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A revision of previous PowerPoint Presentations for classes, to serve as a supplement to information provided by the Office of Human Research Ethics at.

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Presentation on theme: "A revision of previous PowerPoint Presentations for classes, to serve as a supplement to information provided by the Office of Human Research Ethics at."— Presentation transcript:

1 A revision of previous PowerPoint Presentations for classes, to serve as a supplement to information provided by the Office of Human Research Ethics at UNC-Chapel Hill Barbara Davis Goldman, PhD Previously pre-IRB Review Consultant UNC-Chapel Hill School of Education Navigating the IRB Process for School of Education Students & Faculty

2 Overview of Content Overview of policies (federal and local), procedures, ethical principles, and UNC IRB forms (slides 3-23) Overview of policies (federal and local), procedures, ethical principles, and UNC IRB forms (slides 3-23) Ethical principles of Belmont Report in practice (24-35) Ethical principles of Belmont Report in practice (24-35) Additional issues involved when conducting research in schools (slides 36-46) Additional issues involved when conducting research in schools (slides 36-46) FERPA FERPA PPRA PPRA Preliminary contact to determine feasibility and learn local procedures (soft scopes) Preliminary contact to determine feasibility and learn local procedures (soft scopes) Dual roles: teacher & researcher (2-hat problem) Dual roles: teacher & researcher (2-hat problem) NOTE—this is supplementary material—consult the online guidance of UNC’s Office of Human Research Ethics for up-to-date information BDG for SoE

3 Protecting Research Subjects Multiple sources of motivation for IRBs Multiple sources of motivation for IRBs Negative examples from history (featured in CITI training, and almost all introductory presentations) Negative examples from history (featured in CITI training, and almost all introductory presentations) Positive principles—embodied in the Belmont Report Positive principles—embodied in the Belmont Report Multiple sources of governance of IRBs Multiple sources of governance of IRBs Regulated by US law—45 CFR 46 (Code of Federal Regulations: “the regs”) Regulated by US law—45 CFR 46 (Code of Federal Regulations: “the regs”) Guided by interpretations from the federal Office for Human Research Protections (OHRP) Guided by interpretations from the federal Office for Human Research Protections (OHRP) Governed locally by the IRBs, with their own “standard operating procedures” and traditions—at UNC-Chapel Hill, that includes the Office of Human Research Ethics or OHRE, as the overall administrative organization Governed locally by the IRBs, with their own “standard operating procedures” and traditions—at UNC-Chapel Hill, that includes the Office of Human Research Ethics or OHRE, as the overall administrative organization BDG for SoE

4 Code of Federal Regulations Title 45 Part 46 (45 CFR 46) Defines “research” and “human subjects” Defines “research” and “human subjects” Describes special procedures for “vulnerable populations” Describes special procedures for “vulnerable populations” Describes Describes what needs to be reviewed and approved what needs to be reviewed and approved what can be exempted from review, OR reviewed and exempted from further review what can be exempted from review, OR reviewed and exempted from further review what does NOT need review what does NOT need review Describes requirements for obtaining informed consent, and requirements for waiving consent or its documentation Describes requirements for obtaining informed consent, and requirements for waiving consent or its documentation Mandates the existence of an IRB and specifies its composition and structure Mandates the existence of an IRB and specifies its composition and structure BDG for SoE

5 IRB APPROVAL is only required if the activity meets the definition of “human subjects research” “Research” is defined by the federal guidelines as “as systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” “Research” is defined by the federal guidelines as “as systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” [45 CFR (d)] A “human subject” is defined by the federal regulations as a “living individual about whom an investigator conducting research obtains A “human subject” is defined by the federal regulations as a “living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (1) data through intervention or interaction with the individual, or (2) “identifiable private information” [45 CFR (f)] (2) “identifiable private information” [45 CFR (f)] BDG for SoE

6 Belmont Report The Belmont Report provides conceptual guidance about ethics to: The Belmont Report provides conceptual guidance about ethics to: the IRB members who review research studies, the IRB members who review research studies, the researchers (and the STUDENT RESEARCHERS) who propose them, and the researchers (and the STUDENT RESEARCHERS) who propose them, and the students interacting with persons in a research-like manner doing class projects or practica the students interacting with persons in a research-like manner doing class projects or practica The 3 ethical principles of the Belmont Report: The 3 ethical principles of the Belmont Report: Respect for persons Respect for persons Beneficience Beneficience Justice Justice How the principles play out in research is in the second part of this PowerPoint (slides 24-35) How the principles play out in research is in the second part of this PowerPoint (slides 24-35) BDG for SoE

7 Office for Human Research Protections (OHRP) Part of the federal Health and Human Services (HHS)— governs IRBs Part of the federal Health and Human Services (HHS)— governs IRBs Responsible for ensuring the safety and welfare of the people who participate in HHS-sponsored research Responsible for ensuring the safety and welfare of the people who participate in HHS-sponsored research OHRP has formal agreements, or “assurances” with > 4000 institutions that they will conform to 45 CFR 46 and OHRP guidance OHRP has formal agreements, or “assurances” with > 4000 institutions that they will conform to 45 CFR 46 and OHRP guidance Some institutions agree to apply “the regs” to ALL research, not just federally funded work, but most do not—institutions can also decide to apply the “Common Rule,” known as Subpart A, but not the other 3 subparts (B, C, D) Some institutions agree to apply “the regs” to ALL research, not just federally funded work, but most do not—institutions can also decide to apply the “Common Rule,” known as Subpart A, but not the other 3 subparts (B, C, D) NOTE: 45 CRF 46, Subpart A (the Common Rule) limits what research can be considered “exempt” from the regulations when the research involves children NOTE: 45 CRF 46, Subpart A (the Common Rule) limits what research can be considered “exempt” from the regulations when the research involves children BDG for SoE

