Institutional Review Board (IRB) Ethics and Informed Consent

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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

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Overview

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

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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.

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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.

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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).

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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.

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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.

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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

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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.

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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

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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).

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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).

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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

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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.

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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.

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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

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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).

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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.

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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).

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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.

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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.