Historical Perspective : Institutional Review Boards (IRB’s) were created as a result of past abuses of the human research process. Even after the Nuremburg Code, which addressed the ethics of research and informed consent, unethical practice in research continued. An example was the Tuskegee Syphilis Study (1932 – 1972). In this study, the investigators withheld medical treatment to African-American men with syphilis after treatment became available.
These abuses demonstrated the need for an ethical guideline for human research protection.
These ethics were outlined in the Belmont Report of 1979 , which provided guidance for legislation,
(Perlman, 2004). The Protection of Human Subjects Law (45 CFR and 21 CFR 50 & 56) was signed into law in 1981 Researchers could no longer decide for themselves if their studies were ethical or not. Now an IRB would make these decisions.
The Institutional Review Board (IRB): An IRB is a group of people who oversee research. This group is made up of scientific, non-scientific, professional and lay persons from the community, who are not associated with the studies being reviewed. The purpose of an IRB is to ensure protection of the rights and welfare of clinical trial participants. An IRB has the authority to approve, require modifications or disprove research, (45 CFR 46.109(a)). No study treatment or informed consent can take place until the protocol has full IRB approval. Institutional administration cannot dictate or overturn the decisions of an IRB.
Protocol Review: Prior to IRB submission of a protocol there are several reviews that may take place.
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Scientific Review Committees: At larger institutions a scientific review may take place prior to IRB submission. This is required for all NCI-designated Cancer Centers. The committee evaluates the study for scientific merit, and feasibility at their specific site. If the committee approves the study, then it is submitted to the IRB. Smaller institutions may not have a scientific review committee, but there should be a mechanism in place to evaluate if the study is feasible & is acceptable scientifically at the institution.
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IRB Review: The Institutional Review Board reviews research from an ethical stand point to assure that patient’s rights and welfare are protected. Institutions within the National
Clinical Trial Network (NCTN) are required to utilize the Central IRB , of the National Cancer
Institute. For other projects the IRB of record for the institution can be used.
Federal Wide Assurance : Every institution that conducts federally funded research must:
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Utilize an IRB that is registered with the Office for Human Research Protection (OHRP)
(Trocky, 2013 & 21 CFR 56.106).
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Sign a Federal Wide Assurance (FWA) agreement with the Office for Human Research
Protection, (OHRP).
An assurance is a legal agreement between an institution and the government that research will be conducted in accordance with federal regulations & Good Clinical Practices (GCP). http://www.hhs.gov/ohrp/assurances/assurances/index.html
Recruitment Material: Any type of advertisement, including social networking, must be reviewed and approved by an IRB before it can be used. Advertising, is considered part of the informed consent process, and as such is reviewed with the same scrutiny.
The following is a list of IRB submission requirements, based on information from Filchner, K. &
Herman, P.B., 2008; U.S. Food & Drug Administration, 2009. For further information, refer to the
Code of Federal Regulations on-line @ http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
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INITIAL REVIEW
Submit the following:
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 IRB specific application
 Full Protocol
 Consent
 Recruitment material
Investigators Brochure
List of Key Personnel & Responsibilities
Means of patient identification
Study specific patient tools
IRB looks at:
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Minimized & reasonable risks
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Sound Research Design
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Equitable selection of subjects
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Informed consent
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Adequate provisions for data monitoring
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Adequate provision to protect privacy
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Vulnerable populations
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Other information specific to local rules and regulations
EXPEDITED REVIEW
An expedited review may be used in the following circumstances.
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Involves no more than minimal risk.
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Minor changes in previously approved projects, provided the project has been reviewed and approved within the past 365 days
It is the IRB that ultimately determines the review type for an initial protocol or protocol amendment.
Expedited Adverse Event Reporting (AKA: Serious Adverse Event (SAE)/Adverse Drug
Reaction (ADR)
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Expedited reporting of adverse events will be required of IRB’s. Check with your IRB for the specific requirements.
INFORMED CONSENT DOCUMENT
Informed consent is a process and should be affirmed throughout the course of treatment (e.g. at each visit). Each consent should have a version and expiration date. Most IRBs stamp the consent with this information or include it in the footer. Each IRB will have an Informed Consent Document template. Check with your IRB for the specific requirements. The NCI sample template can be used as a guide: Consent template available @: http://ctep.cancer.gov/guidelines/templates.html
.
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Informed Consent Document: Regulatory requirements:
Consent recommendations:
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Lay language
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Avoid words with > 3
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 syllables.
< 8 th grade level
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12 – font
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L-justified, R-Ragged
Dates: Initial review, revisions, expiration
Approval date by IRB
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Line in footer for subject to initial each page
8 required elements
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Involves research
Risks
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Benefits
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Alternatives
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Confidentiality
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Compensation & med. Tx for injury
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Contact info.
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Voluntary
6 Additional elements
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Unforeseeable risks
(embryo/preg.)
Circumstances for subject study termination.
Costs
Consequences of withdraw
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Additional findings communicated to patient.
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# of subjects
Reading level can be calculated in MS Word. Click the Review tab, and then click Spelling &
Grammar . Click Options . Under When correcting spelling and grammar in Word, check show
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readability statistics . Then click OK.
(This varies depending on the version of MS Word being used)
CONTINUED REVIEW
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Requirements vary with each individual IRB
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Must at least be reviewed annually (< 365 days) per the regulations o Higher risks
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Some examples of information to include in report: o # of subjects registered, locally and nationally o S ummary of subject’s experiences o # of withdrawals, and reasons o Any interim results or new information if available o Personnel changes o Copy of the current IRB approved consent document o Deviation log/list
References:
Filchner, K. & Herman, P.B. (2008). Institutional review boards/protocol modifications. . In
Klimaszewski, A.D., Bacon, M.A., Ehrenberger, H.E., Ford, B.A.& Westendorp, J.G. (Ed.)
[Second. Ed]. Manual for Clinical Trials Nursing .(pp. 91-96). Pittsburgh: Oncology Nursing
Press, Inc.
Perlman, D. (2004). Ethics in clinical research: A history of human subject protections and practical implementation of ethical standards. SoCRA, Issue 40, 37-41.
Trocky, N. & Ness, E. (2013). Institution & IRB registration. The Monitor, 27(5), 49-52.
U.S. Food & Drug Administration (2009). Code of federal regulations ( Title 45, Part 46 ).
Washington, DC: U.S. Government Printing Office.
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