Interview on the ethical challenges of research in low- and middle-income
countries .......................................................................................................... 95
5.3.4.1. Part 1: globalization of clinical trials and the challenges related to
obtaining informed consent ........................................................................... 95
5.3.4.2. Mistrust, benefit sharing and balancing the risk of exploitation ....... 97
5.3.5. Benefit sharing.................................................................................... 98
5.3.6. Real-life case studies on benefit sharing ............................................ 100
5.4. Research in emergency situations ............................................................ 102
5.4.1. Introduction to research in emergency situations ............................... 102
5.4.2. Interview on research in emergency situations ................................... 102
5.4.2.1. Informed consent in emergency situations and deferred consent . 103
5.4.2.2. Role of societal or participant benefit and common good as
justifications for the lack of full informed consent ......................................... 104
, 5.4.2.3. Lowering the research standards, restoring the trust in research
process, the need for urgent response and balance between protecting and not
disproportionally excluding vulnerable individuals ........................................ 105
5.4.3. Interview on research without informed consent ................................ 106
5.5. Inclusion ................................................................................................. 106
5.5.1. The belmont report as a milestone for protectionism .......................... 106
5.5.2. Risks of exclusion: therapeutic orphans ............................................. 108
Module 6: privacy and confidentiality ................................................................... 112
6.1. General data protection regulation (GDPR) ................................................ 112
6.1.1. Distinction between privacy and confidentiality .................................. 112
6.1.2. Case studies: privacy ........................................................................ 113
6.1.3. Introduction to the GDPR .................................................................. 114
6.1.4. The role of a data protection ohicer (DPO) .......................................... 115
6.1.5. personal data in data-driven scientific research ................................. 122
6.1.6. six rules of thumb for the processing of personal data in scientific
research 123
6.3. Data sharing ............................................................................................ 125
6.3.1. Interview on data sharing .................................................................. 125
6.3.1.1. Data sharing, conflict between data sharing and maintaining research
participants privacy, data producers’ unwillingness to share data, role of GDPR in
data sharing and use of concerns for privacy to avoid responsibility to share data
125
6.3.1.2. Data access committees (DACs) ................................................ 127
6.3.2. Tension between data sharing and protection of privacy ..................... 128
6.3.3. Open science, data sharing and solidarity .......................................... 128
6.4. Big data research ..................................................................................... 129
6.4.1. Interview on big data ......................................................................... 129
6.4.1.1. Peculiarity of big data research and its diherence from regular
biomedical research .................................................................................... 129
6.4.1.2. The risks and benefits of big data research .................................. 130
6.4.1.3. Suggested solutions to the risks of big data research ................... 132
6.4.1.4. Some ethical concerns related to research based on publicly liable
data and the role of the ethics review committees in big data research........... 133
6.4.2. Facebook emotional contagion study ................................................ 134
, 6.5. Genetic research on historical samples .................................................... 136
6.5.1. Knowledge clip: ethical issues related to artifarct DNA........................ 136
6.5.2. Henrietta Lacks: the immortal cells that changed the world ................ 139
6.5.3. Lessons from HeLa cells ................................................................... 141
6.6. Return of results ...................................................................................... 142
6.6.1. Return of individual research results and incidental findings ............... 142
6.7. citizen science ......................................................................................... 142
6.7.1. interview on citizen science ............................................................... 143
6.7.2. Citizen scientists as human subjects ................................................. 145
6.7.3. Case study: the flint water crisis ........................................................ 145
Module 7: research integrity ................................................................................. 151
7.1. Research ethics and research integrity ...................................................... 151
7.1.1. What is the diherence between research ethics and research integrity 151
7.1.2. The research climate ......................................................................... 152
7.1.3. 7 reasons to care about integrity in research ....................................... 153
7.2. guidance and oversight mechanisms ........................................................ 153
7.2.1. The European code of conduct for research integrity........................... 153
7.2.2. Interview with a research integrity ohicer ........................................... 154
7.2.3. Interview on mentorship .................................................................... 156
7.2.3.1. Part 1: the role and value of mentorship ...................................... 156
7.2.3.2. poot mentorship, consequences and how institutions and
researchers can improve it ........................................................................... 158
7.2.4. supervisors tips to promote research integrity .................................... 159
7.3. Research misconduct and questionable research practices ...................... 159
7.3.1. What drives people to commit research misconduct?......................... 159
7.3.2. Falsification ...................................................................................... 159
7.3.3. Fabrication ....................................................................................... 160
7.3.4. Plagiarism ........................................................................................ 161
7.3.5. Interview on questionable research practices..................................... 163
7.3.5.1. Part 1: understanding research misconduct and questionable
research practices ....................................................................................... 163
7.3.5.2. Part 2: reducing questionable research practices ........................ 164
, 7.3.6. Conflict of interests........................................................................... 165