8 IRB Overview at UNC-Chapel Hill The purpose of the Institutional Review Board (IRB) is to review RESEARCH protocols that involve human subjects to HELP RESEARCHERS ensure ethical treatment The purpose of the Institutional Review Board (IRB) is to review RESEARCH protocols that involve human subjects to HELP RESEARCHERS ensure ethical treatment There are now only 2 IRBs on UNC-Chapel Hill campus—the Biomed IRB (4 separate boards) and the NON-Biomed IRB (a recent combination of the previous Behavioral IRB and Public Health-Nursing IRB). All are under the larger umbrella of the UNC-CH Office of Human Research Ethics (OHRE) There are now only 2 IRBs on UNC-Chapel Hill campus—the Biomed IRB (4 separate boards) and the NON-Biomed IRB (a recent combination of the previous Behavioral IRB and Public Health-Nursing IRB). All are under the larger umbrella of the UNC-CH Office of Human Research Ethics (OHRE) Who's on the IRB? Faculty, students, community member, prisoner advocate, non-scientist (a non-scientist and quorum must be present at a full board meeting ). Who's on the IRB? Faculty, students, community member, prisoner advocate, non-scientist (a non-scientist and quorum must be present at a full board meeting ). However, almost all SoE studies are eligible for “expedited review” rather than “full board review” so they are generally reviewed by an IRB coordinator and an IRB Chair However, almost all SoE studies are eligible for “expedited review” rather than “full board review” so they are generally reviewed by an IRB coordinator and an IRB Chair BDG for SoE

9 IRB Overview at UNC-Chapel Hill NOTE: some UNC Institutes (e.g., FPG), Departments (e.g., Psychology) and Schools (e.g., Social Work, Education) that feed into the NON-Biomedical IRB offer “pre-IRB local, departmental review” to help researchers navigate the IRB process as well as providing the required departmental review NOTE: some UNC Institutes (e.g., FPG), Departments (e.g., Psychology) and Schools (e.g., Social Work, Education) that feed into the NON-Biomedical IRB offer “pre-IRB local, departmental review” to help researchers navigate the IRB process as well as providing the required departmental review The level of assistance provided is entirely up to the local department The level of assistance provided is entirely up to the local department IRB approval is required before any contact is made with RESEARCH subjects, whether contact is for recruitment or data collection IRB approval is required before any contact is made with RESEARCH subjects, whether contact is for recruitment or data collection IRB approval is required before secondary analyses that are considered to be “human subjects research” are begun, BUT not all secondary analyses need IRB approval in advance—it depends on their purpose, who is conducting them, and the identifiability of the data IRB approval is required before secondary analyses that are considered to be “human subjects research” are begun, BUT not all secondary analyses need IRB approval in advance—it depends on their purpose, who is conducting them, and the identifiability of the data BDG for SoE

10 START HERE See the OHRE website at : See the OHRE website at :http://ohre.unc.edu Provides news and updates—currently information about requirements for naming all attachments including consent documents Provides news and updates—currently information about requirements for naming all attachments including consent documents GO TO For Researchers For Researchers Submission Instructions READ this section Submission Instructions READ this section FAQ—very big; REVIEW the 1 st section, DETERMINE WHETHER IRB REVIEW IS REQUIRED, including “What about student research and class projects” FAQ—very big; REVIEW the 1 st section, DETERMINE WHETHER IRB REVIEW IS REQUIRED, including “What about student research and class projects” Ethics Training (for access to the CITI online training and UNC ethics training database)--CONSULT Ethics Training (for access to the CITI online training and UNC ethics training database)--CONSULT Dates & Deadlines (generally NOT an issue) Dates & Deadlines (generally NOT an issue) How do I apply How do I apply NOTE—”loading” can often take a fair amount of time in-between actions NOTE—”loading” can often take a fair amount of time in-between actions BDG for SoE

11 Types of student activities & IRB involvement There are 3 major types of activities that students could carry out that are, or resemble, research: There are 3 major types of activities that students could carry out that are, or resemble, research: l Working on a RESEARCH project as a research assistant that is headed by a faculty member or other principal investigator l Generally, a student RA needs only CITI online ethics training; PI asks the IRB to add the student to the study’s roster l Conducting a CLASS PROJECT or fulfilling a PRACTICUM assignment for educational purposes l Generally, NO interaction with the IRB needed, except in certain circumstances l Carrying out student RESEARCH activities such as masters theses or projects, or doctoral dissertations, as part of a degree program l Need to submit an application—depending on responses to early screening questions, your work may be considered to be “Not Human Subjects Research” (NHSR) OR as HSR but eligible for exemption from extensive review BDG for SoE

12 Student Research & Class Projects/Practica Students are special—OHRE provided explicit NEW guidance for students in the spring of 2006, which was revised slightly in the spring of 2007 and revised slightly twice in 2008—most current “official” version is dated Students are special—OHRE provided explicit NEW guidance for students in the spring of 2006, which was revised slightly in the spring of 2007 and revised slightly twice in 2008—most current “official” version is dated Guidance focuses on the differentiation between work that may “look like” research, but is done for practica or class projects, and “real” student research, for undergraduate honors theses, masters papers & theses, and dissertations, as well as additional research intended for publication Guidance focuses on the differentiation between work that may “look like” research, but is done for practica or class projects, and “real” student research, for undergraduate honors theses, masters papers & theses, and dissertations, as well as additional research intended for publication BDG for SoE

13 Class projects and practica Most class projects and practica are conducted for educational purposes, not as “research,” and will NOT need IRB approval, with some exceptions: Most class projects and practica are conducted for educational purposes, not as “research,” and will NOT need IRB approval, with some exceptions: If you plan to use secondary data that includes Protected Health Information (PHI) If you plan to use secondary data that includes Protected Health Information (PHI) If your work involves direct interaction AND is intended to be both an educational experience AND you intend to present this activity AS RESEARCH or as “generalizable knowledge” TO OTHERS (which doesn’t mean when it is presented as a class project to others, which is the more common situation) If your work involves direct interaction AND is intended to be both an educational experience AND you intend to present this activity AS RESEARCH or as “generalizable knowledge” TO OTHERS (which doesn’t mean when it is presented as a class project to others, which is the more common situation) BDG for SoE

