Presentation on theme: "Institutional Review Board (IRB) Ethics and Informed Consent"— Presentation transcript:
1 Institutional Review Board (IRB) Ethics and Informed Consent Marygrove CollegeResources:Marygrove College IRB Documentsand Confidentiality in Human Research.pdf/ethics.htm
2 Overview Introduction: Ethics and Classroom Research Definitions 3 Basic Ethical PrinciplesRespect for PersonsBeneficenceJusticeSummary
3 Introduction: Ethics 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 confidentialityProtection against unjustifiable deceptionThe 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 or a participant observation) with the individual orIdentifiable 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 Definitions: Privacy 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.
8 Definitions: Voluntary Informed Consent Voluntary informed consent means that the person involved:Has legal capacity to give consentIs 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: 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.
10 3 Basic Ethical Principles Respect for PersonsVoluntary ConsentPrivacy/Extra ProtectionBeneficenceRiskConfidentialityMonitor Data for SafetyJusticeSubject Selection Equality, Vulnerable Populations, Populations of Convenience
11 Respect for Persons: Informed Consent Policy Concerning INFORMED CONSENTIn 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).
13 Respect for Persons: Additional 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 practicesResearch involving the observation of public behaviorResearch involving the use of educational testsResearch involving the collection or study of existing data, documents, records, or specimens
14 Beneficence: Risk 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 Beneficence: Reasonable 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 Beneficence: Risk & Pre-existing Data Sources Using 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
17 Beneficence: Maintain 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 Beneficence: Monitor 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 JusticeEqual 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 SummaryAs 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.