Institutional Review Board (IRB) Ethics and Informed Consent - PowerPoint PPT Presentation

1 / 21
About This Presentation
Title:

Institutional Review Board (IRB) Ethics and Informed Consent

Description:

Ethics and Informed Consent Marygrove College Resources: Marygrove College IRB Documents http://research.uthscsa.edu/ocr/Privacy and Confidentiality in Human Research.pdf – PowerPoint PPT presentation

Number of Views:417
Avg rating:3.0/5.0
Slides: 22
Provided by: dbro2405
Category:

less

Transcript and Presenter's Notes

Title: Institutional Review Board (IRB) Ethics and Informed Consent


1
Institutional Review Board (IRB)Ethics and
Informed Consent
  • Marygrove College
  • Resources
  • Marygrove College IRB Documents
  • http//research.uthscsa.edu/ocr/Privacy and
    Confidentiality in Human Research.pdf
  • http//www.gifted.uconn.edu/siegle/research/Ethics
    /ethics.htm

2
Overview
  • Introduction Ethics and Classroom Research
  • Definitions
  • 3 Basic Ethical Principles
  • Respect for Persons
  • Beneficence
  • Justice
  • Summary

3
IntroductionEthics and Classroom Research
  • Why are we learning this?
  • It is important to the future of education that
    teachers act as researchers and add to the
    knowledge base of educational research.
  • Researchers are bound by ethics.
  • Researchers connected to an organization that
    collects federal funds must have a way to review
    research for ethical considerations.
  • Some Marygrove students receive federal student
    aid.
  • Therefore, Marygrove MAT - Teacher as Researcher
    students must learn about research ethics and
    conform to federal guidelines.

4
Definitions Code of Ethics
  • Researchers are bound by a code of ethics that
    includes the following protections for subjects
  • Protected from physical or psychological harm
    (including loss of dignity, loss of autonomy, and
    loss of self-esteem)
  • Protection of privacy and confidentiality
  • Protection against unjustifiable deception
  • The subject must give voluntary informed consent
    to participate in research. Parents/Guardians
    must give consent for minors to participate.
    Minors over age 7 must also give their consent to
    participate.

5
Definitions Research
  • Research is a systematic investigation (this
    might range from applying scientific methodology
    involving independent and dependent variables to
    an ethnographic study of a community).
  • It includes research development, testing, and
    evaluation (this also includes pilot studies,
    feasibility studies, and other preliminary
    studies).
  • It is designed to develop or contribute to
    generalizable knowledge (an essential
    consideration is whether it is the intention of
    the investigator to contribute to generalizable
    knowledge).

6
Definitions Human Subjects
  • Living individual(s) about or from whom an
    investigator conducting research obtains
  • Data through intervention or interaction (does
    not need to be face-to-face, could be via email
    or a participant observation) with the individual
    or
  • Identifiable private information (a)
    information about behaviors that occur in a
    context where the individual can reasonably
    expect that no observations or recording is
    taking place, or (b) information that is provided
    for a specific purpose and for which the
    individual can reasonably expect will not be made
    public.

7
DefinitionsPrivacy and Confidentiality
  • Privacy relates to a person. Examples include
    where a person goes, what a person does, who a
    person is with. The research proposal should
    outline strategies to protect privacy, including
    how the investigator will gather data about the
    participants.
  • Confidentiality relates to information/data about
    an individual. This is the agreement between the
    researcher and the participant about how the
    participants identifiable private information
    will be handled, stored, and published. This
    means storing raw data in a secure place, not
    publishing data in which subjects are identified
    by name, encrypting or password protecting
    documents and computers.

8
DefinitionsVoluntary Informed Consent
  • Voluntary informed consent means that the person
    involved
  • Has legal capacity to give consent
  • Is able to exercise free power of choice (no
    fraud, force, deceit, duress, etc.)
  • Has enough knowledge and comprehension of the
    research to make an enlightened decision

9
Definitions Risk
  • Risk is the chance that something bad might
    happen as a result of participating in the
    research.
  • Risk can be physical, mental, or emotional.
  • Risk for those under 18 or in special populations
    is almost always greater than for most adults.

10
3 Basic Ethical Principles
  • Respect for Persons
  • Voluntary Consent
  • Privacy/Extra Protection
  • Beneficence
  • Risk
  • Confidentiality
  • Monitor Data for Safety
  • Justice
  • Subject Selection Equality, Vulnerable
    Populations, Populations of Convenience

11
Respect for PersonsInformed Consent
  • Policy Concerning INFORMED CONSENT
  • In accordance with Federal regulations, College
    policy on research involving human subjects
    requires the use of informed consent forms,
    which must be signed by the subject or the
    legally authorized representative of the subject.
  • The IRB Behavioral Sciences Board is charged with
    the task of reviewing these forms in advance.
    Therefore, each request for the approval of a
    research project should be accompanied by a FINAL
    COPY of a consent form prepared for that project.
  • Only persons whose consent has been obtained in
    the manner indicated can be used as research
    subjects. All signed consent forms must be
    retained by the investigator for a minimum of
    three years. Only IRB approved consent forms may
    be used.
  • If changes are made to a previously approved
    consent form, please notify the IRB
    administrative office. You must have your new
    consent document reviewed and approved before it
    may be used for your subjects (see the Informed
    Consent document for more details).

