RESEARCH ETHICS Orientation for IRB Members Session 1: The Regulations and the Role of The IRB

1. RESEARCH ETHICS Orientation for IRB Members Session 1: The Regulations and the Role of The IRB Presented by the Office of Sponsored Programs & Research Administration

2. Historical Timeline • 1947: Nazi War Crimes Tribunal issued Nuremburg Code • 1940s: PHS Tuskegee syphilis study • Late 1950s – Early 1960s: The thalidomide tragedy • 1963: Milgram’s obedience study published • 1964: Declaration of Helsinki/World Medical Assembly • 1974: National Research Act (IRB review for federally funded research) • 1974: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research established • 1979: Belmont Report issued; ethical principles defined • 1980: FDA regulations for testing of new drugs and devices codified

3. Historical Timeline • 1980: FDA regulations for testing of new drugs and devices codified • 1981: DHHS human subject protection regulations codified (45 CFR 46) • 1991: Federal Policy for the Protection of Human Subjects (“Common Rule”) • 1993: Albuquerque Tribune publicizes 1940s secret radiation experiments • 1994: National Bioethics Advisory Commission (NBAC) created • 1995: U.S. universities surveyed re: old radiation studies • 2000: U.S. Public Health Service mandates researcher education • 2001: Office of Human Research Protections (OHRP) established within DHHS • 2002: NBAC sunsets • 2003: Secretary’s Advisory Committee on Human Research Protection established

4. Belmont Principles • Autonomy (Respect for Persons) • Give respect, time, and opportunity to participants to make their own decisions • Avoid pressuring or coercing individuals to participate • Provide special protections for potentially vulnerable populations (children, elderly, cognitively or emotionally impaired, prisoners, etc.) • Be aware of the perception of inequality of roles and/or potential for coercion in relationships • Teacher-Student • Employer-Employee • Counselor-Client • Service Provider-Service Recipient

5. Belmont Principles • Derived Rules from the Principle of Autonomy • Securing Informed Consent • Ongoing educational process to ensure participants’ understanding of the research and their willingness to participate • Respecting Privacy of the Individual • Individual’s right to control access to him/herself and to his/her personal information • Protecting Confidentiality of Information • Agreement made with research participants about how information about the participant will be protected

6. Belmont Principles • What is private information? • Behavior or information is considered private if it occurs in a context in which the individual can reasonably assume that no observation or recording is taking place or can reasonably expect will not be made public (such as medical or educational record) • Participants’ expectations form basis of making distinctions between public and private behavior • May have some expectation of privacy, even in a public setting

7. Belmont Principles • Privacy Concerns in Identification and Recruitment • Sampling methods • For example, “snowball sampling” • Covert observation or video or audio taping • Approaching in a public setting • Safety concerns (gang member on the street; domestic violence victim) • Recruiting via an employer’s email system • Concerns with sensitive information

8. Belmont Principles • Thinking Through Privacy Issues • Is it a situation in which the participant could reasonably expect privacy? • Would reasonable people be offended by such intrusion? • Would information gathered place the participant at risk of harm if disclosed? • Do benefits of the study justify the possible invasion of privacy? • What will the participants be told after the study? • Can the study be redesigned to avoid the intrusion? • Are there third parties whose privacy would be invaded (for example, asking children about parental drug use or other illegal behavior)?

9. Belmont Principles • Ensuring Confidentiality • If possible, use a study design that assures anonymity (no true identifiers) • Must ensure confidentiality and communicate measures to participants if • Data are individually identifiable • Research topic is sensitive • Participants will be audio- or video-taped • Data will be used for purposes other than the original study

10. Belmont Principles • Confidentiality Considerations • Is there a real need for identifiers? • Can code lists or participant-created identifiers be used? • Can identifiers or code lists be destroyed after data collection? • Who will have access to the data, now and in the future? • How will data be reported (aggregate, pseudonyms, real names?) • What will become of video or audio tapes (destruction, used for teaching, shown at meetings, saved for future research)? • Protection of data from inadvertent disclosure (authorized staff, computer passwords, locked file cabinets)? • Are the data destruction methods appropriate? • Federal regulations require retention of data for at least three years

11. Belmont Principles • Beneficence • Secure the well-being of research participants • Minimize harm to participants • Maximize benefits to participants and to society • Carefully balance risks and benefits to the participants

12. Belmont Principles • Derived Rules from the Principle of Beneficence • Use the best possible research design • Ensure that the researcher is qualified to perform the procedures and handle the risks • Refrain from the conduct of research that is without a favorable risk-benefit balance if risk is greater than minimal

