Which of the Following Studies Would Need IRB Approval?
As of 2007, the regulations for IRB approval of studies have been changed to require that all studies involving people or animals first be reviewed by an institutional review board (IRB) before they can commence. A list of common research types and what IRBs must approve follows. If the research does not fall into one of these categories, then IRB approval is not required.
Informed consent is required for all studies involving human subjects. This includes surveys, focus groups, interviews, naturalistic observations, program evaluations, and behavioral interventions. All research reports must be submitted to the IRB promptly. Information regarding proposals submitted to the IRB is confidential and protected by federal law (42 USC § 299c-3(c)). The rights and safety of subjects will always be paramount during data collection or when conducting any human subjects research study that requires IRB review.
The IRB is a board of experts that oversees research projects and reviews all applications for ethical consideration. There are two main types of research – qualitative and quantitative. Qualitative research involves the humanities, whereas quantitative research typically involves hard sciences. In addition, qualitative studies use open-ended methodology, while quantitative studies often use statistical techniques.
Research That Offers Therapeutic Benefit
An IRB evaluates a research project’s potential benefits and risks to decide whether to grant it approval. These benefits could be to the study subject or the community. The benefits of the research should be spelled out in the protocol. The IRB can approve the study, but not a therapy that is not in the best interest of the research subject.
An IRB reviewer may waive the requirement for research subjects to sign the Authorization Form if the research involves minimal risk to the participants’ privacy. For this to be granted, the researcher must explain to the IRB that obtaining signed authorizations would pose an undue burden on the subjects. The researcher should also indicate that obtaining a signed consent from participants would be impractical.
IRB approval is essential for research that involves patients. In addition to ethical considerations, regulatory requirements must be met. For example, an IRB review would be necessary to protect the participants if the research involves a drug not licensed by the FDA.
The IRB will assign a committee to review the application. An IRB reviewer will review the application and any documents uploaded during the review process. If the application is incomplete, it will be returned to the researcher. In addition, the Consent Form Specialist will also review the consent form and make any necessary changes. If additional changes are needed, the IRB committee will request them.
In addition, the IRB reviews the experimental design and procedures that are consistent with sound research design. For example, some studies require deception and withholding information, but these deceptions must be justified with a detailed rationale and must not affect the research subject’s progress or situation.
Research that does not Contain Personal Identifiers
In most cases, research that does not include personal identifiers, like names and addresses of living relatives, would not require IRB approval. However, certain types of research, including genetic studies that include personal information, would still require approval. In such cases, a PI could request a waiver. However, this request would need to be detailed and include several components. If a waiver request is incomplete, the IRB may deny the application.
For example, research that collects leftover biological materials, such as blood from patients who have already undergone a diagnostic procedure, may need IRB review, even if the data are anonymous. This is because such research can put subjects at risk, including if researchers ask questions about their employers, such as whether they engage in illegal behavior. Similarly, research that uses psychologically invasive testing may need IRB approval, as it could result in psychological or emotional distress.
Sometimes, a researcher can obtain anonymized data by stripping them of personal identifiers. The anonymized data may then be stored and maintained. For example, a researcher could transcribe video recordings, code them, and destroy the originals but keep the de-identified transcript. This same process would be followed if a researcher had received identifiable data through a data-sharing agreement.
When research consists of de-identified data that has been coded, it is considered non-human subjects research. This type of research is not FDA-regulated. A PI would certify the non-human research status of the research.
When conducting qualitative research, it is essential to note that IRB regulations do not expressly exclude qualitative methods. There are specific sections of the IRB guidelines that explicitly include such methods, such as interviews and surveys. The subpage of the IRB website that deals specifically with qualitative methods includes information about essential differences between qualitative and quantitative research, as well as suggestions for qualitative researchers when dealing with the IRB.
First, knowing what type of IRB approval you will need for your study is essential. This will depend on the type of project you plan to conduct. If the project poses minimal risks, you can apply for an expedited review, which typically takes only a few days. However, if your research has a higher risk, you must apply for a full board review. This process is more time-consuming and will require an additional budget.
In addition to obtaining IRB approval for your research, you should ensure that the project will meet all regulations and guidelines. For example, IRB approval is required for research involving deceased individuals or genetic studies that use people’s private information. To ensure compliance with regulations, you should also ensure that the IRB has reviewed all the materials you plan to collect.
Once you’ve secured IRB approval, you can start collecting and analyzing data. Then, submit your study protocol to the IRB for review. You can find sample IRB applications online. It’s also a good idea to take a free online course on qualitative data analysis. It can help you streamline your codes and make your data easier to analyze.
Quality Assurance Activities
Quality assurance activities (QI) are integral to an organization’s operations. They typically involve data-driven processes and human participants. As such, they may overlap with research methodologies. Therefore, it is essential to obtain IRB approval before conducting any QI/QA activities.
Whether or not a quality assurance activity requires IRB approval depends on its purpose and nature. Generally, quality assurance activities will require IRB approval if they are based on human subjects and contribute to the generalizability of knowledge. However, if a quality assurance activity is intended for an internal evaluation of a particular program, it would not need IRB approval.
A quality assurance team must be informed of IRB rules and regulations. It should be able to provide constructive feedback on study procedures and educate investigators about IRB requirements. In addition, the team should be able to select a wide range of studies for review. This ensures that investigators are better prepared for external audits.
Quality assurance activities are systematic and data-guided activities. They aim to improve the quality of care and patient safety by identifying areas for improvement. They also include research activities that improve the performance of existing services or develop new ones. Some QI activities would not qualify as research, however.
To prevent ethical violations, project leaders should review interventions that may introduce risk. For example, a behavioral modification system in a clinical study can pose ethical issues. Proper consent must be obtained from the patients, and confidentiality must be maintained. Therefore, the project leader should review the behavioral modification system before implementing it in clinical trials. By incorporating these safeguards into the study, the project will be more likely to avoid ethical pitfalls.
An evaluation project will need IRB approval if it involves human subjects. However, it is essential to note that not all evaluation projects require IRB approval. For example, evaluation projects are generally not considered research, so they do not require IRB review. To determine whether your evaluation project would require IRB review, you must first answer the Step 2 question.
Typically, evaluation projects would require IRB approval if they involved human subjects or cadavers. This is because the research is intended to educate individual students and uncover general principles or phenomena. In such cases, the project results would only be shared with the course instructor and faculty advisor and may not be used for generalizability.
A researcher will also need IRB approval to research living people, such as genetic studies. The IRB defines genetic studies as human subjects research because they involve collecting private identifiable information from third parties. The University of New Hampshire’s psychology department uses a Departmental Review Committee to review minimal-risk research projects. These projects also contain data used for departmental or university administrative purposes.
Using an evaluation tool for academic assessment projects can help researchers determine whether they are conducting research. The Common Rule Tool helps study teams determine if a project is an evaluation, quality improvement, or research study. In addition, the tool can help researchers determine whether they need to seek IRB approval for their projects.
In addition to determining whether an evaluation project would need IRB approval, instructors should also check if their research involves minors. Minors must have consent before participating in research conducted on them.