Indonesia Inquiry

National and International Protocols for Institutional Review Board (IRB)

January 24, 2012 Research Resources 0

 

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
Additional research information is included for select organizations, legislation, regulations, and guidelines (2015). For instance, the Office of Human Research Protections (2015) lists three types of research for Indonesia: 1) General, 2) Drugs and Devices, 3) Human Biological Materials. Each of these categories has information on organizations and regulations such as the National Guidelines on Ethics in Health Research and the National Guidelines on Use of Stored Biological Materials. There is no information listed for Indonesia regarding the Social Sciences, however.
The amount of research resources and regulations on human subjects differs in every country. This can be exemplified through two countries: The United States of America and Indonesia. The Office for Human Research Protections (2015) lists three areas of research for Indonesia whereas the United States lists all seven. Despite this difference, the document also lists a human subject protective agency for both countries. The protective agencies in both countries are imperative to research because they prioritize the rights and wellbeing of the individuals who participate in studies and help provide significant results and findings.
The document, “International Compilation of Human Research Standards” by the U.S. Department of Health and Human Services is a document that addresses the protocols and guidelines for the natural sciences. The document can be found in the attachment below:
References
2015. “Institutional Review Board: Collaborative Institutional Training Initiative
             (CITI).” Texas A&M University-Corpus Christi. September, 10.
2015. “Regulations.” U.S. Department of Health and Human Services.   
            September, 9. http://www.hhs.gov/ohrp/humansubjects/index.html
Bachman, Ronet, and Schutt, Russel K. 2014. The Practice of Research in
            Criminology and Criminal Justice. 5th ed. Washington, DC: SAGE.
Bailey, Lisa Robinson. 2014. “History and Ethical Principles.” Collaborative
              Institutional Training Initiative at the University of Miami. September, 11.
Office for Human Research Protections. 2015. “International Compilation of Human
             Research Standards.” U.S. Department of Health and Human Service.
             September, 9. http://www.hhs.gov/ohrp/international/index.html

Here are some links to get you started in obtaining a research permit in Indonesia: