Performing Ethical Research as a Plastic Surgeon in Private Practice: The Institutional Review Board

Plastic surgery as a specialty has embraced evidence-based medicine.1,2 With innovation at their core, plastic surgeons are striving to increase the levels of evidence in their specialty. This paradigm shift to evidence-based medicine has the potential to improve quality of care and patient safety in areas traditionally lacking evidence such as aesthetic surgery. Aesthetic surgery however is often performed in nontraditional settings for research such as private offices and ambulatory surgery centers independent of larger institutions. Many jurisdictions have medical professional society as well as healthcare government regulated oversight and regulations to safeguard patient safety and maintain standards of clinical care in such independent healthcare facilities. However, no readily identifiable systems to safeguard ethical conduct of research in these same facilities is generally present. Regardless of the location, all human research must be reviewed and approved by an Institutional Review Board (IRB) prior to study initiation. Unfortunately, private facilities typically do not have easy access to an IRB, making approval and oversight difficult to obtain. Obtaining an IRB for plastic surgeons in private practice is often a convoluted process and creates an obstacle in producing research and, in turn, improving the standards of care in aesthetic surgery. Several options exist for ethics board approval after determining whether the study requires it. This article will outline the function of an IRB, when one is required, and the IRB options that are available. In doing so, we hope to clarify some of the issues surrounding the IRB for plastic surgeons in private practice. An IRB, also known in Canada as a Research Ethics Board (REB), is a committee charged with approving, monitoring, and reviewing biomedical research involving human subjects.3 An IRB's goal is to protect the rights and welfare of research subjects. Researchers submit their study protocol and consent forms for an IRB to review. The main objectives of an IRB review are to assess the ethics of the research and its methods, ensure that the proposed informed consent process is appropriate and complete, and to maximize the safety of subjects once they are enrolled in the study. Finally, an IRB assesses that procedures for protecting confidentiality are adequate and that an appropriate system is in place to manage adverse events. Once this initial review is completed and approval is obtained the researcher is responsible for updating the IRB on any changes and providing regular updates on the study's progress. This means that IRB approval is not a one-time event, it is an ongoing process with the IRB being responsible for monitoring the research typically through annual reviews. IRBs are traditionally based in academic institutions to monitor internal research studies and avoid ethical problems. These modern ethical standards originated as a response to historical abuses of vulnerable populations during research.4 The Nuremberg Code was a response to atrocities committed in the name of medical research during the Second World War.5,6 Modern IRBs base their decisions on the Nuremberg Code's core principles, including capacity to consent, freedom from coercion, and comprehension of the study's risks and benefits. The Tuskegee Syphilis Study was an infamous study on African American males conducted by the US Public Health Service between 1932 and 1972 to examine the natural history of untreated syphilis.7,8 When news of this study became public, the resultant outrage led to the Belmont Report, the establishment of the Office of Human Research Protections (OHRP), and IRBs. The Belmont Report outlines three core ethical principles that the Tuskegee Syphilis Study violated: respect for persons, beneficence, and justice.9 Respect for persons recognizes the intrinsic values of human beings and the respect and consideration they are due. Beneficence refers to the concern that researchers must demonstrate for all aspects of participants' welfare. Justice refers to treating all people fairly and equitably. All of these ethical principles were codified into US law in 1991 in what is widely known as the Common Rule. This rule requires that all research involving human subjects be conducted under the oversight of the OHRP. Local IRBs must provide assurances that they are protecting the rights, safety, and welfare of human participants. Therefore, modern IRBs were established as a response to historical events to protect research participants from unethical research. IRB review and approval is required for all research involving human subjects. Furthermore, most scientific journals have adopted the principles of the Declaration of Helsinki (DOH) that requires the authors to state their project has been approved by an IRB in order to be published.10,11 The DOH is important because it is an internationally ratified document that is the ethical standard used by the International Committee of Medical Journal Editors and the Aesthetic Surgery Journal (ASJ) when considering research involving human subjects.10-13 In ASJ an article can be accepted provided that the author has followed the principles of the Belmont Report, the Department of Health & Human Services (DHHS) Regulations for the Protection of Human Subjects, or the DOH. The three main components of the DOH relevant to plastic surgery are10-13: The need for proper informed consent (Articles 25-31). The need for approval by a research ethics