7.3.7. Everyone has a role in research integrity ............................................. 166
7.4. Authorship............................................................................................... 166
7.4.1. John, Paul and Mary: an authorship case ............................................ 166
7.4.2. Interview on criteria for authorship..................................................... 166
7.4.3. Gift and ghost authorship .................................................................. 167
7.4.4. Case study: authorship ..................................................................... 168
7.4.5. Reading: is contributorship suhicient for today’s collaborative research?
169
7.5. Consequences of research misconduct and QRPs .................................... 169
7.5.1. Discussion assignment: consequences of research misconduct and QRPs
169
7.5.2. Consequences of research misconduct and QRPs ............................. 169
,Module 1: responsibility in research
Ø Learning goals:
- Understand the moral identity of the researcher
- Be able to reflect on the foundational questions of research
- Be able to reflect on the role and responsibility of researchers in society
1.1. What is a good researcher?
1.1.1. Introduction to virtue ethics
ð How to become better persons
ð It is fundamental that researchers have the virtues of good people as well
as those of good researchers
ð A key question of virtue ethics: how to mold individual character based on
models of virtue è how can we become a good person?
- You van strive to develop a virtuous character
1.1.1.1. Virtue considerations
• A virtue mat be considered a character trait but It’s more than this:
- It’s entrenched In the mindset of a person
• Virtues are visible in the considerations one has when taking
action
- = diherent form using for example deontological rules and
ethical behavior
- For example: a courageous person is one who values courage
not because they say they do but because they take
considerations regarding courage into account and thinking
about what to do in a certain situation
• The doctrine of the mean
- A courageous person tries to strike a balance between being
reckless and cowardly
- Virtuous behavior is about finding a balance between excess
and deficiency, depending on the situation
• Practical wisdom which comes with life experience helps a
virtuous person while making such decisions
- It helps us to reason in a good way
- But why would we do this? è eudaimonia
1.1.1.1.1. Eudaimonia
o It’s dihicult to translate but is commonly described as living
well, welfare or human flourishing
, o Alasdair who can be considered a contemporary virtue
ethicist, applies to society as a whole
1.1.1.2. External goods
• So if our characters reflect virtues we will not only serve ourselves,
it’s also essential and beneficial to society as a whole
• External goods
- not specific to a practice
- can be obtained in several ways
• examples of such goods are power and money
- in the case of money you can become richer by working more
• external goods = later reformulated as ‘goods of ehectiveness’
- only to obtain through a particular practice and which have as
a characteristic that the achievement is good for the whole
community who participate in the practice
• each practice has an overriding end
- for example, if you want to improve the reputation of your
organization by external communication, you need to engage in
this kind of communication
- if this is practiced in a good way the organization and
stakeholders will benefit from it
- the community of practitioners of corporate communication
can learn from this as well and consequently develop their own
external communication skills
• a virtue in a sense is an acquired human quality that enables us to
achieve internal goods
• While you get socialized in you practice as a communication
professional you will practice your virtues, strive at internal goods,
deliver good communication products and thus serve a common
good
1.1.2. From virtues to virtuous researchers
ð How do we become good researchers?
ð The general principles of virtue ethics ca also apply to researchers
ð The only real diherence that researchers will need to develop a set of
specific research virtues, but what are the virtues of a good researcher?
- Critical
- Passionate
- Certain resilience
- Integrity
- Curious
, - Empathy
- Perseverance
- Teamwork
- Honesty
- Transparent
ð Results of a survey conducted by Pennock & Miller which measured the
endorsement of scientific virtues by exemplary scientists
1.2. Research groups as moral communities
Ø What do you think the role of the researcher is in society?
- With the knowledge we generate, we try to contribute to a solution for
problems that there are in the society (cancer therapy)
- The role of a researcher is to help people understand the world around them
- Don’t forget that out healthcare comes with an increasing cost, the impact
that we have for society throughout research, is trying to reduce these costs
for health care
- We start form patients participating in clinical trials because we’re focusing a
clinically relevant question. I think the aim is really to cure patients or to get
rid of certain side ehects that they develop.
- The research that we do, creating living implants for patients who currently
cannot be helped with the existing methods, is something that obviously has
societal value
1.2.1. The social value requirement
ð Research needs to comply with the social value requirement
- Nuremberg code states that research needs to produce “fruitful
results for the good of society”
- The Helsinki declaration states “medical research involving human
subjects may only be conducted if the importance of the objective
outweighs the inherent risks and burdens to the research subjects”