14 Even if your interaction is not “research” because it is a class project, ethical guidelines still apply The Belmont Report provides conceptual guidance to researchers, and to those interacting with persons in a research-like manner doing class projects or practica The Belmont Report provides conceptual guidance to researchers, and to those interacting with persons in a research-like manner doing class projects or practica Faculty member will provide specific guidance Faculty member will provide specific guidance The 3 ethical principles of the Belmont Report: The 3 ethical principles of the Belmont Report: Respect for persons Respect for persons Beneficience Beneficience Justice Justice You will need to consider this in more detail if and when you choose to do class projects that involve direct interaction---SEE slides You will need to consider this in more detail if and when you choose to do class projects that involve direct interaction---SEE slides BDG for SoE

15 Student Research Guidance Overview Student RESEARCH includes undergraduate honors theses; masters papers, theses and projects; dissertations; and comparable activities Student RESEARCH includes undergraduate honors theses; masters papers, theses and projects; dissertations; and comparable activities Application for IRB APPROVAL is generally required if there is direct interaction with human subjects Application for IRB APPROVAL is generally required if there is direct interaction with human subjects Application for IRB APPROVAL is generally required for secondary analyses if the researchers have access to identifiers or PHI, or in other special circumstances Application for IRB APPROVAL is generally required for secondary analyses if the researchers have access to identifiers or PHI, or in other special circumstances Student RESEARCH involving ONLY secondary analysis of publicly available, de-identified, or “coded” data where the student will not have access to identifiers does NOT require approval, but an application MAY need to be submitted to document its status as “not human subjects research.” Most likely you will primarily be responding to screening questions and some description that will formally document the status as “NHSR” which does not need IRB approval Student RESEARCH involving ONLY secondary analysis of publicly available, de-identified, or “coded” data where the student will not have access to identifiers does NOT require approval, but an application MAY need to be submitted to document its status as “not human subjects research.” Most likely you will primarily be responding to screening questions and some description that will formally document the status as “NHSR” which does not need IRB approval BDG for SoE

16 Student Research cont. SEE OHRE Student Guidance Handout and BDG’s HANDOUT “Gloss” to explain in more detail the OPTIONS now available for IRB APPROVAL of student research SEE OHRE Student Guidance Handout and BDG’s HANDOUT “Gloss” to explain in more detail the OPTIONS now available for IRB APPROVAL of student research NOTE: NOTE: Student researcher and faculty advisor MUST have current ethics training to submit an application for IRB approval—CITI online training (Basic, Group 2 Social Behavioral) Student researcher and faculty advisor MUST have current ethics training to submit an application for IRB approval—CITI online training (Basic, Group 2 Social Behavioral) Everyone else on the research team with access to identifiable information or in contact with participants needs to be ethics-trained too BUT not all need to be listed now in the online form (change from the past) Everyone else on the research team with access to identifiable information or in contact with participants needs to be ethics-trained too BUT not all need to be listed now in the online form (change from the past) Ethics training should NOT be required by the IRB if your work is considered “Not Human Subjects Research” which simply receives a “determination” from the IRB, not approval, but CITI research ethics training may be required by the faculty advisor Ethics training should NOT be required by the IRB if your work is considered “Not Human Subjects Research” which simply receives a “determination” from the IRB, not approval, but CITI research ethics training may be required by the faculty advisor BDG for SoE

17 Secondary data issues continued Some activities that ARE research, but are NOW not considered to be “human subjects research” do NOT need approval by the IRB Some activities that ARE research, but are NOW not considered to be “human subjects research” do NOT need approval by the IRB This 2006 policy brought UNC-CH more in line with federal (OHRP) policy (August 10, 2004; updated October 16,2008) about the handling of secondary analyses of de-identified or of CODED data or specimens, AND to deal with other “not human subjects research” scenarios—this was a BIG change This 2006 policy brought UNC-CH more in line with federal (OHRP) policy (August 10, 2004; updated October 16,2008) about the handling of secondary analyses of de-identified or of CODED data or specimens, AND to deal with other “not human subjects research” scenarios—this was a BIG change STUDENTS--Be aware that the process for determining that work is “NHSR” online may be unfamiliar to some faculty advisors STUDENTS--Be aware that the process for determining that work is “NHSR” online may be unfamiliar to some faculty advisors BDG for SoE

18 Secondary data issues cont. Your secondary data analyses for research purposes may be determined to be NHSR, and not need formal approval IF: Your secondary data analyses for research purposes may be determined to be NHSR, and not need formal approval IF: the identifying information is NOT available to the researcher, because the data/records or specimens are de-identified, or there never were identifiers, OR the identifying information is NOT available to the researcher, because the data/records or specimens are de-identified, or there never were identifiers, OR the data have a CODED identifier, and the researcher will not have access to the code, by formal agreement, OR the data have a CODED identifier, and the researcher will not have access to the code, by formal agreement, OR the data are publicly available the data are publicly available BDG for SoE

19 Secondary data issues EXCEPTION—cannot consider the research to NOT involve human subjects if the data are protected by HIPAA (if the data come DIRECTLY from a health plan, health care clearinghouse, or health care provider) EXCEPTION—cannot consider the research to NOT involve human subjects if the data are protected by HIPAA (if the data come DIRECTLY from a health plan, health care clearinghouse, or health care provider) If the data are protected by HIPAA, the researcher needs to submit an IRB application to get a WAIVER of HIPAA authorization If the data are protected by HIPAA, the researcher needs to submit an IRB application to get a WAIVER of HIPAA authorization EXCEPTION—if the data belong to the student’s faculty advisor/mentor who has access to the identifiers, or someone who will be listed as an author of a publication from this work has a list linking identity to ID codes, then that work is considered to be HSR, and requires the complete application and approval, focusing on the data, and requesting a waiver of consent, EVEN IF the student does not have access to identifiers EXCEPTION—if the data belong to the student’s faculty advisor/mentor who has access to the identifiers, or someone who will be listed as an author of a publication from this work has a list linking identity to ID codes, then that work is considered to be HSR, and requires the complete application and approval, focusing on the data, and requesting a waiver of consent, EVEN IF the student does not have access to identifiers. BDG for SoE