committee (Article 23). The need for research to be registered in a publicly accessible database before the patient is enrolled (Article 35). Two definitions are important here for our discussion: research and human subjects. “Research” is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. A study may not require IRB approval if it does not meet this definition. “Human subjects” (“participants”) are defined as those individuals whose data, or responses to interventions, stimuli, or questions by the researcher are relevant to answering the research question.3 Whether a project is research and whether it involves human subjects determines if IRB oversight will be required (Figure 1). Further decision charts that apply to all specific research scenarios can be found at the DHHS website.14 Another group called A Project Ethics Committee Consensus Initiative has also developed a web-based tool to help researchers decide whether they should seek IRB approval and will produce a letter documenting the outcome.15 These tools are helpful but when there is a question of whether or not a study is research or involves human subjects consulting with an IRB directly is advisable. It is important to note that some research is exempt from IRB review: information that is legally accessible to the public, where information is publicly accessible and there is no expectation of privacy (eg, information obtained via Google search). Ethics review decision algorithm. Although seldom applicable to the plastic surgeon performing aesthetic surgery, it is important to note that in both the United States and Canada, IRB approval is required to obtain any governmental funds for research. In the United States, research on human subjects is governed by two federal agencies: the DHHS and the Food and Drug Administration. The OHRP implements the regulations and assures that institutions comply with the Common Rule. Since it is federal law, it effectively makes research on human subjects without IRB approval illegal.16 In the United States, any retrospective study involving a drug or device must also be registered with clinicaltrials.gov, and there are fines for not registering. Furthermore, any retrospective study involving patients from an institution that receives federal funding must obtain IRB approval or a waiver to be certain that the patient data is anonymized per Health Insurance Portability and Accountability Act.16 In Canada funds are dispersed by Canada's three federal research agencies: the Canadian Institutes of Health Research, the Natural Science and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada, or collectively known as the Agencies.3 Once the requirement for an IRB review has been determined there are several options available (Table 1).14 Use an external, commercial IRB. Partner with an institution that has an IRB. Start an IRB for your private practice. Ethics Review Options Advantages and Disadvantages - Rapid review - Convenient - Many options - Expert, professional, and paid reviewers - Scalable up or down depending on amount of research - Expensive - No input on IRB composition - Reviews completed off site - Reviewers may be unfamiliar with type of research - Researcher's facility may still need federal-wide assurance* - Inexpensive - Relatively convenient - Facilitates local research collaboration - No input on IRB composition - Reviews completed off site - Slow review - Volunteer reviewers of variable experience - Researchers facility may still need federal-wide assurance* - Input on IRB formation structure and composition - Reviews completed on site - Speed of review under local control - Reviewer experience under local control - Reviewers and researchers familiar with each other and subject matter under investigation - Expensive - Time-consuming - Requires substantial institution/facility support - Not scalable, may only be needed for few studies per year - Requires federal-wide assurance and registration with OHRS* - Rapid review - Convenient - Many options - Expert, professional, and paid reviewers - Scalable up or down depending on amount of research - Expensive - No input on IRB composition - Reviews completed off site - Reviewers may be unfamiliar with type of research - Researcher's facility may still need federal-wide assurance* - Inexpensive - Relatively convenient - Facilitates local research collaboration - No input on IRB composition - Reviews completed off site - Slow review - Volunteer reviewers of variable experience - Researchers facility may still need federal-wide assurance* - Input on IRB formation structure and composition - Reviews completed on site - Speed of review under local control - Reviewer experience under local control - Reviewers and researchers familiar with each other and subject matter under investigation - Expensive - Time-consuming - Requires substantial institution/facility support - Not scalable, may only be needed for few studies per year - Requires federal-wide assurance and registration with OHRS* US-specific criteria. Ethics Review Options Advantages and Disadvantages - Rapid review - Convenient - Many options - Expert, professional, and paid reviewers - Scalable up or down depending on amount of research - Expensive - No input on IRB composition - Reviews completed off site - Reviewers may be unfamiliar with type of research - Researcher's facility may still need federal-wide assurance* - Inexpensive - Relatively convenient - Facilitates local research collaboration - No input on IRB composition - Reviews completed off site - Slow review - Volunteer reviewers of variable experience - Researchers