Institutional Procedures as a Tool to Promote Responsible Research

Environment

Hakan S. Orer, MD, PhD Koç University School of Medicine

ORPHEUS Turkish Pharmacological Society

EPHAR 7th European Congress of Pharmacology

Istanbul, 29.06.2016

Turkish Pharmacological Society celebrates its 50th anniversary

• Congratulations!

How frequent is the irresponsible conduct?

• The rate of retraction is faster than the increase in total number of scientific publications

Retracted papers per fiscal year (FY) Percent increase

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Aug-10 Jan-11 Jun-11 Nov-11 Apr-12 Sep-12 Feb-13 Jul-13 Dec-13 May-14 Oct-14 Mar-15 Aug-15 Jan-16 Jun-16

Retracted papers

Institutional dilemma

• Failure to transmit codes of conduct from one generation to the next may affect scientific integrity at a personal level

Decaying institutional culture

Expansion of the research system

Accelerated pace of the research

“Publish or perish” pressure

Tough competition for limited funding

Loss of “institutional memory” on best practices

Ensuring research integrity

• Ecosystem

Individual researchers

Research institutions

Funding agencies

Professional societies

Science academies

Legislative bodies

Judiciary bodies

Focus:

• The role of institutions in the responsible conduct of scientific research

SUPERVISOR GRADUATE STUDENT

GRADUATE SCHOOL

FUNDING AGENCIES JOURNAL

EDITORS

PROFESSIONAL BODIES

Institutions need to put effort…

• Promotion of research integrity

• Adoption of good practices

– Education & training

– Handling irresponsible research: investigations, penalties…

Consistency and complementarity are the key

A working research ecosystem

Research Environment

Training

Reward system

Research output

PhDs

Institutional tools to oversee scientific conduct

• Curriculum

• Guidelines

• Common understanding of key definitions

• Policies & procedures for detecting incidents of misconduct

• Discourage questionable research practices

Evidence for Institutional Best Practices

• Does the curriculum contain courses related to: the integrity of the research process? the personal development of the PhD candidates?

• Do PhD candidates apply for ethical approval of their research and/or thesis projects?

• Is there any institutional guideline on data recording and laboratory notebook keeping?

• Do PhD candidates sign an "ethical conduct contract" upon starting their thesis studies?

• Do PhD candidates and their supervisors sign a contract on mutual responsibilities and duties?

All stakeholders must get involved at different layers

NATIONAL

INDIVIDUAL

INSTITUTIONAL

ORPHEUS Best Practice Questionnaire

• 63 responders from 31 countries

4 2

1

2

1 2

1

2

2

2

2 3

1 1 1

1

1

1

1

2

1

7

2

1

1

1

2

10

2

Canada 1

1

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Questionnaire turnout

Description Number

• ORPHEUS members (2016) 105

• Participants 63

• Number of Institutions, participated in the survey 51

ORPHEUS member institutions

Responders from non-member institutions

48

3

• More than one answer from the same institution 9

• Academics vs Students

Academic staff

Students

57

6

• Members only

Academic staff

Students

45

3

Questionnaire

• Responders are mostly senior faculty members

61,30% 14,50%

4,80%

6,50%

12,90%

Title

Professor

Associate professor

Assistant professor

Dr

Other 78,70%

8,20%

6,60%

3,30% 3,30%

Position

Academic (Faculty)

Administrative

PhD Student

MSc Student

Other

Feedback collection from PhD students

• More than half of the responders claim that feedback from PhD students is obtained at every milestone of the study

• More than 80% declared that some feedback is obtained during PhD study

52,38%

30,16%

4,76%

1,59% 7,94%

3,17%

Yes, periodically at every milestone of theirstudies

Yes, but not systematic

Yes, only after grade courses

Yes, only at the exit

No

Other

Supervisors

1,59%

50,79%

25,40%

22,22%

How many supervisors do your PhD candidates usually have?

None

1 Supervisor

2 Supervisors

Other75,81%

24,19%

Do your PhD candidates have the right to choose their supervisors?

Yes

No

Does your institution have a formal training program for

supervisors?

Yes, mandatory

Yes, voluntary

No

Integration into the scientific community

• PhD candidates are encouraged to go and present their studies at scientific meetings

• Being able to publish the “thesis work” is widely accepted

80,60%

14,50%

4,80%

Publications out of thesis project

Yes, mandatory

Yes, voluntary

No73,00%

14,30%

6,30%

6,30%

Going to meetings

Yes

No

Not sure...

Other

How these goals can be achieved?

• What is the institutional climate that fosters high standards of scientific research?

• How PhD students are guided throughout their studies?

Curriculum

• While mandatory training in bioethics and biostatistics has become almost universal, there is room for improvement in topics related to “good scientific practice”

• Laboratory animal use and good clinical practice courses are mostly offered if deemed necessary

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Bioethics

Responsible conduct

Biosafety

Intellectual property rights

GCP (Good Clinical Practice)

Laboratory animal use

Data keeping, laboratory notebook

Experimental design

Biostatistics

Other

Formal Training Courses

Offered courses

Mandatory

In the way to become independent researcher

• Most generic skills training is focused on boosting research performance, yet other aspects of the daily routine are needed to be taken care of

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Time management

Stress management

Networking

Conflict resolution

Presentation skills

Grant writing

Scientific publication skills

Generic skills training

Institutional best practices

• Ethics committees are largely in place • Less than half of the responders pointed out that there

is a guideline on data recording

90,50%

90,50%

31,70%

29% 0%

50%

100%

Ethics committee approval

38,10%

61,90%

Guidelines on data recording & laboratory book keeping

Yes

NoProjects on Social studies

Projects on Human Subjects

Projects on Animal subjects

Projects on Field studies

Mentor-mentee relationship: How structured?

• The majority of institutions stay off the mentor-mentee relationship

Ethical conduct contract

Yes

No

Mentor-mentee contract

Yes

No

Conclusion

• Institutional climate is important in the maintenance of scientific integrity

• A more structured mentor-mentee relationship could help to foster a quality culture

• Institutions concentrate their “training” effort towards the making of science, rather than generic skills

– More emphasis may be needed to develop generic skills of the candidates

Sustainability is the key

Thank you…