Introduction to Research Ethics Flashcards
Why ethics?
- Ethics is about values and norms (‘how we should live life’)
- Healthcare is a ‘value driven’ practice. so healthcare and ethics have long been associated
- research in the life scenes raises particular ethical concerns which scientists need to understand
- healthcare practice raises distinct ethical concerns which healthcare professionals need to understand
- these concerns are now recognised internationally, and most countries have mechanisms in place to ensure they are addressed
Why do we need research ethics?
- it enables better healthcare
- knowledge is an intrinsic good (even if we on’t know what we will do with it
- in hierarchical organisations there is a heightened propensity for unacceptable behaviour and processes
- out o respect for authority people will consent to or participate in things that are unacceptably harmful (can’t rely on peoples conscience and choice to ensure people are sufficiently safe)
The problem is when research is done unethically.
- unethical research has shown that people will do things that will make themselves and others uncomfortable when an authority figure tells them to (so individual informed consent is not enough)
- and that peoples decisions are swayed by what people around them are doing/saying
What are the National Ethics Advisory Committee principles?
Te Ara Tika Principles:
- Tika, Manaakitanga, whakapapa, mana
Bioethics principles:
- beneficence, non-maleficence, respect for people, justice
What are the key considerations of research ethics committees?
- assess the benefits and harms and ensure the ratio is acceptable (links to beneficence and non-maleficence)
- be aware of potential vulnerabilities of participants (links to all the principles)
- avoid to manage conflict of interest (links to respect for persons and justice)
- Obtain informed consent from participants (links to respect for persons)
- consider how the benefits and burdens of the research should be shared across society (links to justice)
define beneficence and non-maledicence
- beneficence (the duty we have to help people): refers to the obligations that we have to ‘benefit’ others. in research it is the obligation to ensure that the research is generating something of value that justifies the costs
- non-maleficence (the duty we have to not unnecessarily harm someone): refers to the obligation that we have not to harm others without a justifying reason. in research this means being aware of the various potential harms to participants and others, and either taking steps to avoid these or ensuring that the benefits are sufficient to justify the harms
what are the general policies for balancing benefits and harms?
- an awareness of the various costs or harms to participants including time, resources, coercive factors, and any opportunity costs (inlcuding other treatments)
- strategies to address these harms or costs
- an awareness of potential cultural sensitivities or interests, including (in NZ) the implications for Māori
- evidence of the scientific validity of the research
what is clinical equipoise and some issues with it?
clinical equipoise is the requirement that researchers only provide an experimental treatment if the evidence for the experimental treatment is equal to that available for the standard treatment (have to have a genuine not sure if its good or not)
- the idea that the participant should not suffer any substantial disadvantage from being in the study
- there can be disagreement about when evidence is ‘equally poised’
- there can be debate about which ‘standard treatment’ the intervention should be compared to
describe the ethical factor of being aware of potential vulnerabilities of participants
A vulnerable person is any person who is more at risk of exploitation, because social or physical disadvantages.
- people who are financially worse off
- those subject to racial or religious disicrimination
- people who are less educated
- those suffering cognitive impairments
- older people
- prisoners
- children
- people who are ill (patients)
- research involving vulnerable people needs to include measures to protect those people from exploitation. ethics committees will normally not permit researchers to do anything that may take advantage of the participants vulnerability
- has some topics which are up for debate (high pay, pregnant women, unconscious people, cancer treatment that is unproven but the person is dying alr)
describe the ethical factor of conflicts of interest
A conflict of interest is a situation where a person holds two or more potentially incompatible interests. These are of concern in research where researcher(s) have interest that might compromise the values and standards of ethically appropriate research
Conflict of interest can arise in research in various ways:
- professionally, academically, financially, politically
Conflicts of interest can e managed in various ways, such through peer review, blinding, open access to data, auditing and using independent people to recruit participants
Nevertheless, such conflict appear to be an increasing threat to the integrity of research
describe the ethical factor of informed consent
informed consent is ordinarily required when participants are enrolled in research studies
adequately informed consent requires:
- disclosure of the purpose, risks and processes of the study
- reasonable efforts form the researcher to explain this information
- that th person is competent to give consent
- the absence of any coercive factors (including financial inducements)
- consent for research must be in writing (verbal consent is sufficient for most treatments)
- there is debate about whether and under what condition people who are not competent to consent should be included in research
- all studies will have an information sheet and consent process for all participants. however, the process doesn’t end once the form is signed; it should be ongoing
describe the ethical factor of justice
justice requires:
- transparency
- that all people are considered of equal worth
- that effort are made to make society equitable
Applied to research this means:
- whip a population, there should be a fair distribution of the benefits and burdens of participation in a study. investigators must avoid an unfair burden of participation on particular groups
- studies should be designed so that the inclusion and exclusion conditions for paricipants are fair. people should not be excluded on the basis of sex, sexuality, ethnicity, national origin, religion, education or socioeconomic status, except where such exclusion or inclusion is essential to the purposes of the study
- funders and researchers should support and design research that could help reduce inequity
Describe the view processes in NZ
Ethics committees in NZ:
- the ministry of health administers 4 health and disability ethics committees for oversight of health research
- and also: advisory committee on assisted reproductive technologies (ACART) and ethics committee on assisted reporudctuce technologies (ECART)
- research institutions (such as the university of Otago) have their own committees
What needs ethical review in NZ?
- any health and disability research investigation that involves human participants; that compares and established procedure with other procedures that are not recognised as established.
- an innovative procedure = planned deviation from the currently accepted practice of NS body of health professionals involving an untested or unproved clinical intervention intended to be used on an ongoing basis
- in general, it’s not required for auditing, some surveys (eg. patient satisfaction surveys), using publicly accessible databases
What enforces ethical review in NZ?
- prerequisite for funding public funding (HRC)
- prerequisite for publication in major health journals
- clinical trials registry
- professional obligation: hospital and university disciplinary procedures for breaching research ethics standards
