Q: Inquiries about IRB

Detailed Question -

1. Most journals require to mention IRB for human studies. On what basis do they require this?
2. Should manuscripts, not case reports, such as simple images in clinical medicine (Image vignette, etc.) also mention IRB?

1 Answer to this question

An Institutional Review Board (IRB) is a committee that reviews and approves research involving human subjects. “IRB” is the generic term used in the United States, but the board/committee may be called differently in different countries and institutions, e.g., research ethics committee (REC) in the United Kingdom or research ethics board (REB) in Canada. The purpose of an IRB is to ensure that all human research be conducted in accordance with legal, institutional, and professional ethical guidelines.

An IRB serves to protect the rights and welfare of human research subjects. As you rightly observed, most journals require IRB approvals or waivers for human studies. To answer your first question, this depends on the nature of the study. Broadly, the review categories are as follows:

i. IRB review not required: If the research application is determined to not meet the requirement of human subject research, it does not need to be reviewed by the IRB.

ii. Exempt review: An “exempt” IRB review is selected when the research falls into one of the approved categories of exempt research according to certain defined regulations. Exempt does not mean the study is exempt from IRB review. The categories represent studies that present minimal risk to subjects, e.g., anonymous surveys, research that does not involve invasive/sensitive questions.

iii. Expedited review: If the research does not meet the exempt review criteria but involves no more than minimal risk, it is classified as expedited.

iv. Full review: Research that does not meet the criteria of the previous review categories (typically involves more than minimal risk) is classified as a full review.

Other categories are “Amendments or Modification Review” and “Continuing review.”

To answer your second question, simple clinical images, image vignettes, etc., might involve the use of images recorded and presented by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Such submissions may fall under the category of “IRB review not required” or “exempt review.” Nonetheless, you may need to approach the IRB or local ethics review committee, who will decide the category and provide the necessary approval or waiver. If, for some reason, approval is not available because your institution or country does not require approval for such studies, be sure to clarify that informed consent from the patient(s) is available and there are no ethics issues in the study.