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Ethical Guidelines for Research with Human Participants by NIQe3C


									Ethical Guidelines for
Research with Human
       July 2003
        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
Informed Consent
Protect participants’ privacy and
        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.
      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
  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.
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?
 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
Maximize benefits: does the research
have scientific merit?
Minimize harm to participants: does the
research involve risk?
What is the risk/benefit ratio?
          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
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
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
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?
    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
Institution Review Board (IRB)
 Established at each organization that
 conducts research with human
 Composed of faculty members with
 different backgrounds (some scientific,
 some not)
 Reviews applications from researchers
 who plan to collect data from humans
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
 The completeness and readability of the
 informed consent form
 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.
   Review of principles guiding the
  treatment of research participants
  Informed consent
  Privacy and confidentiality
  Risk/benefit analysis
  Scientific merit
  Subject selection process

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