Download - Institutional Review BoardValdosta State University RESEARCH ETHICS Orientation for IRB Members Session 1: The Regulations and the Role of The IRB Presented

Institutional Review BoardValdosta State University

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


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


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


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


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


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


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


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)?


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


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


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


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


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


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


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


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


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


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


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.


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


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.


CITIProgram.org Training for Researchers

Basic Course1. Introduction2. History and Ethical Principles – SBR3. Defining Research with Human Subjects – SBR4. The Regulations and the Social and Behavioral Sciences – SBR5. Basic Institutional Review Board (IRB) Regulations and Review Process6. Assessing Risk in Social and Behavioral Sciences – SBR7. Informed Consent – SBR 8. Privacy and Confidentiality – SBR9. VSU Module

(SBR = Social and Behavioral Research)


CITIProgram.org Training for Researchers

Additional Required (?) Modules Based on Research Design1. Research with Children - SBR2. Research in Public Elementary and Secondary Schools - SBR3. Vulnerable Subjects – Research Involving Pregnant Women and Fetuses in utero4. Research with Prisoners - SBR5. Research with Protected Populations – Vulnerable Subjects: An Overview6. International Research7. Group Harms: Research with Culturally or Medically Vulnerable Groups8. Records-Based Research9. Genetic Research in Human Populations10. HIPAA and Human Subjects Research (personal medical information)11. Internet Research - SBR12. Workers as Research Subjects – A Vulnerable Population


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


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


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

See handout on qualitative and quantitative 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


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)


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


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.


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


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


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



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



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



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



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.)



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 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


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


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”


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 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.


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.)


Expedited Review Categories 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;


Expedited Review Categories Category 4: Collection of data through non-invasive procedures

(continued): 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.)



Category 5: Research involving materials such as Data Documents Records Specimens

that have been collected, or will be collected, solely for non-research purposes, such as Medical diagnosis and/or treatment Education Employment



Category 6: Collection of data from Voice recordings Video recordings Digital recordings Image recordings

made for research purposes


Expedited Review Categories Category 7: Research on individual or group characteristics or behavior,

including, but not limited to, research on Perception Language

Cognition Communication

Motivation Cultural beliefs or practices Identity Social behavior

or research employing the following methods: Survey Program evaluation Interview Human factors evaluation Oral history Quality assurance Focus group



Category 8: Continuing review of research approved in convened IRB meeting if Enrollment is permanently closed All research-related interventions are completed and The research remains active only for long-term follow-up of

participantsor No participants have been enrolled and no additional risks have

been identified or

Only data analysis remains



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


Convened Review 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 For modifications only during the current protocol approval

period

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 Referred for Convened Review if

Original review was convened and Criteria for expedited review not met


Combo Mod and Continuation Requests For combination of protocol modification request and continuation

review Handled like a Protocol Modification Request


Is this research subject to IRB oversight?

Is this research exempt from IRB

review?Does this research qualify

for expedited review?

Aaaagggghhh!!! What do I do?

Relax! The IRB Administrator routes applicationsand requests according to federal criteria.

Thoroughly Confused?Who reviews this

protocol modification request?


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

Informed consent 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


Required Elements of Consent Identification and affiliation of the researcher A statement that study involves research An explanation of purpose of research 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


Required Elements of Consent

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


Required Elements of Consent Statement that

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.


Additional Elements of Consent

As appropriate (usually for greater than minimal risk research)… Statement regarding possibility of unforeseeable risks Any additional costs to the participant 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 assentverbally 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.


Waiver of Written Consent

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.


Waiver of Written Consent

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(Assuming complete request or application)

Exemption Request: 1-5 working days Expedited Review: 5-10 working days 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 - Institutional Review BoardValdosta State University RESEARCH ETHICS Orientation for IRB Members Session 1: The Regulations and the Role of The IRB Presented

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