National and International Protocols for Institutional Review Board (IRB)
National and International Protocols for the International Review Board (IRB)
Compiled by: Stephanie Razo
Directed Individual Study, Fall 2015
Texas A&M University-Corpus Christi
The Institutional Review Board (IRB)
There are many regulations and protocols that a researcher must consider when preparing their research proposal. The proposal must abide by the research standards set by the Institutional Review Board (IRB). The Institutional Review Board is an institutional committee that reviews, approves, and monitors any type of research that involves human beings (Bachman and Schutt 2014). The Institutional Review Board is responsible for reviewing research proposals and ensuring that they protect the rights of the human subjects who will participate in that particular research. The rights that the IRB intends to protect include a subject’s wellbeing, autonomy, and privacy (Bailey 2014).
The IRB in the United States
Most countries and their research institutions have an Institutional Review Board that will review the research proposals that are submitted by professors and students at that particular research center. The Institutional Review Board in the Unites States is federally regulated by the Office for Human Research Protection under the United States Department of Health and Human Services (2015). The protocols and responsibilities of the IRB are listed under the Title 45 Part 46 of the Code of Federal Regulations, most commonly referred to as the 45 CFR part 46 (2009). The Institutional Review Boards at all of the universities and research centers across the United States musts abide by Title 45 Part 46 of the Code of Federal Regulations.
The IRB at Texas A&M University-Corpus Christi
In addition to the IRB committee members being familiar with 45 CFR part 46, researchers at all universities are required to undergo a training where they will be exposed to the protocols of the IRB as well as 45 CFR part 46. For instance, Texas A&M University- Corpus Christi is one of many universities within the United States that has an Institutional Review Board for their researchers. In order for researchers and students to begin working on a research project that will involve human subjects, they must first complete the Collaborative Institutional Training Initiative (CITI) Human Subject resource course ( http://research.tamucc.edu/compliance/irb_citi.html ). This training requirement at Texas A&M University- Corpus Christi went into effect on January 1, 2011 (Texas A&M University- Corpus Christi).
The IRB and International Research
There are also guidelines for researchers who are interested in conducting a study outside of the United States. The researcher will have to follow the standard procedures instituted by the United States as well as the rules and regulations established by the other country. In order to guide researchers who are interested in conducting a study abroad, the Office for Human Research Protection has drafted the “International Compilation of Human Research Standards” (U.S. Department of Health and Human Services 2015). The “International Compilation of Human Research Standards” is a document that explains the research laws and regulations for 113 countries. The document organizes each country’s profile in a table where the rows represent the type of research being conducted such as the following:
- General Research
- Drugs and Devices
- Privacy/Data Protection
- Human Biological Materials
- Genetic Research
- Embryos. Stem, Cells and Cloning
Here are some links to get you started in obtaining a research permit in Indonesia:
- Kementerian Negara Riset dan Teknologi (RISTEK, Ministry of Research and Technology): http://www.ristek.go.id/
- PDF Explaining Application Procedures: http://www.ristek.go.id/?module=File&frame=lain_lain/frp/PANDUAN_frp_English.pdf
- Foreign Research Permit – Online Application: http://frp.ristek.go.id/