Ethics in

Research

Session ObjectivesWhat are ethics?

Why are ethics important?

What are the ethical issues I need to consider in my research?

Do I need ethical approval for my research?

From where do I obtain ethics approval?

Session Objectives

What are ethics?

Why are ethics important?

What are the ethical issues I need to consider in my research?

Do I need ethical approval for my research?

From where do I obtain ethics approval?

What are Ethics?

Definition: What is deemed to be right or wrong; good and evil; moral values.

What influences ethical beliefs?• Culture• Religion• Past experiences• Personal beliefs

Question: What are your views on stem cell research?

Ethical Doctrines

Deontology: “Duty of science”; What is my moral duty? What are my moral obligations? How do I weigh one moral duty against another?

Teleological theory: “Science of ends”; adherence to independent moral rules or duties.

Rights based theories: base on human rights (positive and negative).

Utilitarianism: the quantitative maximization of good consequences.

Session Objectives

What are ethics?

Why are ethics important?

What are the ethical issues I need to consider in my research?

Do I need ethical approval for my research?

From where do I obtain ethics approval?

Why are ethics important? A history of unethical research

1800’sFrance:- hospital patients used systematically to develop classification of diseaseUSA:- Slaves used to study effects of heat stroke and cure for typhus

1st Century ADRome:- Aulus Cornelius Celsus:- experimentation on prisoners.

2nd Century ADPersia:- “Experiment freely but not on people of high rank or political importance”.

1932 – 1972USA:- Tuskegee Syphilis Study

1939-1945 (World War II)Germany:- Nazi human experimentationJapan:- Vivisection: Immunity from prosecution exchanged for results

1940’s & 1950’sUK:- (Porton Down) MOD tested nerve gas on human subjects leading to a death

Regulating Research

• 1947 - Nuremberg Code

• 1964 - Declaration of Helsinki

• 1979 - Belmont Principles

• 1982/2002 – WHO/CIOMS International guidelines for biomedical research involving human subjects

• 2004 – EU Directive on Clinical Trials

Prosecutions resulting from unethical research has produced the following recommendations for practice

Session Objectives

What are ethics?

Why are ethics important?

What are the ethical issues I need to consider in my research?

Do I need ethical approval for my research?

From where do I obtain ethics approval?

Ethical issues in research:

1. Autonomy

2. Confidentiality/anonymity

3. Beneficence

4. Justice

5. Nonmaleficence

You should explain how your research will be ethical using the following headings:

Don’t write…

“…as it is a survey there are no ethical considerations.”

Or…

“Consent will be obtained and all data will be kept confidentially. All patients will be treated fairly not

be treated harmfully.”

Autonomy

Self-determination: All adults are presumed to have decision-making capacity and are therefore afforded the right to self-determination, that is, the freedom to make decisions for themselves in all areas of their lives.

Autonomy (from the Greek “self-rule”): the ability or capacity to make informed choices, free of coercion, based on one's own personal beliefs and values.

Rational self-awareness: when does this occur? what about patients in fluctuating state e.g. early dementia?

Exploring capacity

when requesting consent an individual must have the ability to:

1. understand and retain the information relevant to the decision in question;

2. believe that information;

3. weigh that information in the balance and arrive at a choice.

Question: Is the participant globally competent or contextually capable?

“In the case of severely ill or unconscious patient in the U.K, no one can give consent for another adult”

CSP Information Paper No. RES 7 (2001)

“Informed consent must be obtained from an incapacitated patient's legal representative prior to his/her participation in trials of medicines.”Medicines for human use (clinical trials) regulations 2004

(S.I.2004/1031) – Articles 3&5

Children• 16 and 17 year olds are presumed to have the

competence to give consent for themselves.

• <16 year olds who have the capacity to understand can also give consent (although their parents will ideally be involved).

• In other cases, some-one with parental responsibility must give consent on the child’s behalf, unless they cannot be reached in an emergency.

• If a competent child consents to treatment, a parent cannot over-ride that consent.

• Legally, a parent can consent if a competent child <16 refuses, but it is likely that taking such a serious step will be rare.

Gaining informed written consent

• All information that a rational person would require:

• Purpose• Researcher, organisation and funder• Basis for selection (inclusion and exclusion criteria)• Duration, frequency, length of tests• side effects, risks • success rates• Potential benefits and alternatives• Assurances of confidentiality

Confidentiality - Data Protection Act

def: entrusted with secrets“Not sharing/revealing individuals data” (OED)

• Access to data – who?

• Medical records – consent needed?

• Storage of data – where?

Confidentiality – vs. safety

Ethical dilemma:

What would you do if, when interviewing a participant, they revealed to you that they had broken the law?

Anonymity

• def: of unknown name, undeclared source or authorship.

(OED)

– Anonymous - cannot be traced back

– Anonymised - using codes

Beneficence - Social or scientific value

Is it likely to be published or disseminated?

Are the results generalisable?

Is the hypothesis significant?

Does it replicate other studies?

Ask yourself….

Justice - Fair participant selection

Does my sample reflect the population it is taken from?

Am I researching a vulnerable group?They should not be included where alternatives exist

Are my inclusion and exclusion scientifically justified?

Ask yourself…

Nonmaleficence – Is there a favourable risk-benefit ratio?

• Is there real uncertainty (Equipoise)?

• Have I minimised participant risk

• Have I maximised participant benefit

• Are risks proportional to the benefits

• Are the interventions plausible?

Ask yourself…

Session Objectives

What are ethics?

Why are ethics important?

What are the ethical issues I need to consider in my research?

Do I need ethical approval for my research?

From where do I obtain ethics approval?

Do I need ethics approval or my research?

Am I using participants? Am I using participants?

If NO then…If NO then…Start literature Start literature based project based project

If YES then…If YES then…Are they NHS patients?Are they NHS patients?

If YES then…Send research proposal to MMU Physio Ethics

If NO then…Send research proposal to

MMU Physio Ethics

When Successful, send to NRES

NB: Post hoc significant revisions of project would need to be passed by NB: Post hoc significant revisions of project would need to be passed by the REC againthe REC again

Ethical review by the NHS Research Ethics Service (NRES) is required for:

• Patients and users of the NHS

• Relatives of carers of patients and users of the NHS

• Access to data, organs or other bodily material of past or present NHS patients

• Foetal material and IVF involving NHS patients

• The recently dead in NHS premises

• The use of, or potential access to, NHS premises or facilities

• NHS staff – recruited as research participants by virtue of their professional role

(http://www.nres.npsa.nhs.uk/)

Physiotherapy issues

• Aromatherapy oils - unlicensed drugs, need clinical trial exemption certificate (CTX)

• Electrotherapy - refer study to medical devices agency after NRES approval

• If an intervention is likely to take place (e.g., acupuncture), it is the responsibility of the researcher to ensure that the practitioner is competent to undertake such an intervention

http://www.mhra.gov.uk

Session Objectives

What are ethics?

Why are ethics important?

What are the ethical issues I need to consider in my research?

Do I need ethical approval for my research?

From where do I obtain ethics approval?

Ethical Committees

What they consider:

– Validity of the research

– Participant welfare and dignity

MMU Research Ethics Committee

• Aim • Safe practice• Advice for NRES application

• Meet when applications are submitted

• Applications considered by Faculty academics

• Decisions:• accepted• conditional with amendments• rejected

The National Patient Safety Agency National Research Ethics Service

(http://www.nres.npsa.nhs.uk/)

Role: Protection of participants, researcher; allow

high quality, meaningful research

• Lay and professional members

• Monthly meetings

• Online forms – decision within 60 days