What Are IRB Protocols?

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An Institutional Review Board (IRB) is a committee within an organization charged with compliance to federal and institutional regulations of research involving human subjects. The IRB reviews a document called an IRB Protocol that is developed and submitted by the researcher. In order to ensure compliance, the IRB oversees the research process through scheduled meetings, reviews various aspects of the proposed research and grants conditional approval.

Federal Compliance

  • While institutional requirements may vary, compliance must meet federal standards. The Department of Health and Human Services (HHS) specifies these requirements in Codes 45 and 46. The IRB must examine the protocol and accompanying documentation to determine that it is in compliance.

Introduction, Hypothesis and Rationale

  • While institutions have individual requirements and formats for protocols, this is a document with multiple sections demonstrating compliance with ethical treatment of human research subjects. The introduction must contain a reason for performing the study. The hypothesis must contain a testable statement related to the research. The scientific rationale must explain why the study should be done.

Subject Selection, Participation and Recruitment

  • The protocol must contain criteria for subject selection. This criteria must explain the basis for exclusion of subjects. The research should include members of both genders and minorities so as to reflect the groups' proportion in the general population unless there is a compelling reason for exclusion of a particular group. Criteria for subject withdrawal from the study must be included. The method of recruitment for subjects must be included. Any recruitment material should be included in the supporting documents.

Risks and Benefits

  • The IRB must contain detailed information about potential benefits and risks. A risk is defined as probable harm. A benefit is defined as a desired outcome. Risks must be minimized and proportionate to the benefits. The IRB is responsible for weighing the risks and benefits. Risks can include physical and psychological harm. Invasion of privacy, economic and social consequences and breach of confidentiality are also considered risks.

Confidentiality and Data Storage

  • The researcher should set forth procedures in the protocol for maintaining subject confidentiality when appropriate. This includes whether subject identity will be specified by codes and whether files will be locked. The researcher must specify what the data will be used for and if the data will be made available to other researchers. The protocol must specify the type of analysis methods that will be used with the data including manipulations and statistical methods.

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