13. Belmont Principles • Justice • Distribute benefits and burdens of the research fairly and without bias • Do not select or restrict participants based on gender, class, ethnicity, socioeconomic status, or language ability (unless justified by study objectives) • Avoid selection of participants based on • Convenience of researcher • Participant availability • Compromised position of participants • Ability to manipulate participants

14. The DHHS Regulations (45 CFR 46) • Underpinned by the Belmont Report principles • Establishes oversight of federally funded human research • Establishes Institutional Review Boards (IRBs) for the protection of human research participants • Establishes institutional assurance mechanism

15. FederalWide Assurance (FWA) Program • Federal policy requires that institutions engaged in federally-supported research involving human participants file an Assurance • The Assurance formalizes the institution’s commitment to protect human subjects • The Assurance includes both “awardee” and collaborating “performance site” institutions

16. VSU’s FWA • VSU has assured DHHS that it: • Accepts the ethical principles of the Belmont Report • Complies with the Federal Policy for Protection of Human Subjects (the Common Rule) • Has adopted all subparts of the regulations (45 CFR 46) • Verifies exemptions from the Common Rule • Maintains an IRB in accordance with the regulations • Requires assurance training of IRB members and staff • Requires education of all researchers • Applies protections to all participants, regardless of funding source

17. VSU’s FWA • VSU has assured DHHS that it maintains written procedures for: • Conducting IRB initial and continuing reviews • Approving research involving human participants • Ensuring documentation of informed consent • Ensuring that proposed protocol changes are reported, reviewed, and approved prior to implementation • Reporting findings to the IRB and institution • Initial and continuing reviews • Adverse events and unanticipated problems • Serious or continuing non-compliance with regulations or IRB policies • Suspension or termination of protocols

18. The Institutional Review Board (IRB) • Mandated to safeguard the rights and welfare of research participants by • Reviewing research protocols • Requiring protocol modifications as necessary • Approving or disapproving protocols • Ensuring or waiving informed consent and/or documentation of informed consent • Conduct continuing review of research

19. Constitution of IRB • At least five members with varying backgrounds • Different professions • At least one scientist and one non-scientist • At least one non-affiliated (community) member • Prisoner or prisoner representative if institution engages in prisoner research • Diversity in gender, ethnicity, and cultural background • Sensitivity to community attitudes • Knowledgeable in standards of professional conduct and practice • Outside consultants may be used • Alternate members may serve as proxies for designated voting members at convened meetings (but not as expediters) • Members with conflicting interests may not participate in protocol reviews.

20. IRB Jurisdiction • The IRB has jurisdiction over research conducted by VSU • Faculty members • Staff • Students • in any location • On the VSU campus • At another institution or organization • In a community setting • In a foreign country

21. IRB Authority The IRB’s decision to deny approval of a protocol cannot be overridden by the President, any member of the administration, or the Board of Regents. The IRB’s decision is final.

22. CITIProgram.org Training for Researchers • Basic Course • Introduction • History and Ethical Principles – SBR • Defining Research with Human Subjects – SBR • The Regulations and the Social and Behavioral Sciences – SBR • Basic Institutional Review Board (IRB) Regulations and Review Process • Assessing Risk in Social and Behavioral Sciences – SBR • Informed Consent – SBR • Privacy and Confidentiality – SBR • VSU Module (SBR = Social and Behavioral Research)

23. CITIProgram.org Training for Researchers • Additional Required (?) Modules Based on Research Design • Research with Children - SBR • Research in Public Elementary and Secondary Schools - SBR • Vulnerable Subjects – Research Involving Pregnant Women and Fetuses in utero • Research with Prisoners - SBR • Research with Protected Populations – Vulnerable Subjects: An Overview • International Research • Group Harms: Research with Culturally or Medically Vulnerable Groups • Records-Based Research • Genetic Research in Human Populations • HIPAA and Human Subjects Research (personal medical information) • Internet Research - SBR • Workers as Research Subjects – A Vulnerable Population

24. Additional Training for IRB Members • CITIProgram.org IRB Reference Resource (all IRB modules) • OHRP Human Subjects Assurance Training • Module 1 - HHS Regulations & Institutional Responsibilities • Module 2 - Investigator Responsibilities & Informed Consent • Module 3 - Human Research Protections Program Module 1 is strongly recommended for the Institutional Official. All three modules are required for the IRB Chair and the IRB Administrator. All IRB members are invited to complete the modules. http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp

25. Other Resources for IRB Members • OHRP (http://www.hhs.gov/ohrp/) • Institutional Review Board (IRB) Guidebook On-Line • http://www.hhs.gov/ohrp/irb/irb_guidebook.htm • Policy and Guidance • http://www.hhs.gov/ohrp/policy/index.html • Frequently Asked Questions (FAQs) • http://www.hhs.gov/ohrp/faq.html • VSU IRB Website • Policy and procedures, guidance, forms, membership, meeting dates • http://www.valdosta.edu/ospra/HumanResearchParticipants.shtml

