The IRB Process

The risks to subject are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risks and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes 45 CFR 46.111(a).

It is necessary, therefore, that the IRB assess the validity of the study design in relation to the risks to human subjects. Research that is not scientifically valid exposes research subjects to risks of harm without any possibility of benefit. At BYU the validity of the study design can be accomplished in several ways as outlined in this guidance. 

Other factors that contribute to sound study design: evidence that key personnel are qualified by virtue of training and experience to conduct the research; a clear, well-written protocol that adheres to established principles of the discipline help to establish qualifications of the principal and co-investigators and ensures that the operational aspects of the research have been thought through. 

On the other hand, poorly written protocols that do not demonstrate principles of sound scientific design cannot be approved. Poorly written and designed protocols are the most common reasons for delay in IRB approval.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result...

The investigator should proceed by doing the following:

• Assessment of all of the risks associated with the research by identifying all potential harms that could befall a subject and the magnitude and the probability of those harms;
• Ensuring that the appropriate steps have been taken to minimize the risks that are identified; and
• Assessment of the possibility and importance of potential benefits to subjects (if any) and to science and society.

The research may be approved by the IRB provided that the benefits outweigh the risks to participants.

Factors that impact risk include:

• the procedure (possible harms);
• the person performing the procedure (training, experience, skill);
• the setting (privacy protections, availability of resuscitation equipment, etc.); and
• the characteristics of the research subject (age, health status).

It is the investigators obligation to explain what will be done, by whom and to whom and where it will be done. Protocols and applications that incompletely describe the study procedures frequently result in requests for more information.

The IRB takes into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. 

This criterion comes from the ethical principle of justice. No group is unduly burdened or will unfairly benefit from the research. Equitable selection does not mean that all groups are represented in proportion to the population. It means that the selection criteria should be both fair and appropriate to the research question. 

Researchers should be mindful of their study design and assess if it is feasible to include non-English speakers as subjects. The exclusion of non-English speakers must be scientifically supported and not used as a mere inconvenience to the researchers. In some cases, this exclusion is supported when surveys tests, questionnaires are not available in other languages. Some tests are not valid in any other language than English.

The protection of privacy applies to the human subjects in the study and confidentiality is the protection of their data. 

Privacy focuses on the environment where the study will take place, how researchers contact prospective subjects, and how research activities will be realized. Privacy issues depend on the study design and the target population. 

Confidentiality should consider the following: 

• How will access to data be managed? 
• Who should be permitted access to the study documents?
• Who should be allowed to know the identities of those participating as subjects?
• What security plan (password protections, locked cabinets, encryption methods, separate storage of Master Lists from study data) is sufficient to adequately protect the subjects given the inherent sensitivity of the data?

It is important to note that the degree of data security depends on the sensitivity of the data. However, it is good practice to limit identifiable data to research personnel that need to know only. It is also good practice to de-identify data as soon as possible. Investigators should consult with their area data security to create a plan that is up to date and appropriate for the sensitivity of data.

Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by federal regulations for the protection of human subjects.

Informed consent will be appropriately documented, in accordance with, and to the extent required by federal regulations for the protection of human subjects.

The consent process involves providing the information that a reasonable person would want to know in language that is understandable to the subject. Understandable means at a grade level that they can understand and in their native language.

The IRB has the authority to approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organizations. The IRB has the authority to suspend, place restrictions, or terminate approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IRB requirements or that have been associated with serious harm to subjects. The IRB has the authority to observe or have a third party observe the consent process and/or the research if the IRB determines it to be indicated.