20 Miscellaneous Approval Matters IRB approval is for one year (and occasionally less) and in general must be renewed for continued research activity, including analysis of identifiable data and publication, for as long as you are a student at the university IRB approval is for one year (and occasionally less) and in general must be renewed for continued research activity, including analysis of identifiable data and publication, for as long as you are a student at the university Any changes, anticipated or unanticipated, to the protocol must be approved as “modifications” prior to implementation Any changes, anticipated or unanticipated, to the protocol must be approved as “modifications” prior to implementation MODIFICATIONS also allow the researcher to apply for approval as the research develops — you don’t have to know absolutely everything in advance, but say so if something you mention in the application will be submitted later, so the IRB doesn’t think it’s “missing” MODIFICATIONS also allow the researcher to apply for approval as the research develops — you don’t have to know absolutely everything in advance, but say so if something you mention in the application will be submitted later, so the IRB doesn’t think it’s “missing” All documents and procedures used with subjects must be approved—so researchers MUST submit MODIFICATIONS for those changes and obtain approval before they are instituted All documents and procedures used with subjects must be approved—so researchers MUST submit MODIFICATIONS for those changes and obtain approval before they are instituted BDG for SoE

21 Applying for IRB Approval for Research Involving Direct Interaction or Identifiable Data Application in “Online Submission” at Application in “Online Submission” at Informed consent/parent permission/assent/fact sheets will be constructed within the program. Specific forms will be required based on how you responded to various questions. You can edit them as needed—will be uploaded as attachments in “Consents” Informed consent/parent permission/assent/fact sheets will be constructed within the program. Specific forms will be required based on how you responded to various questions. You can edit them as needed—will be uploaded as attachments in “Consents” Justification in IRB application for waivers of signature if necessary Justification in IRB application for waivers of signature if necessary Justification in IRB application for consent waiver if secondary analysis Justification in IRB application for consent waiver if secondary analysis All other documents that will be used with subjects (e.g., recruitment letter, flyers, questionnaires, focus group guide, and other instruments, even if draft, will also be uploaded as attachments in “Attachments” All other documents that will be used with subjects (e.g., recruitment letter, flyers, questionnaires, focus group guide, and other instruments, even if draft, will also be uploaded as attachments in “Attachments” Copy of research proposal (ONLY IF FUNDED RESEARCH) Copy of research proposal (ONLY IF FUNDED RESEARCH) I strongly recommend NOT submitting student proposals if there is no grant supporting them I strongly recommend NOT submitting student proposals if there is no grant supporting them BDG for SoE

22 My personal advice Lay out a detailed study plan on paper FIRST, for a clear picture of what you want to do, when, with whom, and how you will recruit, obtain consent, and collect data, or what datasets you will analyze—the form can be confusing. Lay out a detailed study plan on paper FIRST, for a clear picture of what you want to do, when, with whom, and how you will recruit, obtain consent, and collect data, or what datasets you will analyze—the form can be confusing. THEN do a mock-up of the application—you can put in as much or as little “good” info in textboxes as you like, but you must answer questions with “radio buttons” so you see all the questions that will need answers--later questions depend on answers to earlier ones. READ CAREFULLY!! THEN do a mock-up of the application—you can put in as much or as little “good” info in textboxes as you like, but you must answer questions with “radio buttons” so you see all the questions that will need answers--later questions depend on answers to earlier ones. READ CAREFULLY!! Add to your paper plan where needed, and then start filling in the application with more complete, “good” text. Add to your paper plan where needed, and then start filling in the application with more complete, “good” text. Consult with your advisor—that’s who the IRB folks consider “responsible” for the study—get advice, advisor can edit your drafts online, you can send pdfs, etc. Chances are it will take several drafts—this takes time and thought. Consult with your advisor—that’s who the IRB folks consider “responsible” for the study—get advice, advisor can edit your drafts online, you can send pdfs, etc. Chances are it will take several drafts—this takes time and thought. You may also ask the IRB coordinators for help (6-3113). You may also ask the IRB coordinators for help (6-3113). BDG for SoE

23 The IRB application for APPROVAL must be presented with enough information for the reviewers to evaluate risks and benefits, adequacy of consent procedures, and protection of confidentiality The IRB application for APPROVAL must be presented with enough information for the reviewers to evaluate risks and benefits, adequacy of consent procedures, and protection of confidentiality The IRB IS REQUIRED to determine whether there is a favorable risk-to-benefit ratio for studies with direct interaction, and for secondary analyses with identifiable data, and only approve a study if that ratio is “favorable,” which means MORE BENEFIT (generalizable knowledge) than risk to participants The IRB IS REQUIRED to determine whether there is a favorable risk-to-benefit ratio for studies with direct interaction, and for secondary analyses with identifiable data, and only approve a study if that ratio is “favorable,” which means MORE BENEFIT (generalizable knowledge) than risk to participants The online application will also provide guidance at the end about maintaining the security (confidentiality) of your data, based on your responses to the questions. You will be told what protections are recommended for your study, in terms of whether it needs Level I, Level II, or Level III security measures. You may need to consult with departmental IT people for assistance. The online application will also provide guidance at the end about maintaining the security (confidentiality) of your data, based on your responses to the questions. You will be told what protections are recommended for your study, in terms of whether it needs Level I, Level II, or Level III security measures. You may need to consult with departmental IT people for assistance. End of OVERVIEW End of OVERVIEW BDG for SoE

24 Using the 3 principles from the Belmont Report when collecting data from individuals as part of “human subjects research” OR as part of class projects BDG for SoE

25 Using the 3 principles from the Belmont Report when collecting data from individuals as part of “human subjects research” Belmont principle #1, Respect for persons, is seen in the recognition of the personal dignity and autonomy of individuals, with special protections for those with diminished autonomy Belmont principle #1, Respect for persons, is seen in the recognition of the personal dignity and autonomy of individuals, with special protections for those with diminished autonomy Applications: Applications: Protecting privacy and confidentiality (almost always, unless agreed otherwise) Protecting privacy and confidentiality (almost always, unless agreed otherwise) Informed consent Informed consent Voluntariness—no coercion or subtle pressure Voluntariness—no coercion or subtle pressure BDG for SoE

