Laura Noll Research Compliance Manager College of Graduate and Professional Studies Radford University, Radford, VA

Brief Overview of the IRB Brief Overview of the IRB Overview of the IRB Website Overview of the IRB Website IRB Review Categories IRB Review Categories Forms Locations Forms Locations IRB Training Requirements IRB Training Requirements Protocol Submission Process Protocol Submission Process Tips and Checklists Tips and Checklists Confidentiality, Anonymity, Privacy, and Confidentiality, Anonymity, Privacy, and De-Identification De-Identification

The Nuremberg Code (Post-WWII) The Nuremberg Code (Post-WWII) Tuskegee Study of Untreated Tuskegee Study of Untreated Syphilis in the Negro Male Syphilis in the Negro Male ( ) ( ) Stanford Prison Stanford Prison Experiment (1971) Experiment (1971) Beecher Report (1966) Beecher Report (1966)

Respect Respect Ensuring that individuals can make informed choices about their participation in research, and protecting those individuals with diminished autonomy Ensuring that individuals can make informed choices about their participation in research, and protecting those individuals with diminished autonomy Beneficence Beneficence Ensuring that the potential risks of a study are minimal, or are justified by the potential benefits Ensuring that the potential risks of a study are minimal, or are justified by the potential benefits Justice Justice Ensuring that the selection of research participants is fair, and not based simply on their easy availability, their willingness to participate, or other considerations not directly related to the problem being studied Ensuring that the selection of research participants is fair, and not based simply on their easy availability, their willingness to participate, or other considerations not directly related to the problem being studied

Federal Definition of “Research”: Federal Definition of “Research”: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

Federal Definition of a “Human Subject”: Federal Definition of a “Human Subject”: A living individual about whom an investigator (whether professional or student) conducting research obtains: A living individual about whom an investigator (whether professional or student) conducting research obtains: Data through intervention or interaction with the individual, or, Data through intervention or interaction with the individual, or, Identifiable private information. Identifiable private information. RU’s definition of whether human subjects are involved may be more stringent in some cases and require greater protection of privacy. RU’s definition of whether human subjects are involved may be more stringent in some cases and require greater protection of privacy. This is determined in the review process. This is determined in the review process.

What is clearly NOT Research? What is clearly NOT Research? Classroom or other programmatic evaluations for the sake of curriculum or other program improvements, but not for use in later publication Classroom or other programmatic evaluations for the sake of curriculum or other program improvements, but not for use in later publication Retrospective studies may be an option for future use of data for publication in some cases. Retrospective studies may be an option for future use of data for publication in some cases. Data collected from students within a class used for demonstration/learning purposes only Data collected from students within a class used for demonstration/learning purposes only Data collected by students purely for the purpose of learning research methodology that will not be published. Data collected by students purely for the purpose of learning research methodology that will not be published.

Inconvenience Inconvenience Physical Risk Physical Risk Psychological Risk Psychological Risk Social Risk Social Risk Economic Risk Economic Risk Legal Risk Legal Risk Types of Participant Risk to Consider:

In short: In short:  It’s federal law  Bottom Line:  Because you have to  If you don’t, you place your institution at risk of federal sanction and the loss of federal funding

Brief Overview of the IRB Brief Overview of the IRB Overview of the IRB Website Overview of the IRB Website IRB Review Categories IRB Review Categories Forms Locations Forms Locations IRB Training Requirements IRB Training Requirements Protocol Submission Process Protocol Submission Process Tips and Checklists Tips and Checklists Confidentiality, Anonymity, Privacy, and De-Identification Confidentiality, Anonymity, Privacy, and De-Identification

Brief Overview of the IRB Brief Overview of the IRB Overview of the IRB Website Overview of the IRB Website IRB Review Categories IRB Review Categories Forms Locations Forms Locations IRB Training Requirements IRB Training Requirements Protocol Submission Process Protocol Submission Process Tips and Checklists Tips and Checklists Confidentiality, Anonymity, Privacy, and De-Identification Confidentiality, Anonymity, Privacy, and De-Identification

Faculty: “Social and Behavioral Research Investigators Basic/Refresher, Basic Course” Students projects involving greater than minimal risk: Same course as Faculty – see above Students projects involving only Minimal Risk projects: “Students conducting no more than minimal risk research”; “Students – Class projects, Basic Course” Tutorials available on RU IRB website to help guide you to the correct courses