26. Federal Definitions • Researchis a systematic investigation intended to develop or contribute to generalizable knowledge • The regulations do not define “systematic” or “generalizable knowledge” • Systematic: adj. “Methodical in procedure or plan (a systematic approach) (a systematic scholar); marked by thoroughness and regularity (systematic efforts)” – Merriam-Webster Dictionary • Generalizable Knowledge infers a quantitative methodology which allows generalization of research findings to a larger population. • For VSU IRB purposes, a systematic investigation intended to advance disciplinary knowledge is also included in the definition of research • Includes qualitative research See handout on qualitative and quantitative research.

27. Federal Definitions • Human Participantis a living individual about whom the investigator obtains • Data through interventionor interaction with the individual and/or • Identifiable private information

28. Federal Definitions • Intervention includes • Physical procedures such as specimen collection and physical measurements • Manipulation of the participant • Manipulation of the participant’s environment • Interaction includes • Direct communication with the participant (such as interviewing or conducting a focus group) • Interpersonal contact with the participant (such as surveying)

29. Federal Definitions • Private Information is • Information about behavior that the participant can reasonably expect is not being observed or recorded (for example, restroom habits) • Information provided by the participant that he/she reasonably expects will not be made public (such as a medical, personnel, or academic record) • Identifiable means • The participant’s identity can be readily ascertained by investigator or • The participant’s identity can be associated with the information directly or through the use of identifiers

30. Federal Definitions • Minimal Risk- Risk is considered minimal when the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests The concept of risk goes beyond physical risk and includes psychological, emotional, or behavioral risk as well as risks to employability, economic well being, and social standing and risks of civil and criminal liability.

31. Other Important Definitions • Anonymousmeans that no one, including the researcher, can identify the participant directly, through demographic or other identifiers, through a voice recording, or through a code list that links the participant’s identity with his/her data • Confidentialmeans that identifiable information from or about a participant that is maintained by the researcher is protected from unauthorized or accidental disclosure

32. Other Important Definitions • De-identification means removing personal identifiers from confidential data after collection, allowing the data to be maintained indefinitely without risk of breach of confidentiality. De-identification techniques include: • Destruction of the code list that links the participant identities with their data • Removal and destruction of the portions of written data collection tools that include identifiers • Destruction of audiotapes after transcription in which pseudonyms that are not linked to participant identity through a code list are used • Destruction of videotapes after recorded behaviors are coded if there is no code list that links coded behaviors to participants’ identities

33. When 45 CFR 46 Doesn’t Apply • When the proposed project does not involve research as defined by Federal regulations and the VSU IRB • Oral history projects • “Action research” to improve teaching of College of Education students • Use of de-identified or publicly available archival data • Most student projects completed as class assignments to learn methods • When the subjects of the research are deceased …but consider possible third party protection • When there is no intervention or interaction with the individual and no private data or information will be obtained or recorded in such a manner that it can be associated with the individual (includes observation of public behavior) …but consider expectation of privacy No application required.

34. Student Research Not Subject to IRB Oversight • Projects that are conducted and presented solely within the confines of the college classroom or departmental “subject pool” that are • A general course requirement; • Intended solely to develop the student’s research skills; and • Will be overseen by a faculty member • Projects intended primarily to teaching research methods that are conducted outside the college classroom or subject pool, provided they do not • Involve minors; target vulnerable populations; or pose risk of physical harm to pregnant women or fetuses; • Deal with a personal or sensitive nature unless data are collected anonymously; or • Involve any activity that would place participants at more than minimal risk • “Action research” conducted by College of Education students in their own PK-12 classrooms for the purpose of improving teacher practice

35. Student Research Subject to IRB Oversight • Investigative activities that meet the IRB’s definition of research (“systematic investigation…designed to develop or contribute to generalizable knowledge”) • Other investigative activities involving humans if they • Are undertaken with the intent to produce results that will be submitted for peer-reviewed publication or presentation; • Include minors, target a vulnerable population, or place pregnant women and/or fetuses at risk of physical harm; • Deal with a topic of a sensitive or personal nature in a way in which anonymity cannot be sustained and the examination or reporting of participant responses or behavior may be potentially stigmatizing or may place the participant at more than minimal risk physically, psychologically, socially, or economically or for civil or criminal liability; • Involve any other type of activity that places the participants at more than minimal risk, considering both the probability and the magnitude of harm.

