IRB

Institutional Review Board IRB

Administrative body required by the federal government to protect the rights and welfare of people who are recruited to be participants in research.

Reciprocal IRB approval

Conducting research at another institution, need to complete _______. Can review IRB proposal while its under review elsewhere.

Research

A systematic investigation, including research development testing and evaluation, designed to develop or contribute to generalizable knowledge

Nuremberg Code 1946

Resulted from US military tribunal of German physicians who conducted experients. This lead to requirements of voluntary participation, documented consent, proof of benefits that must outweigh risk.

Thalidomide tragedy 1950s

Unapproved drug taken during pregnancy to help with nausea and sleep led to deformed babies. Strict FDA regulations still in place today were proposed as a result.

Declaration of Helsinki (1964)

International standards set to protect human subjects so the risks cannot exceed benefits of humanity.
Lead to requirement of independent review board of research IRB

Tuskegee experiment (1932-72)

Low-Income african American males infected with syphilis dud not receive the known cure of disease of penicillin and observed by US public health service
- this lead to the distinctions and protections of special populations in Belmont report and National Research Act (1974)

Respect for Persons

• Individuals should be treated as autonomous agents
• Persons with diminished autonomy are entitled to protection.

Informed Consent

• Subjects, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to them
• The consent process must include three elements:
• information,
• comprehension, and
• voluntariness.

Beneficence

• Human subjects should not be harmed
• Research should maximize possible benefits and minimize possible harms.

assessment of risk and benefits

• The nature and scope of risks and benefits must be assessed in a systematic manner

Justice

• The benefits and risks of research must be distributed fairly.

Selection of Subjects

• There must be fair procedures and outcomes in the selection of research subjects

Belmont Report three basic ethical principles

1. respect for persons
2. beneficence
3. justice

all cornerstones for regulations involving human subjects

Types of Research conducted that is reviewed by IRB

psychology experiments
biomedical research
survey
observation
depth interviews
retrospective chart review
prospective chart review
chronicling lives of homeless people
education, psychological, or cognitive test
comparison of educational techniques

anonymity

Assurance that no one, not even the researcher, knows whose responses have been recorded in a study.

Confidentiality

Assurance that only the researcher knows who belongs to the data; that a third party who somehow gained access to the data would not be able to make a link between the subject and the data recorded from that subject.

Data

Anything that is observed, recorded in a study

Informed consent

Research participants should be fully informed of the procedures to which they will be exposed (or debriefed at the end if some deception is necessary in the execution of the study) and the potential risk

Maintenance of records

The University, the IRB and the Researcher must maintain appropriate records for three years after the termination of the study.

Principal investigator

faculty member ultimately is responsible for ensuring the approved protocol is followed and complying with all IRB policies. Must report any unexpected adverse effects

research instrument

This refers to the form used to collect data, such as a code sheet, a questionnaire, etc. These must be completed and included with your IRB proposal.

Research Protocol

A written description of the involvement of humans in the research project and the measures to protect them from risk. This is a
Separate document submitted with completed IRB application.

Risk

Refers to potential harm to subject as a result of the study procedures. Harm could be physical, emotional, legal, financial, or reputation, for example.

Sample

The group of individuals you will study (via survey, experiment, observation, medical chart review, etc.) that is a subgroup of a specific population (or universe).

vulnerable publics

These individuals who may be easily coerced without protections, who may not be able to provide fully informed consent, or who may be unusually affected by some research interventions (prisoners, children, pregnant women, cognitively impaired, and fetuses).

Exempt IRB Review Time

requires 2 reviewers; expect 5 working days from first business day after receipt of proposal

Expedited IRB Review Time

requires 2 reviewers, expect 5-10 working days from business day after receipt of proposal

Full IRB Review Time

requires full committee review, expect 15-20 days from first business day after receipt of proposal

Exempt Review conditions

- commonly accepted in educational settings
- education tests (diagnostics, cognitive)
- survey or interview procedures
- observation of public behavior
- collection or study of existing data, documents, records
- study to evaluate public benefit, service programs
- taste and food quality evaluation
- any other category added by department of health and human services and publish by federal register

Expedited Review Conditions

if involves more than minimal risk to subjects and one of the following:
- collection of hair, nails
- collection of excreta, external secretions (saliva, sweat)
- recording of data of subjects ≥18 yo using noninvasive procedures
- collection of blood samples not exceeding 450ml in 8 week period or twice per week and ≥18 yo while not pregnant
- collection of dental plaque, calculus
- video/audo recordings
- moderate exercise by healthy volunteers
- study of existing data, pathological specimens
- research on individual, group behavior on perception, cognition and not involve stress to subjects
- research on drugs of devices for investigational new drugs
- any category added by department of health and human services

Expedited Review Follow-up

When the expedited review procedure is used, the IRB chairperson shall inform the IRB members of the research protocols which have been approved under the procedure.

Full Review Conditions

risks to subjects are minimized, reasonable with anticipated benefits
- selection of subjects are equitable
- informed consent with legally authorized representative
- informed consent appropriately documented
- research plan makes adequate provision for monitoring data
- protect privacy of subjects and manta confidentiality