Institutional Review Board (IRB)
Institutional Review Board (IRB) is a committee responsible for reviewing and approving research proposals involving human subjects. An IRB ensures that the proposed research meets ethical and legal standards to protect the rights and welfare of the participants.
Purpose of Institutional Review Board
Some specific purposes of an IRB include:
- Ensuring that the rights and welfare of human subjects are protected. This includes ensuring that participants are fully informed about the study and have given their informed consent to participate.
- Assessing the risks and benefits of the research study. An IRB must evaluate the potential risks to participants and ensure that the benefits of the research outweigh any potential harms.
- Reviewing the study design and methods. The IRB must ensure that the study is designed in a way that minimizes risks to participants and that the methods used to collect data are ethical.
- Monitoring ongoing studies. An IRB must ensure that studies are conducted in accordance with the approved protocol and that any changes to the study are reviewed and approved by the IRB.
- Ensuring compliance with regulatory requirements. An IRB must ensure that studies are conducted in compliance with applicable laws and regulations, such as the Common Rule and the Health Insurance Portability and Accountability Act (HIPAA).
Institutional Review Board Guidelines
Here are some general guidelines that IRBs follow:
- Informed Consent: Researchers must obtain informed consent from all participants. This means that the participants must be fully informed about the study, including its purpose, procedures, risks, and benefits, and they must be given the opportunity to ask questions and decide whether or not they want to participate.
- Risk Assessment: The IRB must assess the risks associated with the research and determine whether they are reasonable in relation to the potential benefits. The IRB must also consider ways to minimize risks and protect participants.
- Confidentiality: The IRB must ensure that the confidentiality of the participants is protected. This may involve using pseudonyms, removing identifying information, or limiting access to data.
- Privacy: The IRB must ensure that participants’ privacy is protected. This may involve conducting the research in a private setting or using measures to prevent unauthorized access to participants’ personal information.
- Conflict of Interest: The IRB must ensure that researchers do not have a conflict of interest that could bias the study results. Researchers must disclose any potential conflicts of interest to the IRB.
- Review and Monitoring: The IRB must review and monitor the study to ensure that it continues to meet ethical standards. The IRB has the authority to suspend or terminate a study if it determines that it is no longer ethical or safe.
How to Get IRB Approval
Here are the general steps to obtain IRB approval:
- Determine if your study requires IRB approval: IRB approval is required for any research study involving human subjects, which includes collecting data through interviews, surveys, or experiments.
- Complete required training: Many IRBs require that researchers complete training in the responsible conduct of research and human subjects protection.
- Develop the study protocol: The study protocol should describe the research question, methodology, recruitment and consent procedures, and data collection and analysis plans.
- Submit the IRB application: Once the study protocol is developed, submit the IRB application to your institution’s IRB. The application will include the study protocol, consent forms, and any other required documents.
- Respond to any requests for revisions: The IRB may request revisions to the study protocol or consent forms before granting approval.
- Receive IRB approval: Once the study protocol is approved, you may begin your research study.
Institutional Review Board Example
Here is an example of an IRB:
Let’s say that a researcher wants to conduct a study on the effects of a new medication on patients with depression. The study would involve giving the medication to a group of patients and monitoring their symptoms over a period of several months. Before the study can begin, the researcher must submit a detailed research protocol to the IRB.
The IRB will then review the protocol to ensure that the study meets certain ethical standards. For example, the IRB will want to make sure that:
- The risks to the participants are minimized and are reasonable in relation to the potential benefits of the study.
- The participants are fully informed about the nature of the study and have given their informed consent to participate.
- The confidentiality of the participants is protected.
- The study design is scientifically sound and will yield reliable results.
If the IRB determines that the study meets these and other ethical standards, it will issue a formal approval letter. The researcher can then begin the study, but must continue to follow the protocol and report any adverse events or other issues to the IRB. The IRB may also conduct periodic reviews of the study to ensure that it continues to meet ethical standards.
Institutional Review Board Proposal Sample
Here is a sample proposal for an Institutional Review Board (IRB) submission:
Title: Effects of Meditation on Stress Reduction in College Students
Introduction:
Stress is a common issue among college students, and it can have negative effects on academic performance and overall well-being. Meditation has been shown to be an effective tool for reducing stress and improving mental health. However, the effectiveness of meditation for stress reduction in college students has not been well-studied. This study aims to investigate the effects of a meditation intervention on stress reduction in college students.
Objectives:
The main objective of this study is to determine if a meditation intervention is effective in reducing stress levels in college students. Secondary objectives include assessing the feasibility and acceptability of the intervention and exploring potential moderators of the intervention’s effectiveness.
Methods:
Participants will be recruited from a large university campus and randomly assigned to either a meditation intervention or a waitlist control group. The meditation intervention will consist of eight weekly 60-minute group meditation sessions led by a certified meditation instructor. The waitlist control group will receive the intervention after the study is completed.
Participants will complete self-report measures of stress, anxiety, and depression at baseline, post-intervention, and 1-month follow-up. Demographic information and previous experience with meditation will also be collected. Intervention participants will also complete measures of intervention satisfaction and adherence.
Data Analysis:
Descriptive statistics will be used to summarize demographic and baseline variables. Independent samples t-tests and chi-squared tests will be used to compare groups at baseline. Repeated-measures analysis of variance (ANOVA) will be used to compare changes in stress, anxiety, and depression between groups over time. Moderation analyses will also be conducted to examine potential moderators of intervention effectiveness.
Ethical Considerations:
Participants will provide informed consent prior to participating in the study. All data will be kept confidential and stored securely. The study has been approved by the university’s Institutional Review Board.
Conclusion:
This study will provide valuable information about the effectiveness of meditation for stress reduction in college students. If the intervention is found to be effective, it may have important implications for promoting mental health among this population.
Advantages of Institutional Review Board
Here are some advantages of IRBs:
- Ethical Review: IRBs ensure that research studies are conducted in an ethical manner and that the rights and welfare of human subjects are protected. This includes ensuring that informed consent is obtained, risks are minimized, and benefits outweigh potential harms.
- Compliance: IRBs help ensure that researchers comply with relevant laws and regulations governing human subjects research, such as the Common Rule, HIPAA, and FDA regulations.
- Expertise: IRBs are typically composed of individuals with diverse expertise, including scientists, ethicists, and community members. This expertise allows IRBs to provide valuable feedback to researchers and ensure that research studies are well-designed and scientifically sound.
- Transparency: IRBs provide transparency in the research process by reviewing study protocols, monitoring ongoing research activities, and ensuring that study results are reported accurately.
- Trust: IRBs help build trust between researchers and the public by ensuring that research studies are conducted in a responsible and ethical manner. This can enhance the credibility and reputation of researchers and institutions conducting the research.