36. Exemptions from 45 CFR 46 • Some research involving human participants is exempt from IRB review • Risk must be minimal and • Research must meet at least one exemption criterion listed in 45 CFR 46 • IRB has delegated exemption authority to the IRB Administrator (Director of Office of Sponsored Programs & Research Administration) • Except exemption of IRB members’ protocols which are determined by the Chair • Questionable protocols are referred to the IRB Chair for determination

37. Exemption Categories • Category 1: Research conducted in established or commonly accepted educational settings, involving educational practices, such as • Research on regular and special education instructional strategies • Research on effectiveness of, or comparison among, • Instructional techniques • Curricula • Classroom management methods

38. Exemption Categories • Category 2: Research involving • Educational tests (cognitive, diagnostic, aptitude, achievement) • Survey procedures • Interview procedures or • Observation of public behavior unless • Information is recorded in such a way that participants can be identified directly or through identifiers and • Disclosure could reasonably • Place participant at risk of criminal or civil liability or • Be damaging to financial standing, employability, or reputation

39. Exemption Categories • Special notes on Category 2 • Exemption for survey and interview procedures does not apply to research involving children • Exemption for observation of public behavior does not apply to research involving children except when the investigator does not participate in the activities being observed

40. Exemption Categories • Category 3: Research involving • Educational tests (cognitive, diagnostic, aptitude, achievement) • Survey procedures • Interview procedures or • Observation of public behavior that is not exempt under Category 2 if • Participants are elected or appointed public officials or candidates for public office or • Federal statute requires without exception that confidentiality of the personally identifiable information be maintained throughout the research and thereafter

41. Exemption Categories • Category 4: Research involving collection or study of existing • Data • Documents • Records • Pathological or diagnostic specimens if • The sources are publicly available or • Information is recorded by the investigator in such a manner that participants cannot be identified directly or through identifiers linked to the participants

42. Exemption Categories • Category 5: Research and demonstration projects that are mandated by federal statute and are designed to study, evaluate, or otherwise examine: • public benefit or service programs; • procedures for obtaining benefits or services under those programs; • possible changes in or alternatives to these programs or procedures; or • possible changes in methods or levels of payment for benefits or services under those programs, unless there is a specific requirement for IRB review in the statute and provided the project does not involve significant physical invasions or intrusion upon the privacy of the participants. (Note: This category is not applicable to evaluation of most federally funded programs, nor is it applicable to any state or local government funded programs or those supported by a non-profit organization.)

43. Exemption Categories • Category 6: Taste and food quality evaluation and consumer acceptance studies if the food to be consumed • Is wholesome and additive-free • Contains an ingredient at or below the level, and for a use, found to be safe or • Contains an agricultural chemical or environmental contaminant at or below the level found to safe by the FDA or approved by the EPA or the USDA

44. Notes About Exemption • Written informed consent is generally not required or recommended for exempt protocols • If written consent is desired by the investigator to meet professional standards, the IRB provides specific language for inclusion regarding participants’ rights • The IRB may recommend a consent script to be read to participants being interviewed • The IRB may recommend a written explanation including consent elements to accompany written surveys

45. Research Requiring IRB Review • Research involving receipt, possession, or release of private information that is individually identifiable, either directly or through coding systems • Research involving manipulation of the participant’s environment • Controlling light, sound, or temperature • Presenting sensory stimuli • Orchestrating environmental events or social interactions • Making voice, digital, or image recordings

46. Research Requiring IRB Review • Research involving invasive or non-invasive procedures • Collecting biological specimens • Taking physical measurements • Utilizing physical sensors • Dispensing drugs • Administering treatments • Employing medical technologies

47. Types of IRB Review • Some research qualifies for “Expedited Review” • Must be minimal risk research and • Must meet federal criteria for expediting • Remaining research must receive a “Convened Review”

48. Expedited Review • Review is done by two-member expediting team (IRB Chair or Vice-Chair may individually expedite in emergency) • Approval is subject to full IRB concurrence at next convened meeting • Expediters may recommend convened review

49. Expedited Review Process • IRB Administrator conducts pre-review of application and consults with researcher regarding suggested revisions • Application is sent to expediting team for review • Team members communicate with each other via email (with cc: to IRB staff) while conducting review • Team takes action, with team leader responsible for communication with IRB Administrator • Requests revisions as necessary • Approves protocol and completes approval report • Refers for convened review Team members should not correspond directly with researchers. All requests for information/clarification should be made through the IRB Administrator to keep the identity of reviewers confidential.

50. Expedited Review Categories • Categories that are not often used at VSU • Category 1: Clinical studies of approved drugs and devices that are used as approved • Category 2: Collection of blood samples (limited amounts) • Category 3: Non-invasive collection of biological specimens (hair, nail clippings, etc.)