26 Respecting Privacy and Protecting Confidentiality Recruitment of subjects—maintain privacy (usually) Recruitment of subjects—maintain privacy (usually) In general, names should not be given to researchers, as in “snowball recruitment” without first asking permission of the individual whose name is given—other ways to handle this In general, names should not be given to researchers, as in “snowball recruitment” without first asking permission of the individual whose name is given—other ways to handle this BUT names can be obtained from organizations when membership is not sensitive—but be sure to tell participants how you got their name BUT names can be obtained from organizations when membership is not sensitive—but be sure to tell participants how you got their name Data collection procedures should respect privacy Data collection procedures should respect privacy Confidentiality: protection of data, especially if sensitive Confidentiality: protection of data, especially if sensitive What is sensitive can depend on the context What is sensitive can depend on the context Usually or always sensitive: illegal behavior, immigration status, sexual behavior, health status (e.g., specific disease status) IF IDENTIFIABLE Usually or always sensitive: illegal behavior, immigration status, sexual behavior, health status (e.g., specific disease status) IF IDENTIFIABLE Potentially sensitive depending on cultural context: income, membership in specific organizations, workplace competency (often not considered) Potentially sensitive depending on cultural context: income, membership in specific organizations, workplace competency (often not considered) Minimization of risk of deductive disclosure by “insiders” who have knowledge of the participant pool Minimization of risk of deductive disclosure by “insiders” who have knowledge of the participant pool Separation of data from identifying information Separation of data from identifying information BDG for SoE

27 Informed Consent Consent is a PROCESS... Consent is a PROCESS... Researcher tells all the important information, emphasizing voluntariness in multiple ways Researcher tells all the important information, emphasizing voluntariness in multiple ways Participant has chance to ask questions Participant has chance to ask questions Researcher answers questions Researcher answers questions Participant (usually) signs a consent form agreeing to participate, but information can be shared orally, and consent can be oral Participant (usually) signs a consent form agreeing to participate, but information can be shared orally, and consent can be oral BDG for SoE

28 Informed Consent for RESEARCH The “spiel” or the form, includes: Purpose of the research Purpose of the research What the person will be asked to do, and how long it takes What the person will be asked to do, and how long it takes Description of risks and benefits, if any Description of risks and benefits, if any Costs; incentive payments for participation Costs; incentive payments for participation Confidentiality statement and procedures description Confidentiality statement and procedures description Subject rights: Right to not participate, participate in part, discontinue participation Subject rights: Right to not participate, participate in part, discontinue participation IRB contact information for concerns about rights IRB contact information for concerns about rights Researcher contact information for questions about study Researcher contact information for questions about study The online template will “pre-populate” some of the information at the top of the 1 st page, but you will need to write/edit the information on the rest of the form. You may instead craft and upload a different format or process that is more appropriate for your specific study and your participants. If you do this, do explain why you are doing so BDG for SoE

29 Informed Consent for CLASS PROJECTS or PRACTICA that do not need IRB approval More flexible but generally similar to “research” information on the “standard IRB consent” or “Fact sheet” but definitely have many options for formatting, sequencing, etc. More flexible but generally similar to “research” information on the “standard IRB consent” or “Fact sheet” but definitely have many options for formatting, sequencing, etc. However, the same ethical principles apply, and similar information needs to be provided However, the same ethical principles apply, and similar information needs to be provided Purpose Purpose What the person will be asked to do, and how long it will take What the person will be asked to do, and how long it will take Whether information will be confidential Whether information will be confidential Risks and benefits, if any Risks and benefits, if any Can choose not to participate, can skip over parts, can quit at any time (entirely voluntary) Can choose not to participate, can skip over parts, can quit at any time (entirely voluntary) But DO NOT use the standard IRB template form, if using written consent—use one developed specifically for the project, practicum, or evaluation, and in that form, be sure to follow the guidance below But DO NOT use the standard IRB template form, if using written consent—use one developed specifically for the project, practicum, or evaluation, and in that form, be sure to follow the guidance below DO NOT use the word “research” since by definition, a class project, practicum, or “in-house” evaluation, is NOT research DO NOT use the word “research” since by definition, a class project, practicum, or “in-house” evaluation, is NOT research DO NOT refer PROJECT participants to the IRB for concerns DO NOT refer PROJECT participants to the IRB for concerns They contact the student and faculty advisor with any questions or concerns (IRB NOT involved) They contact the student and faculty advisor with any questions or concerns (IRB NOT involved) BDG for SoE

30 Other Consent Matters Parent permission required for participation by minors, although waivers may be possible Parent permission required for participation by minors, although waivers may be possible Children “assent” instead of “consent”-- may be signed, depending on age, or only oral--IRB may prefer written assent if the minors are older and if the activity is “RESEARCH” but what is appropriate depends on the nature of the study Children “assent” instead of “consent”-- may be signed, depending on age, or only oral--IRB may prefer written assent if the minors are older and if the activity is “RESEARCH” but what is appropriate depends on the nature of the study Fact sheet: Same information as a consent form, but without a signature—often accompanies oral explanation and oral consent, or is sent along with surveys and questionnaires Fact sheet: Same information as a consent form, but without a signature—often accompanies oral explanation and oral consent, or is sent along with surveys and questionnaires Fact sheet for class projects and practica also can take advantage of increased flexibility—key is content appropriate for the project/practicum Fact sheet for class projects and practica also can take advantage of increased flexibility—key is content appropriate for the project/practicum For “RESEARCH” the IRB may grant a waiver of signed (“written”) consent, or of omission of consent elements, or of consent or parent permisison entirely, as specified in the Code of Federal Regulations (CFR) For “RESEARCH” the IRB may grant a waiver of signed (“written”) consent, or of omission of consent elements, or of consent or parent permisison entirely, as specified in the Code of Federal Regulations (CFR) For class projects/practica, student and faculty member decide together what is appropriate for particular activities For class projects/practica, student and faculty member decide together what is appropriate for particular activities BDG for SoE

31 Belmont principle #2, beneficience, is seen in protecting participants from harm (minimizing risks), and determining that there are sufficient benefits (to individual participants and to society, in the form of knowledge) to balance the risks to participants Belmont principle #2, beneficience, is seen in protecting participants from harm (minimizing risks), and determining that there are sufficient benefits (to individual participants and to society, in the form of knowledge) to balance the risks to participants IRB has to decide there is a favorable risk:benefit ratio (more benefit than risk) to approve IRB has to decide there is a favorable risk:benefit ratio (more benefit than risk) to approve Benefit can be to participants AND to society, in the form of scientific knowledge, but risks are only to participants Benefit can be to participants AND to society, in the form of scientific knowledge, but risks are only to participants If there is no risk, then it’s ok if the participants don’t benefit, and the scientific merit may be minimal too. If there is no risk, then it’s ok if the participants don’t benefit, and the scientific merit may be minimal too. BDG for SoE

