Institutional Review Board Approval of Plastic Surgery Studies: Why It Matters

Institutional review board (IRB) approval is a well-established requirement for studies involving human subjects.1,2 Ethical standards for human subjects research, shaped by the Nuremberg Code and the infamous Tuskegee Syphilis Study, led to the creation of IRBs and federal oversight.1,2 These standards were codified into U.S. law in 1991 as the Common Rule. It is unlawful to conduct a research study involving human subjects without such approval.1–3 Prerequisites for publication include IRB approval, disclosure of financial conflicts, and disclosure of the regulatory status of devices.3 The IRB developed out of recognition that physicians, who naturally champion their methods and devices, may not be aware of their potential for harm or lack of clinical benefit. Surprisingly, this requirement is frequently overlooked.3 Authors may believe that a retrospective study is exempt. They may (incorrectly)1–3 believe that because they are in private practice, they lack access to an IRB and therefore may be excused from this prerequisite. Authors frequently report that they follow the guidelines of the Declaration of Helsinki,3 evidently unaware that the Declaration of Helsinki includes a requirement for review by an independent ethics committee before the study is initiated.4 This declaration incorporates ethical review; it is not a substitute. The principles of the Declaration of Helsinki most relevant to plastic surgery include the need for proper informed consent before enrollment, the need for approval by an independent ethical review board, the need to disclose negative as well as positive results, and the need for proper disclosure of all sources of funding, institutional affiliations, and conflicts of interest.2 Authors need to know whether they require IRB approval and when this approval needs to be obtained. Plastic surgeons in private practice should understand how they can access an IRB. Reviewers and editors must be knowledgeable regarding the prerequisites for acceptance of a manuscript.3 The lack of adherence to this standard is evidenced by numerous studies published without IRB approval across a range of interventions. CHEMOPROPHYLAXIS A 2022 publication on venous thromboembolism prevention,5 coauthored by 2 surgeons at Stanford University, included an ethical approval statement indicating that the lead author, who is in private practice, does “not have access to a formal institutional review board process. Thus, our Methods statement confirms that the principles outlined in the Declaration of Helsinki were followed.” Morales et al,6 in a study of oral anticoagulants for venous thromboembolism (VTE) prophylaxis reported that IRB approval “was not obtained for this study as it was completed at a private practice, but the study complied with the Declaration of Helsinki guidelines and informed consent was obtained from all patients.” Vasilakis et al,7 in their study of rivaroxaban for this purpose, explained that IRB approval was not sought because the study was a retrospective chart review of previously established postoperative protocols, but it conformed to the World Medical Association Declaration of Helsinki. A recent systematic review of VTE prevention protocols found that 12 of the 24 retrospective studies (50%) did not report either IRB approval or exemption.8 RADIOFREQUENCY Publications on subsurface radiofrequency treatments often do not report IRB approval.9–15 A systematic review of publications evaluating helium plasma radiofrequency treatments found that 11 studies (44%) did not report IRB approval.15 BREAST SURGERY In a 2025 study published in Aesthetic Surgery Journal,16 the authors reported their experience performing secondary augmentation mastopexies, including 97 cases in which poly-4-hydroxybutyrate mesh (GalaFLEX, BD, Franklin Lakes, NJ) was inserted and 21 women treated with Strattice, a porcine acellular dermal matrix (ADM) manufactured by AbbVie Company (North Chicago, IL). The authors explained that they worked in a private practice office setting that did not have an IRB, and that the study was conducted in accordance with the Declaration of Helsinki. Mallucci and Bistoni17 did not mention IRB approval, but reported that full informed consent was obtained for all patients undergoing implantation of a GalaFLEX scaffold according to the Helsinki principle. Buccheri et al,18 in their review of constricted breasts treated with textured anatomic implants, reported that because their study was retrospective, IRB approval was unnecessary.Venkataram et al19 believed that their study of antimicrobial implant pocket irrigation was IRB exempt. The authors of both publications18,19 reported that their studies were conducted following the guiding principles of the Declaration of Helsinki. Johnstone et al20 published their experience inserting antibiotic-impregnated polymethylmethacrylate plates during breast