facility may still need federal-wide assurance* - Input on IRB formation structure and composition - Reviews completed on site - Speed of review under local control - Reviewer experience under local control - Reviewers and researchers familiar with each other and subject matter under investigation - Expensive - Time-consuming - Requires substantial institution/facility support - Not scalable, may only be needed for few studies per year - Requires federal-wide assurance and registration with OHRS* - Rapid review - Convenient - Many options - Expert, professional, and paid reviewers - Scalable up or down depending on amount of research - Expensive - No input on IRB composition - Reviews completed off site - Reviewers may be unfamiliar with type of research - Researcher's facility may still need federal-wide assurance* - Inexpensive - Relatively convenient - Facilitates local research collaboration - No input on IRB composition - Reviews completed off site - Slow review - Volunteer reviewers of variable experience - Researchers facility may still need federal-wide assurance* - Input on IRB formation structure and composition - Reviews completed on site - Speed of review under local control - Reviewer experience under local control - Reviewers and researchers familiar with each other and subject matter under investigation - Expensive - Time-consuming - Requires substantial institution/facility support - Not scalable, may only be needed for few studies per year - Requires federal-wide assurance and registration with OHRS* US-specific criteria. A commercial IRB has already completed the registration and accreditation process within their respective jurisdiction and has the authority to oversee and approve research involving human subjects. A list of commercial IRBs in both the United States and Canada can be found online.17 These companies are for profit and will charge the investigator for the review. The fees vary depending on the size and type of study but can range into the tens of thousands of dollars. There are advantages to using a commercial IRB, such as having a large number to choose from. They are also often customer friendly, easy to work with, and will provide a rapid review result. Commercial IRBs tend to meet daily and are staffed by paid professionals as opposed to hospital IRBs that are made up of volunteers who meet infrequently. The disadvantages of commercial boards are that they can be expensive, may be unfamiliar with the type of research, and there can be ethical problems with paying for review.18-20 Partnering with a local IRB is another means available to the plastic surgeon in private practice. Plastic surgeons may have access to an IRB through their hospital privileges and/or university affiliations. The chosen institution agrees to be the IRB of record for the study and usually requires a formal agreement or memorandum of understanding. This memorandum will outline what role of oversight the IRB will assume and is determined after review of the study protocol, consent documents, and any other study related literature. Furthermore, the agreement will clarify ultimate responsibility for the ethical acceptability of the research undertaken. The IRB in this case is giving an opinion on the ethical soundness of the research being performed and relies on the individual researcher to adhere to its suggestions. To demonstrate accountability, institutions often issue public reports summarizing their activities, IRB membership, and relevant research ethics education and training. The advantage of partnering with a nearby institution is the potential cost and time savings when compared with establishing your own IRB. Other advantages include sharing of local customs and standards of care and fostering future research collaborations within that institution. The disadvantages of a local partner is that it may be difficult to come to a formal agreement that satisfies both parties, the financial arrangement may be costly and the time required for review, and approval may be excessively long.20,21 These IRB committee members are often unpaid volunteers being asked to perform tedious and time consuming activities. This fact is often reflected in the quality and timeliness of the reviews. The final option available to the plastic surgeon in private practice is to establish an IRB. This process differs slightly in the United States and Canada but the basic requirements are the same. In Canada, the agencies lay out the specific requirements in the Tri-Council Policy Statement (TCPS) on ethical conduct for research involving humans.3 In the United States, the IRB must comply with federally mandated requirements and register with the DHHS. Registering of an IRB with the DHHS is currently mandatory for US IRBS and optional for non-US IRBs.13 An IRB is further mandated to record IRB activities including: research protocols reviewed, minutes of meetings, copies of all correspondence between investigators and reviewers, and all records must be kept for 3 years. Furthermore in the United States, the IRB must provide assurances to the federal government that it will follow ethical rules and regulations and submit to oversight by the DHHS.22 There are also nonprofit organizations such as the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) that will inspect and accredit an IRB to determine if it fulfills all the ethical research principles mandated by the TCPS and DHHS. IRBs receive their mandate for research overview from their respective institution be it a hospital, university, or in the private practice from the highest member within the