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

Federal RegulationsPresented by the
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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)
of Biomedical and Behavioral Research established
1979: Belmont Report issued; ethical principles defined
1980: FDA regulations for testing of new drugs and devices codified
Institutional Review Board
Valdosta State University
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
established
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
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
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
Sampling methods
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
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)?
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
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
Minimize harm to participants
Carefully balance risks and benefits to the participants
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
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
Establishes oversight of federally funded human research
Establishes Institutional Review Boards (IRBs) for the protection of human research participants
Establishes institutional assurance mechanism
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
VSU’s FWA
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
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
Serious or continuing non-compliance with regulations or IRB policies
Suspension or termination of protocols
The Institutional Review Board (IRB)
Mandated to safeguard the rights and welfare of research participants by
Reviewing research protocols
Approving or disapproving protocols
Ensuring or waiving informed consent and/or documentation of informed consent
Conduct continuing review of research
Constitution of IRB
Different professions
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
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.
Faculty members
In a community setting
In a foreign country
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.
IRB Educational Resources
CITIProgram online tutorial
VSU website
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
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Research with Children - SBR
Vulnerable Subjects – Research Involving Pregnant Women and Fetuses in utero
Research with Prisoners - SBR
International Research
Records-Based Research
HIPAA and Human Subjects Research (personal medical information)
Internet Research - SBR
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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.
Federal Definitions
Research is 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
Federal Definitions
Human Participant is a living individual about whom the investigator obtains
Data through intervention or interaction with the individual and/or
Identifiable private information
Manipulation of the participant
Interaction includes
Direct communication with the participant (such as interviewing or conducting a focus group)
Interpersonal contact with the participant (such as surveying)
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
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.
Other Important Definitions
Anonymous means 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
Confidential means that identifiable information from or about a participant that is maintained by the researcher is protected from unauthorized or accidental disclosure
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
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.
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
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.
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
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
Survey procedures
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
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
Survey procedures
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
Data
Documents
Records
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
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.
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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
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
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
Collecting biological specimens
Taking physical measurements
Utilizing physical sensors
Remaining research must receive a “Convened Review”
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
Expedited Review Process
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
Refers for convened review
Administrator to keep the identity of reviewers confidential.
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.)
Category 4: Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Such procedures include, but are not limited to:
Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy;
Weighing or testing sensory acuity;
Magnetic resonance imaging;
Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; and
Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
(Note: Medical devices employed must be cleared/approved for marketing.)
Data
Documents
Records
Specimens
that have been collected, or will be collected, solely for non-research purposes, such as
Medical diagnosis and/or treatment
Voice recordings
Video recordings
Digital recordings
Image recordings
Category 7: Research on individual or group characteristics or behavior, including, but not limited to, research on
Perception Language
Cognition Communication
Identity Social behavior
Survey Program evaluation
Category 8: Continuing review of research approved in convened IRB meeting if
Enrollment is permanently closed
The research remains active only for long-term follow-up of participants
or
No participants have been enrolled and no additional risks have been identified
or
Category 9: Continuing review of research to which Expedited Review Categories 2 through 8 do not apply if the IRB has documented at a convened meeting that risk is minimal and no new risks have been identified
Initiated when research is not exempt or cannot be expedited
(e.g., when risk is more than minimal or the research involves prisoners)
Requires review by a quorum of IRB members in a face-to-face meeting
Majority of members must be present
(Alternate members may serve as specifically assigned proxies)
A non-scientist must be present
For research involving prisoners, the Prisoner Representative member must be present and special review criteria are considered
A majority of those present must approve the protocol
OHRP now allows review via teleconferencing or other electronic means provided all members have opportunity for input and exchange
Protocol Modification Requests
Expedited review by team if
Original review was expedited and no changes are proposed that
Will increase the level of risk to “more than minimal” or
Will make expedited review categories no longer applicable
