Ethical Guidelines for Research with Human Participants
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1 Ethical Guidelines for Research with Human Participants July 2003
2 Guiding PrinciplesAutonomy: respect individual’s right to decide freely whether to participateBeneficence: maximize benefits and minimize harm to participantsJustice: access to participation in research studies must be equitable (e.g., risks should not be borne disproportionately by the disadvantaged)
3 Autonomy Informed Consent Protect participants’ privacy and confidentiality
4 Informed ConsentDefined: voluntary choice of an individual to participate in research based on an accurate understanding of it’s purposes, procedures, risks, benefits, and any other factors that may affect a person’s decision to participate.
5 Informed ConsentParticipants must read and sign an informed consent form prior to their participation in any type of data collection activity.Minor children (under the age of 18) must give assent to participate and a parent/guardian must sign a consent form.
6 Informed Consent Form Describes the research to be conducted Describes the reasonably foreseeable risksDescribes the expected benefits (if any)Explains how participant’s confidentiality will be protectedProvides name and phone number of person to contact if there are questions/concernsExplains the VOLUNTARY nature of the project and the participant’s right to withdraw at any time without penalty.
7 Protect participants’ privacy and confidentiality Is there risk of criminal prosecution or loss of employment if the individual participates in the research project?Is the participant willing to have his/her identity associated with the data provided to the researcher?
8 How to protect privacy and confidentiality of participants Do not ask for the participant’s name or any other identifying information (i.e., keep your data collection anonymous)Remove participant’s name from data after it is collected and assign a number or pseudonymStore data in locked file cabinet and/or encrypted in an electronic data file
9 BeneficenceMaximize benefits: does the research have scientific merit?Minimize harm to participants: does the research involve risk?What is the risk/benefit ratio?
10 Minimal RiskDefined: the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
11 Examples of Potential Risks Physical: bodily injury or deathPsychological: emotional disturbance, impairment of cognitive functioningSocial: exposure to criminal penalties/litigation, loss of job or social standing
12 Examples of Potential Benefits Improved physical/mental health of participants and other peopleIncreased scientific understanding of topic under studyParticipant exposed to state of the art technology
13 Justice Access to participation in research studies must be equitable Historically the risks have been borne disproportionately by the disadvantaged and the benefits realized by the privilegedResearchers must give serious consideration to their subject selection processWho is included? Why?Who is excluded? Why?
14 Recruiting participants Participation must be truly voluntary—avoid coercion or undue influenceSelection must be equitable--is there a scientific reason for excluding non-English speaking participants or is it just more convenient for the researcher?Recruiting from special populations (children, pregnant women, prisoners, mentally handicapped) requires extra safeguards
15 Institution Review Board (IRB) Established at each organization that conducts research with human participantsComposed of faculty members with different backgrounds (some scientific, some not)Reviews applications from researchers who plan to collect data from humans
16 The IRB evaluates proposed research projects by considering: The potential risks to participants and whether the researcher has taken the necessary steps to minimize these risksThe potential benefits to participants and society—do they outweigh the risks?The participant selection process—is it equitable?The completeness and readability of the informed consent form
17 The IRB monitors ongoing research projects Have any undesirable and/or unintended experiences (adverse events) resulted from a subject’s participation in a research study?Is the researcher in compliance with IRB regulations?These regulations are based on Federal laws governing the treatment of human participants in research projects.
18 Review of principles guiding the treatment of research participants AutonomyInformed consentPrivacy and confidentialityBeneficence:Risk/benefit analysisScientific meritJustice:Subject selection process