32 Types of Risk the IRB (and YOU) Need to Consider MOST risk in studies that do NOT involve treatment stem from problems that could ensue if there were accidental disclosures, or breaches of confidentiality MOST risk in studies that do NOT involve treatment stem from problems that could ensue if there were accidental disclosures, or breaches of confidentiality about illegal behaviors such as underage alcohol use, underage sexual behavior, illegal drug use, about illegal behaviors such as underage alcohol use, underage sexual behavior, illegal drug use, about “sensitive” information such as diagnoses, workplace competence, and so forth about “sensitive” information such as diagnoses, workplace competence, and so forth Risk can be: Risk can be: Physical (e.g. pain, drug side effects, or injury) in some studies Physical (e.g. pain, drug side effects, or injury) in some studies Psychological (e.g. emotional distress) Psychological (e.g. emotional distress) Social (e.g. stigmatization) Social (e.g. stigmatization) Economic (e.g. loss of job—related breach of confidentiality that relates to stigma, or workplace competency issues) Economic (e.g. loss of job—related breach of confidentiality that relates to stigma, or workplace competency issues) Legal (requirements to report some illegal activities, whether they are the focus of the study, or reports emerge without prompting) Legal (requirements to report some illegal activities, whether they are the focus of the study, or reports emerge without prompting) BDG for SoE

33 Belmont principle #3, justice, is seen in the selection of subjects and protections for vulnerable populations Belmont principle #3, justice, is seen in the selection of subjects and protections for vulnerable populations Selection of subjects needs to be FAIR: Selection of subjects needs to be FAIR: If there is a possibility of benefit from the research (not true for many studies) If there is a possibility of benefit from the research (not true for many studies) If there is the chance of risk, but no real chance of benefit to participants—need to avoid burdening participants unfairly If there is the chance of risk, but no real chance of benefit to participants—need to avoid burdening participants unfairly If no appreciable benefit and no real burden, then less of an issue If no appreciable benefit and no real burden, then less of an issue Researchers must provide additional protections for vulnerable populations Researchers must provide additional protections for vulnerable populations Children (Subpart D) Children (Subpart D) Pregnant women (if recruited intentionally for a study that impacts them or their fetuses) (Subpart B) Pregnant women (if recruited intentionally for a study that impacts them or their fetuses) (Subpart B) Prisoners (Subpart C) Prisoners (Subpart C) Individuals who are “decisionally impaired” or who have diminished capacity (no separate subpart, just provisions) Individuals who are “decisionally impaired” or who have diminished capacity (no separate subpart, just provisions) BDG for SoE

34 Belmont principle #3, justice, vulnerable populations continued Belmont principle #3, justice, vulnerable populations continued More than one Subpart of 45 CFR 46 may apply More than one Subpart of 45 CFR 46 may apply Subparts D+C, for children and prisoners, would apply for youth who are being detained in a juvenile facility Subparts D+C, for children and prisoners, would apply for youth who are being detained in a juvenile facility Consent process needs to deal with issues of feeling coerced, of understanding their rights in a context of limited rights, how researchers can contact parents, whether the facility would allow a waiver of parental permission, etc. Consent process needs to deal with issues of feeling coerced, of understanding their rights in a context of limited rights, how researchers can contact parents, whether the facility would allow a waiver of parental permission, etc. Be sure to obtain guidance from the facility about the multiple steps involved in conducting research in these kinds of facilities—this may include going through additional review with officials responsible for research in prison facilities Be sure to obtain guidance from the facility about the multiple steps involved in conducting research in these kinds of facilities—this may include going through additional review with officials responsible for research in prison facilities BDG for SoE

35 Belmont principle #3, justice, vulnerable populations, cont. Belmont principle #3, justice, vulnerable populations, cont. Subpart D+ provisions (not yet a subpart) for individuals who are both minors AND could be considered to be “decisionally impaired” or to have “diminished capacity” to decide about research participation Subpart D+ provisions (not yet a subpart) for individuals who are both minors AND could be considered to be “decisionally impaired” or to have “diminished capacity” to decide about research participation This could be true for studies that involve children and adolescents with intellectual disabilities or delays, conditions such as autism or considerable learning disabilities, and so forth This could be true for studies that involve children and adolescents with intellectual disabilities or delays, conditions such as autism or considerable learning disabilities, and so forth Consider carefully the appropriate ways to obtain parental permission and meaningful child assent for these children Consider carefully the appropriate ways to obtain parental permission and meaningful child assent for these children NOTE: you do NOT need to check “decisionally impaired” in the online application’s list of vulnerable populations—the parent permission for a minor will be handling the legal aspect of the requirement for informed consent, but you should describe what you will be doing that might be different than it would be for a typical child of the same age, such as just obtaining oral assent, in order to be appropriate for your participants NOTE: you do NOT need to check “decisionally impaired” in the online application’s list of vulnerable populations—the parent permission for a minor will be handling the legal aspect of the requirement for informed consent, but you should describe what you will be doing that might be different than it would be for a typical child of the same age, such as just obtaining oral assent, in order to be appropriate for your participants END of Part 2, Belmont Principles in Practice BDG for SoE

36 Part 3: Issues Specific to Research with Children in Elementary and Secondary Schools 45 CFR 46, Subpart D has included special rules for the protection of children in general that also apply to students in schools 45 CFR 46, Subpart D has included special rules for the protection of children in general that also apply to students in schools Additional federal laws protect information in students’ educational records: Additional federal laws protect information in students’ educational records: The Family Education Rights and Privacy Act (FERPA) or the Buckley Amendment, gives parents certain rights over the content of their children’s educational records The Family Education Rights and Privacy Act (FERPA) or the Buckley Amendment, gives parents certain rights over the content of their children’s educational records The Protection of Pupil Rights Amendment (PPRA), amended by a rider on the “No Child Left Behind Act” in 2001, was intended to provide (require) parental permission (consent) over the CONTENT of surveys, instructional materials, analyses, and evaluations of students, with the level of control depending upon the source of funding for the research The Protection of Pupil Rights Amendment (PPRA), amended by a rider on the “No Child Left Behind Act” in 2001, was intended to provide (require) parental permission (consent) over the CONTENT of surveys, instructional materials, analyses, and evaluations of students, with the level of control depending upon the source of funding for the research BDG for SoE

