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The definition of scientific merit is open to interpretation based on both philosophical perspective and research tradition. While different organizations and IRBs may have slightly different processes for determining the scientific merit of a study, there are some common elements you should consider.

Who cares about scientific merit? This brief article explains why the research community should care about scientific merit.

Why is scientific merit important?

Research ethics and scientific merit are closely related. Ethical research begins with the conceptualization of the study and ends when the results and findings of the study are disseminated. Scientific merit refers to the sound design of the study. Broken down to the most simplistic concept, can the proposed study answer the research questions?

Institutional Review Boards (IRBs) may also review the merit of the study to comply with federal research regulations and to make decisions that support the ethical principles in accepted ethical codes such as the Nuremberg Code and the Declaration of Helsinki. Researchers and IRBs must carefully consider the study design and overall scientific quality of each study. Below are three key areas to consider:

1. According to OHRP the IRB must consider scientific merit when evaluating the risk and benefits of studies. According to the regulations, the final authority on whether or not the study design or methodology demonstrates sufficient merit to justify the risk rests with the IRB. In other words, the final review for scientific merit is part of the IRB review.

2. Studies must be able to answer the research questions. If the purpose of the study is to answer certain questions and the study, because of its design, will not be able to answer those questions, then we know the study cannot achieve its purpose.

3. This does not mean each study is perfect. If the study can answer the research questions, the purpose is accurate, and there is minimal risk, we can make suggestions on improvements but can’t require them as a condition of approval.

The following questions can assist researchers design a study with scientific merit.

Are the procedures are consistent with sound research design?

Is the study design appropriate given the hypothesis being tested? appropriateness of the study design given the hypothesis being tested?

Is the study is designed in a manner likely to answer the research questions?

Are the research questions aligned with the proposed data collection and analysis?

Does the study have the potential to contribute to the field or add to the existing body of knowledge?

Will the knowledge to be gained sufficiently important to justify the risks involved?

Are the risks are minimized and benefits are optimized to the extent possible?

Does the proposed sample contain number of participants is large enough to result in reliable, replicable results without exposing excessive numbers of participants to the risk of the research?

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The team at Solutions IRB can answer your IRB and human subject protections questions.