In what three scenarios do we need ethical approval?
- Using patients/within NHS: from NHS patients/staff/premises to accessing NHS data
- Requirements under legislation: adults lacking capacity, human tissue, investigating medical drugs/devices etc
- Healthy volunteers: strongly recommended that all research involving healthy volunteers gains ethical approval (for those participating in drug/device trial it is a legal requirement - see (2)
What are the 4 ways in which we differentiate between research, audits and service evaluations?
Research vs audit vs service evaluation:
- derives new knowledge vs. Assesses level of service being provided vs. Judges current care
- addresses clearly defined q’s and aims vs. measures against a standard vs. Measures current service without reference to a standard
- usually involves collecting data vs. Usually involves analysis of existing data vs. Usually involves analysis of existing data
- requires ethical approval vs. Doesn’t require ethical approval vs. Doesn’t require ethical approval
How do we gain ethical approval?
- NHS involvement/legislative requirements = national research ethics committees (RECs) and local NHS R&D approval
- Audits and service evaluations = local NHS audit office
- Healthy volunteers = local ethics committee
(e. g. For students it is he university committee)
What is the mission of the national research ethics service (NRES)?
- To protect the rights, safety, dignity and wellbeing of research participants
- To facilitate and promote ethical research of potential benefit to participants, science and society
What is the role of RECs?
- review applications for research and give opinion about proposed Participant involvement and whether research is ethical
- entirely independent of research sponsors
- give opinion after 35-60 days
What does research on humans include?
- Any direct involvement of patients/healthy volunteers
- Use of clinical data for research
- Use of biological materials for research
- Use of material derived from human tissue (e.g. DNA)
What is the declaration of Helsinki?
- A set of ethical principles for the medical community regarding human experimentation
- developed by the WMA in 1964
- amended multiple times: current version = 2008
What is good clinical practice (GCP)?
An international ethical and scientific quality standard for designing, conducting and reporting trials that involve the participation of human subjects
What does compliance with GCP ensure?
- The rights, safety and wellbeing of subjects are protected
- The trial is consistent with the principles of the Declaration of Helsinki
- Clinical trial data is credible
The EU 2001 directive mandates GCP inspections for all clinical trials involving medicinal products
The NHS research governance framework states that research requires……..?
- Ethical permission
- R&D approval
- Peer review of every proposal
- Clinical trials regulation
- Sponsorship
- Indemnity
- Good research practice and GCP
What are the roles and responsibilities of the research/PI?
- To protect life/health/privacy/dignity
- Research must be justified
- Design of experimental protocol must be rigorous
- Ensure study is performed in accordance with approved protocol
- Maintain complete, accurate and retrievable records
- only enrol appropriate subjects
- ensure subjects are fully informed, volunteer and give valid consent
What is informed consent?
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form
What is different about consenting children under 16?
The consent of a parent or legal representative is required
What are the two types of legal representative for incapacitated adults with regards to giving consent? Provide examples
- Personal: e.g. Guardian with power to consent or adults nearest relative
- Professional: e.g. Doctor responsible for medical treatment or person nominated by healthcare provider
What is ‘equipoise’?
A state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial
What are the three key points of e human tissue act?
- Regulates the removal, storage and use of human tissue
- Creates a new offence of DNA theft - unlawful to use without consent
- Makes it lawful to take minimum steps to preserve organs of a deceased person for use in transplantation while steps are taken to determine the wishes of the deceased
