1. Ethics of research with human volunteers and the College Ethics Review Board

2. القسم الطبي حسب المؤتمر العالمي الأول للطب الإسلامي بسم الله الرحمن الرحيم. أقسم بالله العظيم أن أراقب الله في مهنتي. وأن أصون حياة الإنسان في كافة أدوارها، في كل الظروف والأحوال، باذلًا وسعي في استنقاذها من الموت والمرض والألم والقلق، وأن أحفظ للناس كرامتهم، وأستر عوراتهم، وأكتم سرّهم. وأن أكون على الدوام من وسائل رحمة الله، باذلًا رعايتي الطبية للقريب والبعيد، الصالح والطالح، والصديق والعدو. وأن أثابر على طلب العلم، أسخِّره لنفع الإنسان لا لأذاه. وأن أوقر من علمني، وأعلّم من يصغرني، وأكون أخًا لكل زميل في المهنة الطبية في نطاق البر والتقوى. وأن تكون حياتي مصداق إيماني في سري وعلانيتي، نقيًا مما يشينني أمام الله ورسوله والمؤمنين. والله على ما أقول شهيد

3. Ethical issues in health care ► We usually think of the ‘big’ issues e.g. definition of life, what is a person, quality of life, prolonging life, ending life, human rights. ► But day to day ethical issues can involve:  Respecting people  Treating people with dignity  Treating people fairly  Supporting patient’s choices

4. Ethics is about: ValiditySafetyDignity

5. Validity ► Is this research or audit?  Research is a venture designed to obtain new knowledge that is generalisable. ► Is this a genuine question to which we really do not know the answer? ► Invalid science is not ethical (Where there is an educational objective? ) ► Equipoise in trials: 2 balanced arms where you really do not know which arm is preferable. Therefore randomisation is the only ethical choice. ► Is it statistically sound? Is an expert required?

6. Safety ► Minimal risk must be achieved. ► Is there any danger to participants? ► Are procedures being carried out correctly? ► Are researchers adequately trained? ► Are facilities well managed and safe? ► Does the sponsor have adequate insurance?

7. Dignity ► Are patient’s needs and rights being respected? ► Consent a) to be screened b) to take part ► Confidentiality ► Human beings not human guinea pigs ► Are they from vulnerable groups? ► Do they require renumeration? ► Do they require follow-up? ► ? Compensation? Insurance?

8. Consent ► By definition it is informed ► Do your volunteers have the capacity? ► To make a free decision after weighing up the advantages and disadvantages  Been provided with the information?  Do they comprehend the information?  Do they remember it?  Can they weigh it up?  Can they communicate their intention?

9. How much information should you provide?

10. Consent ► The consent form only provides evidence of consent ► Patient needs to have been given the information and understood it. ► Information sheet should contain as much information as possible about risks that the participant can understand. ► Exception: information may not be given if it would be therapeutically disadvantageous to do so.

11. Providing Information ► Who is your audience? ► Young, old, learning disabled? ► Normal IQ? Reading Age? ► Your volunteers do not have all day! ► Consider getting help from your ASSISTANTS.

12. Providing information (cont’d) ► What is going to happen? ► What are the benefits (self and others)? ► What will be required of me? ► What are the possible risks, costs, benefits? ► Anticipate and relieve anxieties (if appropriate)

13. Providing information cont’d ► Be truthful but do not create anxiety ► Provide an appropriate amount of information for the demands of the experiment. ► Consider pictures and other aids to comprehension

14. What does he or she needs to know? ► What is going to happen in the experiment? ► What are the benefits  For the population in general  For me personally

15. Rewards and coercion ► Should people be paid for participating? ► When does payment mean the decision to participate is no longer free? Could the payment be considered coercive? ► Means of payment:  Reimbursed expenses  Tokens of thanks  Small salary (£5/hr)  (free medical treatment in the U.S.)

16. Payment (cont’d) ► Payment should not be paid for perceived risk. ► Do not state what payment is in advertisement

17. What is an ‘ethical issue’? ► When you have to judge what is right or wrong ► Choosing between options ► Deciding whether to do something or do nothing ► Should I or shouldn’t ? ► Weighing up the potential impact of your decisions or actions ► A dilemma – making a difficult choice

18. 4 Key Ethical Principles ► autonomy ► beneficence ► non-maleficence ► justice

19. Autonomy ► Respect a person’s right to make their own decisions ► Teach people to be able to make their own choices ► Support people in their individual choices ► Do not force or coerce people to do things ► ‘Informed Consent’ is an important outcome of this principle

20. Beneficence (to do good)  Our actions must aim to ‘benefit’ people – health, welfare, comfort, well-being, improve a person’s potential, improve quality of life  ‘Benefit’ should be defined by the person themselves. It’s not what we think that is important.  Act on behalf of ‘vulnerable’ people to protect their rights  Prevent harm  Create a safe and supportive environment  Help people in crises

21. Non – maleficence (to do no harm) ► do not to inflict harm on people ► do not cause pain or suffering ► do not incapacitate ► do not cause offence ► do not deprive people ► do not kill ► Both Beneficence and Non-maleficence underpin EBP

22. Justice ► Treating people fairly ► Not favouring some individuals/groups over others ► Acting in a non–discriminatory / non-prejudicial way ► Respect for peoples rights ► Respect for the law

23. Justice Distributive Justice – sharing the scarce resources in society in a fair and just manner (e.g. health services, professional time)  How should we share out healthcare resources?  How do we share out our time with patients?  Deciding how to do this raises some difficult questions Patients should get…..  an equal share ?  just enough to meet their needs ?  what they deserve ?  what they can pay for ?

24. 4 ethical rules ► Veracity – truth telling, informed consent, respect for autonomy ► Privacy – a persons right to remain private, to not disclose information ► Confidentiality – only sharing private information on a ‘need to know basis’ ► Fidelity – loyalty, maintaining the duty to care for all no matter who they are or what they may have done