Original review was convened but
The IRB has documented at a convened meeting that risk is minimal and no new risks have been identified
Continuation Requests
For continuation of protocol approval without any proposed changes for up to twelve additional months
Expedited by Chair or Vice-Chair if
Original review was expedited or
Original review was convened but
Enrollment is permanently closed; all research-related interventions are completed, and the research remains active only for long-term follow-up of participants; or
No participants have been enrolled and no additional risks have been identified; or
Only data analysis remains
Criteria for expedited review not met
For combination of protocol modification request and continuation review
Handled like a Protocol Modification Request
Aaaagggghhh!!! What do I do?
Relax! The IRB Administrator routes applications
and requests according to federal criteria.
Thoroughly Confused?
IRB Review Criteria
Risks to participants are minimized
Risks to participants are reasonable in relation to anticipated benefits to the individual and/or society
Selection of participants is equitable
Adequate preparation is taken to protect privacy and confidentiality of participants
IRB Review Criteria
is sought from each prospective participant or legally authorized representative
is documented (unless research is exempt or waiver of documentation of consent is granted by IRB)
Adequate provisions are made for ongoing monitoring of participants’ welfare
The expected duration of participant’s involvement in the study
A description of study procedures
Identification of the experimental procedures
A description of reasonably foreseeable risks or discomforts to participant—those that are minimal and/or those that are more than minimal
A description of any benefits which may reasonably be expected for the participant or for society
Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant
Statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained
An explanation of any costs associated with participation
An explanation of any compensation for participation
For research involving more than minimal risk, an explanation of any medical treatments available if injury occurs, what treatments consist of, and where to obtain further information
Participation is voluntary
Refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled
Participant may discontinue his/her participation at any time without penalty or loss of benefits to which he/she is otherwise entitled
Name of contact persons to ask questions about the research, to ask questions about research participants’ rights, and to report research-related injuries or other adverse events
All these elements are included in the IRB’s Model Consent Form.
research)…
Circumstances that may require participant’s termination
Consequences of a decision to withdraw
Procedures for orderly termination
Statement that significant new findings that may influence the participant’s willingness to continue in the study will be provided
Written Consent Requirements
Researcher must follow IRB Model Consent format
Form must contain all elements or must indicate that all elements were given orally with witness present
From must include IRB approval stamp
Form must be signed by participant or his/her legally authorized representative
Participant must receive a copy
IRB may audit a research project to determine compliance with informed consent requirements
Documentation of Consent
If research participant is a minor…
And the child is too young to agree or refuse to participate in the research, secure parent/guardian permission
And the child is old enough to agree or refuse to participate, secure parent/guardian permission and the child’s assent (written or verbal)
A signature line for the child may be added to the parent/guardian permission form
Note: Even very young children have some capacity to give assent
verbally or through their actions.
A Note on Terms
Consent is sought from adults who have the capacity to understand and act for themselves
Permission is sought from parents or guardians of minors or other adults who do not have the legal standing or capacity to understand and act for themselves
Written Assent is sought from older children (usually cognitive age of 12-14 years)
The IRB also provides model permission and assent forms for researchers.
The IRB may waive the requirement for written (signed) consent
When the consent form is the only record linking the participant to the research and potential harm could result from breach of confidentiality
When the research presents no more than minimal risk and involves no procedures for which written consent is normally required outside the research context
An application attachment form for request for waiver of documentation of informed consent is in development.
In lieu of written consent, the IRB may require
Presentation of a written statement that includes the elements of consent but does not have a signature line to participants
Oral explanation of consent elements using an approved script
Other IRB Consent Options
May approve consent procedure which alters or waives some or all of the elements of informed consent if
The study is government sponsored and examines a public service/benefit program
The research could not practicably be carried out without alteration or waiver of informed consent
The research involves no more than minimal risk
The alteration or waiver will not adversely affect participants’ rights or welfare
Pertinent information is provided to participants after their participation, if appropriate
The alteration or waiver does not conflict with other federal, state, or local laws
An application attachment form for request for alteration or waiver of
informed consent is in development.
Consent Process Approval
When written informed consent is required, the IRB will place a dated approval stamp on the consent form. This form is returned to the researcher to be used as a copy master.
When a written explanation of consent elements or a script to be delivered orally is approved by the IRB, the researcher may not make changes to the approved procedure without IRB authorization.
When written consent is not required and the participant has been fully informed with a witness present, his/her willingness to participate implies consent.
Additional Protections for Prisoners
45 CFR 46, Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Recognizes that prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate in research
Provides additional safeguards for the protection of prisoners
Targeted Processing Time
Convened Review:
Must be submitted by posted deadline (10 days before meeting)
Will be reviewed at next regular meeting
(IRB meets monthly except in December, June, and July)
Notification of approval or request for revisions provided in 1-5 working days after IRB meeting
Special meetings possible but discouraged

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

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