Final 480 Research

Review of public health information.  

28 cards   |   Total Attempts: 188
  

Cards In This Set

Front Back
What is Beneficience?
The study that one should do good. it is beleived that individual participatns and the communites from whic hthey are drawn should benefit
Nomalecence
The study should not do harm
Autonomy
Participation in research should be completely voluntary. Each potential participant should be fully informed about the benefits and burden of the disease, the procedures involved, the plan for use and the data collected, given a free choice to participate or not. respect for persons is a broader concept that includes,for example just justifying the necessiy for the research project. choosing an appropriate source population, using a fair process to sample and recruit particiaptns, ensuring an adequate sample size, making research procedures minimally invasive, maintaining the confidentialtiy of study data.
What is distributive justice
When they ensure the benefits and burdens of research are equitable
What are incentives?
Research need to consider the the etnical implications such as inducement to potential participants to encourage them to study, reimbursement for the cost of the participation, compensation for their time and effort, participation in a research project should not undue burden to participants, they should be balanced for the need for voluntary participation.
When would the principle of voluntariness be violated on an individual?
When an individual feels coerced into participation, it can include social pressure or requests from authority figures, it can also include overly generous incentives, researchers need to be transparent about what participants will gain and what they will not gain.
What are informed consent statements?
They provide essential information about research to potential research participants so that they can make a reasoned decision whether to enroll in a study. The statement should use clear, simple language that the reader is able to understand.
What are steps involved in the informed consent process?
It consists of reading the informed consent statement to a potential participant and allowing the individial to rad a copy of the statement. It then allows an adequate time for the potential participant to consider whether he or she wants to participate, answer any questions, only then asking whether the individual is willing to sign an informed consent form
What is confidentiality and privacy?
Privacy is the assurance that individuals have the right to choose what information they reveal about themselves. Confidentiality is the protection of personal information provided to researchers. When possible, do not colect any personally identifiable information. Researchers asking questions about sesnitve issues must decide ahead of time how to handle disclosures.
What steps must you do when including members of vul. populations in a study?
A legally approved guardian is allowed to grant consent on behalf of the study particpant. In addition to legal represenatative consent, potential particants should assent to their own participation.
What are the three primary goals of research ethics committes or Institutional review Boards?
To protect the "human subjects" who partiipate in research studies. To legally protect the researcher's instituion from the liability that could occur as a result of research activities. To protect researchers by preventing them from enganging in activites that could cause harm. the major function os ethics review board are to, review new and revised research protocols, approve or disapprove of those protocols, ensure that informed consent is documented, and condicut contining review of long term research proects.
What are three possible steps that can happen once application materials have been submitted?
Exemption, expedited review, full review, the ethics review board decides which action is appropiate
When a review board grants an exemption, what does it entail?
The research involves the analysis of existing records or existing biological specimens that cannot be linked to individuals, data will be collected as part of routine practice actvities and are not intended to contribute to generalizable knowledge.
What is a full review of a research proposal usually requrired?
When data will be collected through interaction with individuals, an intervention will be tested in individal or a community, identifiable private information will be collected
What is an ongoing review
When ongoing research protcols must be re-reviewed annually( or more often, the discretion of the ethics review committe)