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Ethical Guidelines for Research with Human Participants

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1 Ethical Guidelines for Research with Human Participants
July 2003

2 Guiding Principles Autonomy: respect individual’s right to decide freely whether to participate Beneficence: maximize benefits and minimize harm to participants Justice: 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 Consent Defined: 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 Consent Participants 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 risks Describes the expected benefits (if any) Explains how participant’s confidentiality will be protected Provides name and phone number of person to contact if there are questions/concerns Explains 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 pseudonym Store data in locked file cabinet and/or encrypted in an electronic data file

9 Beneficence Maximize benefits: does the research have scientific merit? Minimize harm to participants: does the research involve risk? What is the risk/benefit ratio?

10 Minimal Risk Defined: 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 death Psychological: emotional disturbance, impairment of cognitive functioning Social: exposure to criminal penalties/litigation, loss of job or social standing

12 Examples of Potential Benefits
Improved physical/mental health of participants and other people Increased scientific understanding of topic under study Participant 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 privileged Researchers must give serious consideration to their subject selection process Who is included? Why? Who is excluded? Why?

14 Recruiting participants
Participation must be truly voluntary—avoid coercion or undue influence Selection 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 participants Composed 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 risks The 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
Autonomy Informed consent Privacy and confidentiality Beneficence: Risk/benefit analysis Scientific merit Justice: Subject selection process

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