*Explain the purpose & role of the IRB *Explain the IRB Review Categories *Discuss the potential risks to research participants

Transcription

1

2 Explain the purpose & role of the IRB Explain the IRB Review Categories Discuss the potential risks to research participants Discuss the informed consent process Review the IRB Submission Process

3 The Institutional Review Board is a committee whose primary responsibility is to protect the rights and welfare of human research participants. All human subjects research conducted at TCSPP is subject to IRB review and approval.

4 Definitions: Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (i.e, archival data, documents, or records, etc.). Research: A systematic investigation, including research development, testing and evaluation designed to contribute generalizable knowledge

5 Exempt Minimal risk and Research must fit within a series of categories as stipulated by federal regulations Reviewed by 1 IRB Member Expedite Full Minimal risk and Research must fit within a series of categories as stipulated by federal regulations Reviewed by 1 IRB Member Greater than minimal risk Reviewed by the entire Committee at a fully convened IRB Meeting

6 Research conducted in established or commonly accepted educational settings, involving normal educational practices such as (1) research on regular and special education instructional strategies, or (2) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research involving the use of educational tests, surveys, interviews or observation of public behavior unless (1) information is recorded in such a manner that the subject can be identified directly or through identifiers; (2) any disclosure of the subjects responses outside the research could place the subject at risk for criminal or civil liability or be damaging to the subjects financial standing, employability or reputation. Research involving the collection or study of existing data, documents, records pathological specimens, or diagnostic specimens if the sources are publically available or if the information is recorded by the investigator in a manner that subjects cannot be identified directly or through identifiers linked to the subjects. Existing data is defined as materials that are on the shelf at the time the research is submitted to the IRB

7 The research poses no greater than minimal risk The identification of the subjects/and or their responses would not reasonably place the subject at risk of criminal or civil liability or be damaging to the subject s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that the risk to privacy and breach of confidentiality are no greater than minimal. The project falls under one of the expedited categories below: Research involving materials (data, documents, records or specimens) that have been collected solely for non-research purposes (such as medical treatment or diagnosis. Collection of data from voice, video, digital or image recordings made for research purposes. Research on an individual or group characteristics or behavior (including but not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

8 Definition: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.

9 Risk of Emotional Harm Depression/upset Shame/Guilt Worry Risk Associated with loss of confidentiality Stigmatization Employability Criminal/Civil Liability

10 Risk of Emotional Harm Screening Debrief participants to evaluate emotional response Provide reference to clinical or therapy services Avoid questions likely to elicit a strong response Avoid using telephone or online data collection Confidentiality Risk Anonymous data collection Share only aggregate data

11 The regulations that govern human subjects research require that informed consent be obtained from every human subject before any research procedures begin.

12 Types of Consent Waiver/Alteration of Consent Minimal risk studies Impracticable to obtain consent Appropriate for retrospective studies using archival data Wavier of Consent Documentation (Oral Consent) Minimal risk studies The only record linking the subject to the research would be the consent document. Appropriate for anonymous survey studies conducted in person or online Written Consent Minimal and more than minimal risk studies Appropriate for studies collecting identifiable information where it is necessary to connect the subject with the data collected.

13 Definition: A process or information exchange that takes place between the prospective subject and the researcher before, during, and sometimes after the study. Informed Consent Process Informative Comprehensible Voluntary

14 Informative Provide a description of study purpose Provide a step-by-step description of the study procedures State risk and benefits Comprehensible Communicated in a language easily understandable to the subject

15 Voluntary choice Free from coercion or undue influence Should state that participation is voluntary Free from language which implies that the participant is being asked to give up rights to which they are entitled. Include appropriate signatures

16 The TCSPP consent form template available on the IRB website must be used to develop your document. Remember that the informed consent document is a legal document and is a reflection of the professionalism of our institution and your expertise as a researcher. This means that documents should be clear, concise, and well written.

17 Visit the IRB website (mychicagoschool academic resources Institutional Review Board) Complete CITI Human Subjects Training Request a User Profile to access the Electronic Submission System Read the instructions in the PI User Guide

18 Include details vague Participants will be recruited by face-to-face contact. Correct grammatical errors Use lay language on all documents, including the Q&A form Explain technical terms (e.g., stimulus preference assessment) Correct Discrepancies Flyer Response in the Q&A form

19 Application reviewed and approved by Dissertation Chair Incomplete response Application Submitted to the IRB Pre-review for completeness Pre-review sent to researcher Complete Response Application sent to IRB Reviewer

20 Research procedures, including recruiting of participants, may not begin until you ve received from the IRB one of the following notices: An Approval Notice An Exemption Notice A Non-Human Subjects Determination Notice

21 IRB Staff Alicia Cook, CIP IRB Director Alicia Scott, MHA Chicago Associate IRB Director Veronica Jimenez, MPH, CIP California Associate IRB Director General mailbox