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

OverviewOverviewIntroduction: Ethics and

Classroom ResearchDefinitions3 Basic Ethical Principles

◦Respect for Persons◦Beneficence◦Justice

Summary

Introduction:Introduction:Ethics and Classroom Ethics and Classroom ResearchResearch

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.

Definitions: Code of EthicsDefinitions: Code of EthicsResearchers are bound by a code of ethics that

includes the following protections for subjects: 1.Protected from physical or psychological

harm (including loss of dignity, loss of autonomy, and loss of self-esteem)

2.Protection of privacy and confidentiality 3.Protection against unjustifiable

deception 4.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.

Definitions: ResearchDefinitions: 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). o It includes research development,

testing, and evaluation (this also includes pilot studies, feasibility studies, and other preliminary studies).

o 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).

Definitions: Human SubjectsDefinitions: Human SubjectsLiving 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.

Definitions:Definitions:Privacy and ConfidentialityPrivacy 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 participant’s 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.

Definitions:Definitions:Voluntary Informed ConsentVoluntary 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

Definitions: RiskDefinitions: RiskRisk 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.

3 Basic Ethical Principles3 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

Respect for Persons:Respect for Persons:Informed ConsentInformed 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).

Respect for Persons:Respect for Persons:PrivacyPrivacy 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 individual’s 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 subject’s knowledge or consent. The subject’s 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).

Respect for Persons:Respect for Persons:Additional ProtectionAdditional 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

Beneficence:Beneficence:RiskRiskRisk 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.

Beneficence:Beneficence:Reasonable Risk to BenefitsReasonable Risk to BenefitsRisks 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.

Beneficence:Beneficence:Risk & Pre-existing Data Risk & Pre-existing Data SourcesSourcesUsing pre-existing data sources

reduces risk to subjectsIdentification of subjects can be

done by assigning a number to eachExamples of pre-existing data

sources might include number of office referrals or test grades

Beneficence:Beneficence:Maintain ConfidentialityMaintain 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).

Beneficence:Beneficence:Monitor Data for Subject Monitor Data for Subject SafetySafetyAs 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.

JusticeJusticeEqual 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).

Justice Justice (continued)(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.

SummarySummaryAs 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.