organization. This person, once designated, is then responsible for defining an appropriate reporting relationship, ensuring that the IRB has sufficient administrative and financial resources to fulfill its duties. An IRB must be independent in its decision making and once established, any plastic surgeon at the institution or private practice must not override the decisions and recommendations of the IRB. Therefore, a plastic surgeon involved in the research at the institution or private practice could not sit on the IRB but could fund it as long as the IRB members and review decisions are independent and there are no members with conflicts of interest. This is analogous to larger research institutions such as hospitals or universities with their own IRBs to review their own research. The benefits of starting an IRB include having a say in how the IRB is organized and administrated. This could be advantageous, especially in having board membership made up of individuals in the of aesthetic plastic surgery and its ethical a board with this could also the review as will be familiar with the researchers and type of research being volunteers could also in as this is their of interest. The include the time and to and support IRB members who will fulfill all the IRB In there may be to fund the administrative IRB meetings, and the of the IRB. An IRB requires at including both and The specific board member experience differs between Canada and the United States (Table a Canadian the requirements are at two in the reviewed, one with ethics one with and one In the United States, the IRB committee requirements are one one and one member who are not with the IRB's institution. The number of members can be to is needed to the and to to any involved with an in the research. an aesthetic surgery IRB an independent plastic surgeon and a familiar with aesthetic surgery on its can also in one The member process and of should be and and the institution requires a in support of this The IRB must provide and ensure that the IRB is in with its own and ethical In the TCPS document requires that not be involved in the IRB in order to ensure independent IRB members with a of are required to from in a review with they a In the United States, a list of IRB relevant and with the institution must be to the OHRP. Institutional Review Board (IRB) and Research Ethics Board Institutional Review Board (IRB) and Research Ethics Board The IRB must meet for of research Furthermore, IRB require a member to be and require in place to ensure a In the United States, there are three of and In Canada, there are and reviews. The of to participants is the determining for the of IRB review. IRB decision making must be an independent process and the board should provide in to the researchers under review. In order to approval a study must risks to participants. must be in to the consent must be reviewed in to ensure that subjects the of the research and are to choose not to IRB approval is not an but a process that involves oversight to the of to participants in the study. The IRB is responsible for records related to the it and the decisions it The is for and to an process for The DOH has several to the function of an IRB and of research The principles of the DOH most relevant to plastic surgery have been When the IRB studies on research involving human each study must be registered in a publicly available database before of the When are both and must be made publicly available if not When all of funding and conflicts of must be to be in with the DOH. also have a responsibility here to not in with The IRB option that a plastic surgeon on several An important is how research ethics oversight will the plastic surgeon be It may to a commercial IRB if only a few research are the number of studies the for approval and oversight may it to partner with another IRB or to your The time and cost of and an IRB within a private practice may not be the sufficient research is being performed that it cost paying an a plastic surgeon may choose to out ethics monitoring for the involved the when considering establishing an independent IRB it may be difficult to board members who are have no conflicts of will fulfill regular and perform all of these in a cost This is in larger institutions that have a of and individuals to from and a number of studies the IRBs are not without their have as that time and resources without into of human research subjects. The and time involved are well there is evidence that they are IRB review can often an of especially if the IRB is at institutions. have out that this in may be Other on the IRB's mandate to ongoing research and to monitor for adverse are also Furthermore, an IRB is only as as its In the of proper in or in the of conflicts of an IRB's function will be These are well and can be by our being of and to avoid these as as IRB options exist for plastic surgeons in private practice to conduct research activities. IRB review is mandatory for government research. journals have IRB review or with the DOH for with an IRB, the proper reporting of adverse and study monitoring are the of an ethical The ultimate responsibility for ensuring patient safety with the Plastic surgeons in private practice can conduct research that is ethical by both the ethical principles in this article and an IRB. This research will our specialty and to for our the ultimate goal for all plastic The authors no potential conflicts of with respect to the research, and of this The authors no financial support for the research, and of this

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