Brief Overview of the IRB Brief Overview of the IRB Overview of the IRB Website Overview of the IRB Website IRB Review Categories IRB Review Categories Forms Locations Forms Locations IRB Training Requirements IRB Training Requirements Protocol Submission Process Protocol Submission Process Tips and Checklists Tips and Checklists Confidentiality, Anonymity, Privacy, and De-Identification Confidentiality, Anonymity, Privacy, and De-Identification

Brief Overview of the IRB Brief Overview of the IRB Overview of the IRB Website Overview of the IRB Website IRB Review Categories IRB Review Categories Forms Locations Forms Locations IRB Training Requirements IRB Training Requirements Protocol Submission Process Protocol Submission Process Tips and Checklists Tips and Checklists Confidentiality, Anonymity, Privacy, and De-Identification Confidentiality, Anonymity, Privacy, and De-Identification

Check for completeness and accuracy Check for completeness and accuracy If information is missing, the proposal will be returned. If information is missing, the proposal will be returned. Grammar and spelling MUST be correct on every document that will be seen by participants. Grammar and spelling MUST be correct on every document that will be seen by participants. Consent form must be on RU Letterhead unless provided online. Consent form must be on RU Letterhead unless provided online. Online consents should have RU logo. Online consents should have RU logo. Write at an appropriate reading level for participants Write at an appropriate reading level for participants This is especially important for consent and assent forms. This is especially important for consent and assent forms. Proofread carefully Proofread carefully Avoid discipline-specific jargon Avoid discipline-specific jargon If the proposal can’t be easily understood, the IRB can’t adequately assess it, and your participants can’t provide truly informed consent for their participation. If the proposal can’t be easily understood, the IRB can’t adequately assess it, and your participants can’t provide truly informed consent for their participation.

The IRB Administrator is available to provide IRB presentations to your classes to facilitate the submission process. The IRB Administrator is available to provide IRB presentations to your classes to facilitate the submission process. Please plan ahead when planning courses that include IRB reviews of student submissions. Please plan ahead when planning courses that include IRB reviews of student submissions. IRB reviews take approximately 3-4 weeks for Exempt and Expedited reviews. IRB reviews take approximately 3-4 weeks for Exempt and Expedited reviews. Please allow adequate time for review for semester-based projects. Please allow adequate time for review for semester-based projects. Please contact the IRB Office prior to, or at the time of, submitting semester-based protocols so that we can do our best to facilitate their processing. Please contact the IRB Office prior to, or at the time of, submitting semester-based protocols so that we can do our best to facilitate their processing.

Student Investigators may not be PI. Student Investigators may not be PI. They must share their project in IRBNet with their Faculty Mentor. They must share their project in IRBNet with their Faculty Mentor. The Mentor must electronically “sign” the package prior to submission to indicate their approval of the submission for review by the IRB. The Mentor must electronically “sign” the package prior to submission to indicate their approval of the submission for review by the IRB. Completed Student and Faculty Investigator Agreement forms are to be uploaded to IRBNet. Completed Student and Faculty Investigator Agreement forms are to be uploaded to IRBNet. They no longer need to be sent to the IRB Office in hardcopy with original signature. They no longer need to be sent to the IRB Office in hardcopy with original signature.

It is important that your submission is as complete as possible to minimize lost time in the review process. It is important that your submission is as complete as possible to minimize lost time in the review process. Available resources include: Available resources include: README file, located in the IRBNet Forms Library, addresses elements to be included and final steps to submit a package properly within IRBNet README file, located in the IRBNet Forms Library, addresses elements to be included and final steps to submit a package properly within IRBNet RU IRB New Submission Checklist, in the Resources section of the website Forms page, provides more detail about the flow and content of preparing an IRB submission RU IRB New Submission Checklist, in the Resources section of the website Forms page, provides more detail about the flow and content of preparing an IRB submission

Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others

Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission

Webster defines it as the quality or state of being anonymous: Webster defines it as the quality or state of being anonymous: 1: not named or identified 2: of unknown authorship or origin 3: lacking individuality, distinction, or recognizability Additionally, for IRB purposes, we need to: Additionally, for IRB purposes, we need to: avoid the risk of deductive disclosure or other accidental disclosures by incomplete de-identification, especially in qualitative data avoid the risk of deductive disclosure or other accidental disclosures by incomplete de-identification, especially in qualitative data

Webster threw up its hands at this word Webster threw up its hands at this word It means what it sounds like, the removal of identifying information from the subject’s data It means what it sounds like, the removal of identifying information from the subject’s data However, you must keep in mind the risk of deductive disclosure or other accidental disclosures by incomplete de-identification, especially in qualitative data However, you must keep in mind the risk of deductive disclosure or other accidental disclosures by incomplete de-identification, especially in qualitative data

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