National Research Act
The National Research Act, passed by Congress in 1974, established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The purpose of the Commission is to ensure that the rights and well-being of human subjects involved in research are protected. Therefore, any institution that engages in or supports research must establish an Institutional Review Board (IRB) for the purpose of approving and monitoring research according to Federal Policy such that human subjects are protected during all phases of the research process.
The Belmont Report
The Belmont Report, published by the Commission in 1974, is a statement of fundamental ethical principles and/or guidelines for investigators who conduct research using human participants or subjects. The Belmont Report distinguishes between practice and research, defines basic ethical principles (the Belmont Principles) as they apply to research involving human subjects, and provides guidelines in the application of those ethical principles. There are many instances in which practice and research overlap. External and objective review of protocols is required only when human subjects are used in some aspect of research. The IRB at GCU bases all decisions on approval of research protocols according to the Belmont Principles.
Application of the Belmont Principles
- Informed Consent - Providing opportunity for individuals to choose what shall or shall not happen to them; upholds the principle of respect for persons.
- Risk/Benefit Analysis - A balance between the risk to a human subject and the benefit gained from the research; establishes the beneficence of research on human subjects.
- Selection of Subjects - Researchers must exhibit fairness by avoiding preference among individuals or social biases in support of justice in human subject-based research.
Research Ethics Training
It is GCU policy that all researchers successfully complete research ethics training prior to applying for IRB approval. The CITI (Collaborative Institutional Training Initiative) training program involves web-based instruction in the ethics of research with human subjects. CITI Training is free to GCU doctoral learner and faculty. Researchers must submit completion reports for the Basic Research Course for Social and Behavioral Sciences or Biomedical Research and the Responsible Conduct of Research Course as part of the IRB application. Training certification remains in effect for five years. Click here to register and begin this training.
Office of Human Research Protection
The Department of Health and Human Services (DHHS), through its Office of Human Research Protections (OHRP), is tasked with providing guidelines, education, and registration of an IRB. The IRB at Grand Canyon University is registered with the OHRP and has gained the status of Federal-wide Assurance, which assures that the GCU community of researchers abides by the Code of Federal Regulations, Title 45, Part 46 (45.CFR.46) and is therefore eligible to apply for and potentially conduct federally funded research on human subjects.
For Research Participants
Research volunteers have a special set of rights that apply when participating in research. To help determine if volunteering as a research participant is right for you, please read the Office for Human Research protections (OHRP) brochure Becoming a Research Volunteer.
If you have you been contacted by a Grand Canyon Researcher to participate in a study and have questions or concerns, please contact the Office of Research and Dissertations at firstname.lastname@example.org.
Please visit the Federal Office of Human Research Protection for more information on ethics in research, including policies and procedures.