Introducing Research Ethics Flashcards
Research
A structured activity which is intended to provide new knowledge which is generalisable and intended for wider dissemination
What motivates research ethics ?
History of research atrocities - Nazi medical experiments - willowBrook Study - Tuskegee syphilis study ( all research that failed to get consent from participants and participants were put in danger of unnecessary harm )
More recently
- Alder Hay - use and retention of organs from deceased children without the knowledge and consent of parents
- Wakefield (misconduct in study between link of MMR vaccine and autism
Social and moral and political trends
- patient /participant autonomy - (to include them in their care in a study )
- related legislation (human rights act , human tissues act )
- research ethics codes e.g Nuremberg Code ( came from Nazi experiments ) Helsinki declaration (provide guidelines for appropriate research ethics such as need to get consent and not to put people at unnecessary harm
( arises from research atrocities )
Types of research
Human participant versus others ( I.e on animals ) - different as need to get consent and respect autonomy of human participant
Disciplines - research conducted in different Medical areas and non medical areas raise issues which are specific to those disciplines I.e criminology and the issues that might raise on investigating prison populations
Research subjects - give rise to different concerns esp if they are vulnerable groups involved I.e children or mentally ill or reduced capacity individuals
Developing world - area of research that arises within this context
Research ethics principles - governing research
Usefulness - whether it’s likely to discover anything or simply replicating the known
Necessity - research that has to be carried out and carried out on human populations or particular vulnerable groups such as children or mentally ill and can’t be conducted on people who are not vulnerable
Risks - need for risks to be minimised and outweighed by benefits
Consent - from participants before conducting any form of research
Confidentiality - respect confidentiality , personal data that is involved in research
Approval - from research ethics committee
Consent
The getting of permission from a person before involving them in a research project
Important because by getting consent from somebody , you’re respecting that persons autonomy , people less likely to come to harm if they have been consented to take place in research
Involves both need to be informed and to be voluntary
Participant info sheets - ensure Ps have info in order to make a decision whether or not to participate or not
Purpose of study - why is this study taking place ? Why is these particular Ps been chosen to take place ?
What will happen if take part - what is expected from them ?
Risks and benefits of taking part - even if there are minimal benefits of taking part - still need to be stated in the sheet
What if study stops or something goes wrong - what will then happen to the Ps and treatment for example that’s been tested on them
How privacy and confidentiality be respected -
How will they know their info isn’t going to shared publicly
Ethics review - details regarding this are included so Ps can have reassurance that the research has been looked at by a committee of independent people to look for ethics and not just by individual researchers
Voluntary …?
Not putting pressure on patients or volunteers - doctors not pressurising patients to take part in a research study
Not offering inappropriate (financial ) inducements - travel and food costs can be offered but not inducements that would cause them to take risks that they wouldn’t otherwise take
Not threatening / imposing sanctions - that they coerce Ps to taking Part in research
Facilitating consent
Information sheets - very imp - Ps can take sheets away with them and make their decisions in their own time
Presentation of information - technical terms are avoided or explained - set out in a way that is easily understood by a lay person
Summary of key points - in Info sheets but also in discussion with those Ps when consenting them for research
Opportunity to ask questions - particular issues not covered in Ps sheets
Time to decide - atleast 24 hours
Human tissue - governed by human tissues act - state the sort of things that are necessary before tissues can be used
Consent for storage and use of tissue for ‘scheduled purposes ‘ required for tissue from living or deceased persons. These purposes include ‘research in connection with disorders, or the functioning of the human body ‘
Need to get consent from parents where children may not be able to consent or adults in relation to adult tissues
Or even when children are able to consent - parents should be Included in consent procedure
Confidentiality
Not sharing info about a patient /Ps without their expressed consent
Important because by respecting confidentiality we are respecting people autonomy , their right to decide how info about themselves is used also aiding good care - Ps more likely to trust researchers for example if confidentiality is respected . Also info can be used to harm Ps so less risk of that
Guidelines on confidentiality
All Patient info is confidential - anything learned about Ps in course of research project should not be shared with out Ps consent
Research using identifiable personal info or anonymised data from the NHS which is not already in the public domain must be approved by a REC ( research ethics committee )
Coded and anonymised as far as possible
All info to be stored securely - explained to Ps as to how that info will be stored - and only be accessed by those who have a need to access that info in pursuit of their particular research project
Research ethics approval - when is it needed ?
Research involving human participants , human tissue or their personal data
Not needed for research that Dosent involve human participants or any of the above or non clinical purposes such as audit or evaluation
- but difficult to distinguish between clinical research and non clinical purposes
Responsibility of Anybody involved in the research that if needed ethics approval is gained so I.e if a Student involved in research - it is their responsibility to check that any approvals are gained / if I’m doubt seek advice from tutors
Why needed - to protect Ps from harm - a ethics committee is best qualified to make those judgments , researchers are protected and not at risk of harm , minimises claims of negligence , protects integrity and reputation of I.e the NHS and university if it can be demonstrated that ethics approval has been taken , less risk for bad research to take place and hence protecting reputation , often a condition for grant funding or publication - to get a paper published - specify that approval has been obtained , a legal requirement often for some forms of research I. E those who lack mental capacity
From whom - patients / participants (Ps) , relatives or carers of those patients , use of NHS premise / facilities , for access to any organ : data information thru NHS .
Where approval isn’t needed from research ethics committee , it will be needed from the relevant uni department or faculty or university research ethics committee I.e HYMS have a ethics committee from whom approval is needed for research within HYMS
Summary
Research needed for scientific and medical advancement
Research has a history of abuse
Different types of research raise different ethical issues ( and these need to be taken into account by researchers )
Various frameworks and statutory requirements - governing research
Research on humans (/human tissues ) needs REC approval
