Introducing ETHICS and approval processes (Part 1)

Dr Vivien Rolfevivrolfe.com

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PART 1 of 2Introduction to ethics

Learning outcomes

• This resource will help you understand:– What ethics are and why they are important.– Some historical principles and how ethics originated.– How ethics might be important for typical university

research projects.– Flow diagrams for university and NHS ethical approval.– Where ethics fits into our research planning and

dissemination.– Resources and documents you might find useful.

What is /are ethics?

http://www.youtube.com/watch?v=ZIaHxC7BT0A

What to expect from this resource?

• It will not discuss the theories underpinning the subject of ethics.

• Is intended as a basic introduction for undergraduate students embarking on research for the first time.

• You may or may not need to gain ethical approval for your dissertations in your university, but it is important to understand ethical principles.

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Ethics are all around us!

Early professional standards…• Hippocrate’s writings give mention to some of

the principles we comply with today.

(Public domain image)

“I will not give a lethal drug to anyone if I am asked, nor will I advise such a plan; and similarly I will not give a woman a pessary to cause an abortion”.

“Whatever I see or hear in the lives of my patients, whether in connection with my professional practice or not, which ought not to be spoken of outside, I will keep secret, as considering all such things to be private”.Translated by Michael North, 2002.

…and lack of standards

• Henrietta Lacks.• Born 1920 in Virginia USA.• Died of cervical cancer in 1951 (31

years).• Few hospitals for black patients (went

to John Hopkins). Radium treatment applied to cervix. Tissue taken for culture.

• There was no code of ethics. No system for gaining permission. Her family had initially said no, yet none of her body organs remained after autopsy.

(Public domain image)

The disaster continued

• HeLa cells. Cells grew so rapidly and not confined by the space of the vessel. Used to test polio vaccine.

• Cells used to develop cell culture techniques (media, freezing, handling).

• Hela cells became mass produced and big industry around the world.

• Early research used prisoner volunteers injecting Hela. No consent taken. Not informed it was cancer.

• Henry Beecher talked about consent for medical research (Henry Beecher 1966).

Nuremberg Code

• Following 1947 Nuremberg war trials, a 10 point code of ethics was set up to govern human experimentation “the voluntary consent of the human subject is absolutely essential”.

• The term “informed consent” didn’t appear in law courts until 1957.

Declaration of Helsinki

• Adopted by the World Medical Association in Helsinski in June 1964 and subsequently updated.

• Governing “human subjects, including research on identifiable human material and data”.

• Establishing ethical review processes.

Other acts

• Human Tissue Act• Data Protection Act• Nuffield Council on Bioethics• Home Office Animal License / Project and

Personal

Introducing ETHICS and approval processes (Part 2)

Dr Vivien Rolfevivrolfe.com

CC BY SA unless images otherwise stated

PART 2 of 2Typical university

undergraduateresearch projects?

Children / patients / NHS / clinical settings

e.g. clinical studies.

Healthy human volunteers (students!)

e.g. physiology laboratory

Human tissuee.g. blood samples,

human biopsies, cell culture Animal

experimentse.g. in vitro / in vivo testing

Human opinions – qualitative

researche.g. questionnaires

or interviews

LOW RISK

HIGH RISK

Human data analysis

e.g. pre-existing medical data,

audit, service or technical

evaluation

Literature review

e.g. biased review, plagiarism, misleading

recommendations.

Typical university process

Ethical review form

Ethical Review Panel

/ InternalAppraisal

FeedbackYES

MODIFICATIONNO

Research proposal; CVs of student and supervisor; research paperwork (informationsheet, informed consent, surveys).

Typical university / NHS process

Ethical review form

Ethical Review Panel

/ InternalAppraisa

l

FeedbackYES

MODIFICATIONNO

HospitalResearch and Development Office Input

NHS Ethics(NRES)

Weeks / months Months / years

Informed consent• Be of the same mind – trust / cooperation

between researcher / clinician and participant / subject.

• Requires the participant information sheet and a consent form to sign.

• The validity of consent is based on the following:• The provision of accurate information sheets to make a

decision.• The participant understands the information.• Is competent to give consent.• Is not coerced.

Confidentiality• Found within the Hippocratic Oath “I will not

divulge, reckoning that all such should be kept secret”.

• Research must comply with the UK 1998 Data Protection Act governing the use of personal data (name, age, date of birth) and its collection, use, disclosure and storage.

• Data should be anonymised.

Other research requirements

• Includes ethics and items such as safe working and good practice.

– Health and safety:• Risk assessments for laboratory working• COSHH for safe use of chemicals

Ethical review form

Ethical Review Panel

/ InternalApprais

al

FeedbackYES

MODIFICATIONNO

Research proposalCVs of student / supervisorAll research paperworkPatient information sheetInformed consent sheetQuestionnaires / interviewquestions

Ethical review form

Ethical Review Panel/ InternalAppraisal

FeedbackYES

MODIFICATIONNO

Research proposalCVs of student / supervisorAll research paperworkPatient information sheetInformed consent sheetQuestionnaires / interviewquestions

Where in our research pipeline?

Learning outcomes

• This resource will help you understand:– What ethics are and why they are important.– Some historical principles and how ethics originated.– How ethics might be important for typical university

research projects.– Flow diagrams for university and NHS ethics.– Where ethics fits into our planning and

dissemination.– Further reading.

Resources• Henry Beecher (1966). (Available:

http://www.nejm.org/doi/full/10.1056/NEJM199707243370419 )

• Michael North (2002). Hippocratic Writings. The National Library of Medicine, (Available: http://www.nlm.nih.gov/hmd/greek/ greek_oath.html )

• MOCK ethical review checklist: Open educational resource (Available http://vivrolfe.com/research-projects/introduction-to-ethics-for-university-undergraduate-students/).

• MOCK consent form: Open educational resource (Available http://vivrolfe.com/research-projects/introduction-to-ethics-for-university-undergraduate-students/).

• MOCK patient information sheet: Open educational (Available http://vivrolfe.com/research-projects/introduction-to-ethics-for-university-undergraduate-students/).