Understanding Institutional Review Board Application Process: Human Subjects Research
Many research projects involve human subjects. Most institutions have an Institutional Review Board to ensure that research projects at the institution are in compliance with regulations for research that includes human subjects. When you are conducting a research project, you are required to submit an application for review to the IRB at your institution and receive approval before beginning the research project. Funders will ask about IRB approval when you submit an application, and you will be required to show a letter of approval by the time a grant is funded. It is important to understand how to prepare your IRB review application.
Basically, the purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in your research. Review boards use a panel process to review your research protocols and related materials to ensure that human subjects are protected. A typical IRB review application includes the following sections.
What is principal investigator information?
You will be asked to name the principal investigator (PI) and describe their qualifications and relevant experiences. Most of the time, you will also attach a copy of the PI vitae. If you are a student, or non-faculty researcher, acting as the principal investigator, you will generally need a faculty sponsor to approve.
What procedures are involved to carry out research study?
This section should be used to describe research procedures in detail and usually involves responding to a series of questions. The questions will include:
1. What is the overall goal of your study and what are your specific objectives?
2. What will you do?
3. What will the subjects do?
4. A list of the steps in your study is often helpful. It is important that you describe your research protocol in enough detail so that an uninformed reader can understand what is involved in your research project.
Individuals who will participate in your study
You should include details such as the age range, gender, and ethnic background of the participants. You should also include any other characteristics that make your subjects identifiable. There are protected classes of subjects and you will be asked whether your research study involves any of these protected classes. Examples of protected classes include pregnant women, children under the age of 18 years, individuals with disabilities, and prisoners.
Data you will collect and how you will collect these data
This section should include details of all the research instruments that will be used in your study and you will be asked to provide copies of these instruments with your application. You will also be asked to describe how the information derived from the data you collect will be used. Finally, you will be asked to include details about what will happen to the data you collect once the study ends. A key part of this section requires an explanation of how the confidentiality of subjects and their data will be maintained. If your study deals with a sensitive issue, you will need to provide a clear statement regarding the precautions that will be taken to minimize risks. Describe how you will prevent violating the confidentiality of the subjects involved in your study.
Procedures for subject involvement in your study
This section will include details of how you plan to recruit subjects and how long they will be involved in the study. In addition, you will be asked about how you plan to obtain informed consent for participation in the research study. Obtaining informed consent is required for IRB approval and the board will want to see exactly how you will approach this issue. You will need to describe the subjects from whom you will obtain consent and let the board know what information on your research study will be given to subjects. In the United States, federal regulations mandate that if a research study involves subjects under 18 years of age, consent must be obtained from the parent or legal guardian and from the child. You should develop and submit the content forms you will use with your application. There are examples of informed consent forms available online that you can use as a guide. For example, here is a link to an Informed Consent Form Template from Trinity College Dublin, Ireland. Remember, when developing forms for children, you should use age-appropriate language.
Benefits or risks of participating in the study
You will be asked to explain any potential benefits or risks to subjects from participating in the study. You should explain how likely it is that these risks will occur and the impact if they do. Where appropriate, state how you will ensure that your subjects receive necessary medical or professional intervention if they suffer any negative effects because of your intervention. Explain how you will ensure the safety of your subjects during the research project. Also explain how any risks are balanced by the benefits to be gained by the subjects from their participation in your research project.
In general, there are three types of IRB review. These are Exempt Review, Expedited Review, and Full Review. If proposals involve no greater than a minimal risk, they are deemed exempt from certain regulations. Examples include studies that involve benign interventions and secondary studies that use identifiable information that is already publicly available. Studies that involve minimum risk, but do not meet the criteria for exempt status can be considered for expedited review. If a research study does not qualify for exempt status or expedited review, they need to go through the full review process. The timeline for review can take some time to complete and is based on the calendar for IRB meetings. Studies deemed exempt move quickly through the process and those needing full review take the longest.
A number of questions guide review boards in reviewing proposals and generally include the following:
✦ Are the risks to human subjects reasonable in comparison to benefit and are those risks minimized?
✦ Is the study well designed?
✦ Is the selection of subjects fair?
✦ Has the informed consent process been clearly articulated and is it appropriate?
✦ Does the research study comply with required special considerations for vulnerable populations, for example, children?
✦ Will subjects’ privacy be protected?
✦ Is there a clear plan for keeping data confidential and destroying data when appropriate?
Generally, an IRB approves protocols one year at a time. For multi-year projects, the lead investigator will need to submit an application for approval for each year of the project. If any changes are made to the study during an approved year the investigator must submit an application to the IRB listing these changes. Because of the length of time taken to process applications, researchers should submit an application for approval as soon as they can. Once a grant award is made, IRB approval needs to be in place before the funder releases the funds to the institution.
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