12
Respect for PersonsPrivacy
  • Privacy Policy Either no identifying
    information is recorded to link a person with the
    data, or if identification is possible, no
    questions are being asked or information being
    collected that could reasonably harm the
    individuals reputation, employability, financial
    standing, or place them at risk for criminal or
    civil liability.
  • Invasion of Privacy This can occur if personal
    information is accessed or collected without the
    subjects knowledge or consent. The subjects
    participation may be revealed without their
    knowledge (e.g., email communications with a
    subject about recovering from sexual assault
    might be read by family members).

13
Respect for PersonsAdditional Protection
  • The regulations also set forth requirements for
    obtaining permission by parents and guardians
    and, except under certain circumstances, assent
    by the children themselves.
  • When the child is a ward of the state, the
    appointment of an advocate is required under some
    circumstances.
  • The regulations exempt from coverage most social,
    economic, and educational research in which the
    only involvement of children as subjects will be
    in one or more of the following categories
  • Research conducted in established or commonly
    accepted educational settings, involving normal
    educational practices
  • Research involving the observation of public
    behavior
  • Research involving the use of educational tests
  • Research involving the collection or study of
    existing data, documents, records, or specimens

14
BeneficenceRisk
  • Risk in an experiment must be minimized.
  • Minimized risk means that the chance and amount
    of harm or discomfort anticipated in the research
    are no greater than what would be encountered in
    regular, daily life.
  • Risks in physical science, like medicine, are
    often easy to see.
  • Risks in social and behavioral science research,
    like that in teacher-research or action research,
    are often more elusive and less predictable.
  • Be especially careful about your communications,
    which can cause unintended risks.

15
BeneficenceReasonable Risk to Benefits
  • Risks to participants must be reasonable in
    relation to the anticipated benefits, if any, to
    the participants and to society and the
    importance of the knowledge that may reasonably
    be expected from the study.
  • Risks, even when unavoidable, can be reduced or
    managed. If there are precautions, safeguards,
    and alternatives that can be incorporated into
    the research activity to reduce the probability
    of harm or limit its severity or duration, the
    IRB will require these changes before approving
    the study.

16
BeneficenceRisk Pre-existing Data Sources
  • Using pre-existing data sources reduces risk to
    subjects
  • Identification of subjects can be done by
    assigning a number to each
  • Examples of pre-existing data sources might
    include number of office referrals or test grades

17
BeneficenceMaintain Confidentiality
  • Confidentiality Researchers must guarantee that
    information related to subjects is kept
    confidential as described in their Informed
    Consent document.
  • Breach of Confidentiality The primary source of
    risk in the social and behavioral sciences is
    that information obtained by researchers could
    harm subjects if disclosed outside the research
    setting.
  • Requirements Researchers must maintain and
    destroy records as stipulated in the federal
    records.
  • Every principal investigator is required by
    federal regulations to maintain records of all
    correspondence relating to the use of human
    subjects in research.
  • These records must be maintained for at least
    three years after the close of the study.
  • After that time, records can be destroyed in such
    a manner as to continue to protect the identity
    of subjects (e.g., shredding documents that
    identify participants).

18
BeneficenceMonitor Data for Subject Safety
  • As you collect data during your research project,
    pay attention to the effect of the study on the
    participants.
  • For example, suppose you are doing a study in
    which you try to reduce bullying. If the
    intervention you try actually makes the bullying
    worse, you should stop immediately and consult
    your mentor.

19
Justice
  • Equal Subject Selection this means making sure
    that if you are selecting only some of your
    students for the intervention, you select those
    students in a way that has nothing to do with
    race, gender, age, etc.
  • A good way to select students equally is a random
    selection method (like every third student on a
    list).

20
Justice (continued)
  • Avoid exploitation of vulnerable populations or
    populations of convenience.
  • Vulnerable populations include those in prison,
    those with special needs, those who are ill, etc.
  • Populations of convenience are groups selected
    because they are handy rather than representative
    of the total population.
  • Use appropriate selection techniques to decide
    who will and who will not be asked to participate
    in the research.

21
Summary
  • As part of the Teacher as Researcher course and
    the Capstone B project, you will file an
    Institutional Review Board (IRB) Application.
  • In filling out the application, you will address
    the basic principles of Respect for Persons,
    Beneficence, and Justice.
  • You will submit your IRB Application to your
    mentor, who will begin the approval process.
  • Once your application has been approved, you will
    be able to begin collecting data.
  • You must maintain private and confidential
    records of your research.
Write a Comment
User Comments (0)
About PowerShow.com