reconstruction with no mention of IRB approval. A later publication reported that the data were retrospectively collected after independent IRB approval.21 In a study supporting the Keller funnel,22 the authors reported (incorrectly) that IRB review was not available, “but all study practices followed the guidelines of the Department of Health and Human Services Regulations for the Protection of Human Subjects.” ACELLULAR DERMAL MATRIX TO TREAT CAPSULAR CONTRACTURES Studies of patients treated with ADM to manage or prevent capsular contracture frequently lack IRB approval.23–27 A widely viewed study serves as a case in point. In a 2020 publication,27 reporting their first 32 patients treated with ADM and a treatment algorithm, Hidalgo and Weinstein did not mention whether their study had IRB approval. Aaron Weinstein, the coauthor, presented this clinical research study at the 2024 Spring Meeting of the American Society of Plastic Surgeons (ASPS).28 Weinstein explained that the study was retrospective and observational, and the authors believed that it was exempt from IRB approval. Surprisingly, a year later, at the 2025 ASPS Spring meeting, Weinstein reported that IRB approval had been obtained for the study.29 TIMING OF IRB APPROVAL In their 2025 publication,30 the authors report that their retrospective cohort study of 100 consecutive patients “was conducted following Weill Cornell IRB approval.” The timing of an IRB approval is important. According to Weill Cornell Medicine, “Projects that meet the definition of human subjects research require submission to the IRB. We do not recommend that investigators make their own determination of whether or not their activities are exempt from IRB review and oversight, or if their study should receive a not human subjects research (NHSR) determination. If an investigator fails to obtain a research determination before implementing activities and those activities require IRB review and oversight, they are liable for noncompliance! [exclamation point from Weill Cornell IRB].”31 Insistence on IRB approval before a human subject research study is undertaken is not just an institutional requirement. The Department of Health and Human Services (Title 45, Code of Federal Regulations Part 46) and the US Food and Drug Administration (FDA) Regulations (Title 21, CFR 56) require IRB approval before any research interventions or interactions with human subjects take place. Regulation 45 CFR 46.103 emphasizes, “Under no condition shall research covered by this section be initiated before receipt of the certification that the research has been reviewed and approved by the IRB.”32 According to the FDA, any clinical investigation “shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part.”33 This prerequisite is recognized internationally. The World Medical Association Declaration of Helsinki explicitly requires that researchers obtain independent ethics committee approval before a human-subjects study begins.4 Failure to obtain IRB approval violates federal regulations and can result in a report of noncompliance to university officials, if applicable, as well as the Office of Human Research Protections in Washington DC.2 FDA REGULATIONS Three questions determine whether a study is governed by FDA regulations.31 The first question is whether the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Although not normally considered a disease, a capsular contracture is an abnormal condition that the authors seek to mitigate, treat, and prevent. The second question is whether the researchers are conducting a clinical investigation, which is “any experiment that involves a test article [a drug, biological, or device] and one or more human subjects.” The third question is whether human subjects participate in the research. If the answer to the 3 questions is “yes,” then the research is FDA-regulated. “RETROSPECTIVE IRB APPROVAL” Evidently, after initially believing they did not need one,28 Hidalgo and Weinstein30 applied for IRB approval in 2024, after completion of the 10-year study period (2014 to 2024) and treatment of 100 patients. Approving such an application appears to contradict the strong language of the Weill Cornell IRB.31 How meaningful is an approval that is obtained after the study period? The FDA states unequivocably that a “post hoc review by an IRB is contrary to the purposes of IRB review.”34 Obtaining IRB approval after the study has been completed defeats the purpose. Patients have already been exposed to the intervention when the study is over. Part of the function of an IRB is patient protection, including additional informed consent (not just the usual surgical consent forms) regarding the purpose and nature of the study, possible risks and benefits, and the patient’s right to refuse to participate or withdraw from the study without prejudicing her medical care. Allowing retrospective approval would undermine the purpose of the IRB to protect human subjects by creating