37 Issues Specific to Research with Children in Elementary and Secondary Schools, continued The Family Education Rights and Privacy Act (FERPA) The Family Education Rights and Privacy Act (FERPA) Gives parents certain rights over the sharing of the content of their children’s educational records Gives parents certain rights over the sharing of the content of their children’s educational records Those rights transfer to the students when they turn 18 Those rights transfer to the students when they turn 18 Generally, schools MUST have written permission from the parent (or student at 18+) before releasing any IDENTIFIABLE information from a student’s record, including information about grades, test scores, attendance, disciplinary actions, gender, ethnicity, citizenship, and religious affiliation Generally, schools MUST have written permission from the parent (or student at 18+) before releasing any IDENTIFIABLE information from a student’s record, including information about grades, test scores, attendance, disciplinary actions, gender, ethnicity, citizenship, and religious affiliation FERPA does allow schools to disclose IDENTIFIABLE records WITHOUT PARENTAL PERMISSION OR STUDENT CONSENT to certain parties, including organizations conducting research, when the school, school district, or state department of instruction initiates the research FERPA does allow schools to disclose IDENTIFIABLE records WITHOUT PARENTAL PERMISSION OR STUDENT CONSENT to certain parties, including organizations conducting research, when the school, school district, or state department of instruction initiates the research BDG for SoE

38 Issues Specific to Research with Children in Elementary and Secondary Schools, continued The Family Education Rights and Privacy Act (FERPA), continued The Family Education Rights and Privacy Act (FERPA), continued Schools can also disclose without consent “directory” information but must tell parents and eligible students (18+) that the directory information is not protected, and allow them to request that the school not disclose such information about them Schools can also disclose without consent “directory” information but must tell parents and eligible students (18+) that the directory information is not protected, and allow them to request that the school not disclose such information about them Directory information: name, address, telephone number, date of birth (so age can be determined) and place of birth (citizenship), dates of attendance, honors and awards Directory information: name, address, telephone number, date of birth (so age can be determined) and place of birth (citizenship), dates of attendance, honors and awards Researchers themselves can request school records that are NOT identifiable for secondary analysis – FERPA not an issue when records are not identifiable, but the IRB may be concerned about “deductive disclosure of identity” if combinations of rare characteristics allow for the researcher to deduce the identity of a student (e.g., the only 11-year-old Latina in 8 th grade algebra in a specific school) Researchers themselves can request school records that are NOT identifiable for secondary analysis – FERPA not an issue when records are not identifiable, but the IRB may be concerned about “deductive disclosure of identity” if combinations of rare characteristics allow for the researcher to deduce the identity of a student (e.g., the only 11-year-old Latina in 8 th grade algebra in a specific school) BDG for SoE

39 Issues Specific to Research with Children in Elementary and Secondary Schools, continued The Protection of Pupil Rights Amendment (PPRA), provides (requires) parental permission for their child’s participation in or exposure to third-party (not the school’s own) survey research or curricula that include any of 8 sensitive topics: The Protection of Pupil Rights Amendment (PPRA), provides (requires) parental permission for their child’s participation in or exposure to third-party (not the school’s own) survey research or curricula that include any of 8 sensitive topics: Political affiliations or beliefs of the student or the student’s parent Political affiliations or beliefs of the student or the student’s parent Mental and psychological problems of the student or the student’s family members Mental and psychological problems of the student or the student’s family members Sexual behavior and attitudes Sexual behavior and attitudes Illegal, anti-social, self-incriminating, or demeaning behavior Illegal, anti-social, self-incriminating, or demeaning behavior Critical appraisals of family members Critical appraisals of family members Legally recognized privileged or analogous relationships, such as with lawyers, physicians, or ministers Legally recognized privileged or analogous relationships, such as with lawyers, physicians, or ministers Religious practices, affiliations, or beliefs of the student or parents Religious practices, affiliations, or beliefs of the student or parents Income other than that required by law to determine eligibility Income other than that required by law to determine eligibility BDG for SoE

40 Issues Specific to Research with Children in Elementary and Secondary Schools, continued Protection of Pupil Rights Amendment (PPRA), cont. Protection of Pupil Rights Amendment (PPRA), cont. If the research asks students to provide information about any of the 8 topics, AND the research is funded in whole or in part by ANY program administered by the US Dept of Education, the requirement for parental permission CANNOT be waived by the IRB If the research asks students to provide information about any of the 8 topics, AND the research is funded in whole or in part by ANY program administered by the US Dept of Education, the requirement for parental permission CANNOT be waived by the IRB PPRA does NOT require written parental permission for the use of surveys and related instructional materials when the research is NOT funded by the Department of Education, so the IRB can waive the requirement if there is sufficient reason to do so (criteria built into application) PPRA does NOT require written parental permission for the use of surveys and related instructional materials when the research is NOT funded by the Department of Education, so the IRB can waive the requirement if there is sufficient reason to do so (criteria built into application) PPRA DOES require that every public school system that ACCEPTS ANY MONEY from the Department of Education (which means ALL public elementary and secondary schools) have a policy that informs parents about their rights to inspect third-party surveys and instructional materials and ask that their children not participate PPRA DOES require that every public school system that ACCEPTS ANY MONEY from the Department of Education (which means ALL public elementary and secondary schools) have a policy that informs parents about their rights to inspect third-party surveys and instructional materials and ask that their children not participate BDG for SoE

