class 2 Flashcards
violation of subject rights
scientific misconduct
i.e. fraud, falsifying or fabricating data
NL ethics board
Health Ethics Research Board (HERB)
who serves on an ethics board
researchers, clinicians, lawyers, ethicists, and kay people
function of an ethics board
-protect of rights and welfare
-voluntary informed consent
-benefits exceed risks
how does a research ethics board (REB) determine if a study is fit for ethical approval
-read proposals carefully
-think about procedures
-consider how data is collected
-determine if subjects put at undue risk or rights are violated
-ensure consent contains all necessary elements and is understandable
examples of unethical studies
-nazi medical experiments
-tuskeegee syphilis study
-texas vampires
-texas newborn bloodspot saga
-dr.chandra nutrition studies
-residential school nutrition studies
ellen roche
24 yr old volunteer in an asthma study who died in 2001 because she inhaled hexamethonium a med for high BP in the 50-60s
ethical codes & regulations
-nuremberg code
-declaration of helsinski
-tri-council policy statement: ethical conduct for research involving humans
tri-council policy statement 2: research involving first nations in Canada
-community engagement and collaboration
-indigenous/tradition knowledge
CNA code of ethics for Registered Nurses
-safe, competent, and ethical care
-health and well-being
-choice
-dignity
-confidentiality
-justice
-accountability
-quality practice environment
principles of ethical decision making
-respect for persons (autonomy)
-concern for welfare (beneficence)
-justice
respect for persons (autonomy)
-self-determination
-fully informed, right to withdraw
-no coercion
-fully disclosure, no deception
right to privacy
-anonymity
-confidentiality
-subjects do not have to fully disclose
respect for culture
-respect for continuity for distinct cultures and identities
-respect for traditional/history ways of knowing
-respect for authorities and knowledge holders
principle of beneficence (concern for welfare)
-freedom from harm
study may have:
-no anticipated effects
-temporary discomfort
-unusual levels of temporary discomfort
-risk of permanent damage
-certainty of permanent damage
principle of beneficence (concern for welfare) - freedom from exploitation
-risk/benefit ratios
-high anticipated benefit may balance high risks
principle of beneficence (concern for welfare) - concern for collective welfare (i.e. community)
-consideration of participant environment
-preservation and enhancement of community/environment (e.g. indigenous culture)
-considering indigenous ways of knowing and two-eyed seeing
-must be focused on decolonization reserach ethics
principle of justice
-fair treatment : even if a person chooses not to participate, subject selection, intermediary
-protection from incompetence
-fair representation
special ethical considerations
-old or young
-indigenous peoples
-participants who lack decision-making capacity
-institutionalized persons
-terminally ill
-pregnant women
-students
4 types of informed consent
- essential information for consent
2.comprehension of consent information
3.competency to give consent
4.voluntary consent
elements of informed consent
-statement that this is research
-general purpose of the study and clear description of what the participant is expected to do
-forseeable risks and potential benefits
-alternative to participation
-extent to which privacy will be maintained
-contact information of the researcher
-contact of the relevant REB
-assurance that participation is voluntary and partipants can withdraw at any time without penalty
informed consent
-who signs for whom: consent vs assent
-language
-written vs oral consent
-witneess
ethical issues related to research
-scientific misconduct
-use of animals in research
-fetal tissue research
-genetic research
-privacy protection