a loophole for unreviewed research.34 Consequently, an IRB may not “rubber stamp” activities that have already happened.34 Although it cannot grant retroactive approval, the IRB may determine the activity was unapproved human subject research, document noncompliance, require corrective actions, and review whether the data may ethically or legally be used for publication. Some institutions prohibit the publication of nonapproved human research. Many journals require documentation of IRB review. The Journal of Plastic and Reconstructive Surgery insists that “any systematic data gathered from patients or volunteers must be approved by an IRB or adhere to local/national regulations.”35 This approval should be included in the Methods section of the manuscript. This requirement was evidently overlooked for the authors’ 2020 publication.27 DEFINITION OF “RESEARCH” Research studies in humans are always subject to IRB approval.4,31–36 Common rule (45 CFR 46.102(h)) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”32,36 Examples of research include (1) creating a protocol, (2) defining eligibility criteria, (3) collecting standardized outcome measures (eg, a Grade III/IV capsular contracture), (4) recording data for later analysis, and (5) prospective or retrospective hypothesis testing. If data are collected for analysis, the activity almost always counts as research.36 In the case of inserting Strattice for capsular contracture treatment, the fact that Weill Cornell Medicine subsequently approved an IRB application29,30 confirms that this activity was indeed research. Otherwise, the work would not require IRB approval. EXEMPTIONS Exemptions are limited to educational techniques, observations of public behavior, behavioral interventions, secondary research of existing data or specimens, research and demonstration projects supported by a federal agency, and taste research.36 ACCESS TO AN IRB FOR THE INVESTIGATOR IN PRIVATE PRACTICE Surgeons in private practice are not at a disadvantage.1–3 Accredited IRBs are available outside of academic institutions. I have used one for years–Advarra (Columbia, MD), which is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).37 Another major independent IRB is WCG IRB (formerly Western IRB).38 A list of all 249 accredited organizations providing this service is available on the AAHRPP website.39 Although there is a fee, it is not onerous, less than the fee for Open Access publication of an original article. Turnaround times are quick, often just a week or 2. A consent form is formulated for patients. This document is not the usual surgery consent form explaining the risks of surgery, but one made specifically for the purposes of the study. The patient’s rights are explained, including the right to refuse participation. Patient confidentiality is protected. The form includes a provision for reporting concerns or adverse events.1 PROSPECTIVE STUDIES A benefit of obtaining IRB approval before the study is that the investigation is now a prospective one. The study design is more carefully considered. Eligibility criteria can be put into place. Such studies have a higher level of evidence.40 There is less opportunity for confirmation bias because the investigators do not already “know” the outcome of the study. A frequent problem encountered in retrospective studies is that the authors have, in many cases, already replaced their old method with a new one. There is a natural inclination to find superiority of the newer method. For example, it may be difficult to justify the additional expense of ADM incurred by patients after learning that the outcomes are not significantly improved by the insertion of this foreign biological material.41 With regard to radiofrequency treatments, it may be difficult to justify extra fees paid by patients (and the cost of the device) for technology that is intended to provide more skin tightening, but may fall short of this goal.14,15 POTENTIAL FOR HARM Most of the interventions, products, and devices pioneered by plastic surgeons carry risks of adverse outcomes. In many cases (eg, chemoprophylaxis, radiofrequency, helium plasma, Keller funnel, mesh, antimicrobial pocket irrigation, antibiotic plates, and ADM), the benefit has not been clearly established. These risks are not always trivial ones, such as excessive bleeding from routine anticoagulation,8 skin burns, and subcutaneous emphysema.14,15 Patients may incur avoidable financial hardship.41 Many widely adopted methods (eg, chemoprophylaxis)8 and products (eg, ADM)41 are not FDA-approved for the intended plastic surgery application. CONCLUSIONS The regulatory provision for IRB approval is not just a matter of red tape. Medical history is rife with examples of serious ethical violations in medicine, which led to the creation of the IRB in the first place.1–3 Insistence on IRB approval can only enhance the quality of plastic surgery publications and improve the level of safety for our patients.