41 Other issues related to research with children in schools, continued PARENT PERMISSION: Even when parents have provided permission for their children to participate in research, children must still be allowed to provide assent (or decline) in a manner that is appropriate for their age and maturity PARENT PERMISSION: Even when parents have provided permission for their children to participate in research, children must still be allowed to provide assent (or decline) in a manner that is appropriate for their age and maturity Children should not be made to feel pressured to participate—if they feel even subtle coercion, then their participation is not truly voluntary Children should not be made to feel pressured to participate—if they feel even subtle coercion, then their participation is not truly voluntary They should be told explicitly that even though their parents have given permission, they can decide whether they want to be in the study, that they can stop at any time, and that they can skip over questions or parts of the study they don’t want to answer or do They should be told explicitly that even though their parents have given permission, they can decide whether they want to be in the study, that they can stop at any time, and that they can skip over questions or parts of the study they don’t want to answer or do Children, especially younger children, may need to be reassured explicitly that neither their parents, nor their teacher, nor the researcher will be mad at them, or disappointed, if they choose not to participate in the study or to stop early Children, especially younger children, may need to be reassured explicitly that neither their parents, nor their teacher, nor the researcher will be mad at them, or disappointed, if they choose not to participate in the study or to stop early Children, especially older children, may be concerned about what their classmates are doing, and could feel some peer pressure to participate, or not to participate—they need privacy to make their decisions Children, especially older children, may be concerned about what their classmates are doing, and could feel some peer pressure to participate, or not to participate—they need privacy to make their decisions BDG for SoE

42 Other issues related to research with children in schools, continued Protection from research-related harms Protection from research-related harms Participation should not subject children to stigma or ridicule by their peers—so studies that focus on problematic behaviors need to be carefully designed to prevent such harms Participation should not subject children to stigma or ridicule by their peers—so studies that focus on problematic behaviors need to be carefully designed to prevent such harms Parents and older children need to be informed that promised protections of confidentiality may be restricted by requirements to report child abuse and neglect Parents and older children need to be informed that promised protections of confidentiality may be restricted by requirements to report child abuse and neglect Not necessary to include such information for every study—need to consider the topic of the research, and the sample, to determine if it makes sense Not necessary to include such information for every study—need to consider the topic of the research, and the sample, to determine if it makes sense Should indicate explicitly that there are, or are not questions that relate to this if it is mentioned at all Should indicate explicitly that there are, or are not questions that relate to this if it is mentioned at all BDG for SoE

43 Other issues related to research with children in schools, cont. Feasibility/scouting or “soft scoping” Feasibility/scouting or “soft scoping” Researchers will frequently need to make preliminary contacts with school and/or district personnel to determine the feasibility of their studies (e.g., enough students of various ages, enrollment of certain kinds of students or existence of certain programs, times of the year when research is allowed) Researchers will frequently need to make preliminary contacts with school and/or district personnel to determine the feasibility of their studies (e.g., enough students of various ages, enrollment of certain kinds of students or existence of certain programs, times of the year when research is allowed) Researchers will also need to inquire about local procedures and preferences—how can children be recruited, can information be sent home via the PTA newsletter, etc. Researchers will also need to inquire about local procedures and preferences—how can children be recruited, can information be sent home via the PTA newsletter, etc. “Soft Scope” the situation BEFORE submitting the IRB application so you can provide reasonable information about recruitment, parental permission, and how and when and where the study will be conducted “Soft Scope” the situation BEFORE submitting the IRB application so you can provide reasonable information about recruitment, parental permission, and how and when and where the study will be conducted This is NOT recruitment, and that needs to be clear to all concerned—school personnel CANNOT agree formally to allow you to conduct a study before you get IRB approval This is NOT recruitment, and that needs to be clear to all concerned—school personnel CANNOT agree formally to allow you to conduct a study before you get IRB approval BDG for SoE

44 Other issues related to research with children in schools, continued Dual roles: teacher & researcher (2-hat problem) Dual roles: teacher & researcher (2-hat problem) Researchers who are already employed by schools and have returned to graduate school part-time, or students doing internships or practice teaching, need to be VERY careful about the conflicts in their two roles Researchers who are already employed by schools and have returned to graduate school part-time, or students doing internships or practice teaching, need to be VERY careful about the conflicts in their two roles Teachers do NOT have legitimate access AS RESEARCHERS to the information they have access to as teachers without additional processes Teachers do NOT have legitimate access AS RESEARCHERS to the information they have access to as teachers without additional processes Teachers need to be VERY wary about conducting research on the children they teach—parents do NOT expect random assignment to groups, for example—they expect teachers to do what is in the best interests of the child, not of a study Teachers need to be VERY wary about conducting research on the children they teach—parents do NOT expect random assignment to groups, for example—they expect teachers to do what is in the best interests of the child, not of a study BDG for SoE

45 Other issues related to research with children in schools, continued Dual roles: teacher & researcher (2-hat problem) continued Dual roles: teacher & researcher (2-hat problem) continued Parents cannot readily feel that giving permission for their child to participate, or giving consent for their own participation, is voluntary when the person asking is the child’s own teacher Parents cannot readily feel that giving permission for their child to participate, or giving consent for their own participation, is voluntary when the person asking is the child’s own teacher Older students can feel “used” when they discover that their teacher has used their assignments for his/her own research purposes—they may wonder if the assignment was really to help them learn, or just to help the teacher/grad student complete a course or a thesis Older students can feel “used” when they discover that their teacher has used their assignments for his/her own research purposes—they may wonder if the assignment was really to help them learn, or just to help the teacher/grad student complete a course or a thesis Doing pedagogical research in one’s own class is not always forbidden, but it is VERY complicated, and requires consultation/negotiation with the IRB Doing pedagogical research in one’s own class is not always forbidden, but it is VERY complicated, and requires consultation/negotiation with the IRB BDG for SoE

46 For ANY and all questions, students should talk with their advisor(s) FIRST, and faculty may want to talk to other faculty who have done similar kinds of work. For ANY and all questions, students should talk with their advisor(s) FIRST, and faculty may want to talk to other faculty who have done similar kinds of work. If there is still any doubt about the appropriate course of action, contact the IRB—there are IRB coordinators & IRB chairs who can help If there is still any doubt about the appropriate course of action, contact the IRB—there are IRB coordinators & IRB chairs who can help IRB phone general number, so you should ask for the behavioral coordinators and/or the behavioral chairs (though they are only occasionally in the office IRB phone general number, so you should ask for the behavioral coordinators and/or the behavioral chairs (though they are only occasionally in the office IRB website IRB website BDG for SoE


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