The Current IRB Governing System Constrains Community-Based Participatory Research

The Current IRB Governing System Constrains Community-Based Participatory ResearchYana Puckett, MD

What is an IRB?An IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

What is CBPR?Community Based Participatory Research is a collaborative that equitably involves all partners in the research process and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community and has the aim of combining knowledge with action and achieving social change to improve health outcomes and eliminate health disparities.

The TensionIRB Guidelines are too restrictive?

Protecting Communities versus Individuals?

Differing frameworks- how well will these partners dance IRB and CBPR

The conduct of institutional review boards in ensuring ethical protocol is followed has been debated and evaluated for a number of years. The IRB decision-making process utilizes a number of regulations in order to protect human subjects in research purposes. Many critics of the system argue that the strict guidelines make it increasingly difficult to retrieve beneficial results and conduct the experiment as initially planned. However, others believe that the standardization involved with the IRB processes makes research practice safer, more transparent, and more effective. Our paper will critique the ethical component of IRB research and its effects on inhibiting or promoting public health practice. In particular, we will address the following question: How do existing IRB guidelines constrain community-based participatory research?

The IRBCreated in the 70s to standardize a process to keep human subjects safeAn IRB must have at least five membersChairpersonScientific memberNonscientific memberLay person not affiliated with the institutionPractitioner Board looks at risk/benefit for individual and society

-Created after a wave of unethical research in the US -board must be qualified through experience, diversity of their backgrounds (cultural, gender, racial, local, sensitivity to community needs)

Who does the IRB Protect?Participantssafety and confidentialityEthically, the IRB looks at respect for the person, beneficence, and Justice (Wagner) ResearchersResearch InstitutionsSafety from bad press and regulatory action

Confidentiality: following HIPAA when databases or registries are involvedRespect for the person: individuals are allowed to choose if they would like to participate or notBeneficence: harm should be minimized and the benefit maximizedJustice: Risks and benefits should be spread fairly among potential individual subjects and populationsALSO protects institution from potential lawsuits

Flexibility of the IRBResearch with minimal harm could be exempt from the IRBLess paperworkThe entire board does not need to review the studyVerbal and possibly no consent Some IRBs do not exempt

exempt: low risk survey or observational research, but most institutions require IRB review for any study that is involving interactions with subjects.

Adverse EventsA serious adverse experience is any experience that suggests a significant hazard, contraindication, side effect, or precaution. With respect to human clinical experience, a serious adverse drug experience includes any experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose (Prentice & Gordon, 2)Cost effective continuous monitoring system

$ effective: not everything has to be reported, but it is the IRBs responsibility to contact the department or agency heads if there is an issue like described above (NOT all need to be reported because that would make the system much more inefficient)

(Oakes, 469)

Arguments Against Current IRB SystemEthics culture of IRB protects itself at expense of community empowerment.

IRB may encourage deceit.

Tension between researchers and IRB.

Current IRB system operates within biomedical framework.

IRB IssuesCommunication between board members, researchers, and existing policies

Effectiveness of existing boards in navigating different types of research

https://intentionalmuseum.files.wordpress.com/2014/03/1609_color_nit-picking_irb.jpg

Alternative IRB ConstructionsCanadian IRBsCanadian IRBs do a better job of comprehensively evaluating CPBR methods and protocol necessary in order to successfully execute these studies. Interviewees agree that effective communication and understanding from IRBs on how CPBRs operate is critical to their success.Johns Hopkins CBPR Johns Hopkins University strives to better evaluate and integrate CPBR practices into the IRB. The study recognizes that IRBs are not suited for handling community-based interventions and a change in IRB operation will be critical in engaging this shift. It makes recommendations for training individuals to be more culturally competent and comfortable in working with the community while adhering to IRB guidelines. It also advises more understanding and training for IRB board members in the CPBR process.

Conclusions/Recommendations3 Recommendations:More effective training in CBPREach IRB should have one member fluent in CBPRImprove communicationOverall Goal: Develop healthier, transparent relationships to benefit both parties and improve CBPR understanding and regulation. Yay public health ethics!

Questions?

ReferencesLondon, Leslie. "Ethical oversight of public health research: can rules and IRBs make a difference in developing countries?." American Journal of Public Health 92.7 (2002): 1079-1084.Ruof, Mary C. "Vulnerability, vulnerable populations, and policy." Kennedy Institute of Ethics Journal 14.4 (2004): 411-425.Burris, Scott, and Kathryn Moss. "US health researchers review their ethics review boards: A qualitative study." Journal of Empirical Research on Human Research Ethics 1.2 (2006): 39-58.Abbott, Lura, and Christine Grady. "A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn."Journal of Empirical Research on Human Research Ethics 6.1 (2011): 3-19.Wallerstein, Nina B., and Bonnie Duran. "Using community-based participatory research to address health disparities." Health promotion practice 7.3 (2006): 312-323.Enfield, Kyle, and Jonathon Truwit. "The Purpose, Composition, and Function of an Institutional Review Board: Balancing Priorities." Respiratory Care 53.10 (2008): 1330-336. Respiratory Care. Web. 20 Oct. 2015. Wagner, Richard. "Ethical Review of Research Involving Human Subjects: When and Why Is IRB Review Necessary?" Muscle & Nerve 28.1 (2003): 27-39. Muscle & Nerve. Web. 20 Oct. 2015. Oakes, J. "Risks and Wrongs in Social Science Research." SAGE Journals 26.5 (2002): 443-79. Evaluation Review. Web. 20 Oct. 2015. Prentice, Ernest, and Bruce Gordon. "IRB Review of Adverse Events in Investigational Drug Studies." 19.6 (1997): 1-4. Jstor. Hastings Center. Web. 20 Oct. 2015. Hill, Jennie L et al. Does Availability of Physical Activity and Food Outlets Differ by Race and Income? Findings from an Enumeration Study in a Health Disparate Region. The International Journal of Behavioral Nutrition and Physical Activity 9 (2012): 105. PMC. Web. 9 Nov. 2015.

References-Contd. Malone, R. E., Yerger, V. B., McGruder, C., & Froelicher, E. (2006). " It's like Tuskegee in reverse": A case study of ethical tensions in institutional review board review of community-based participatory research. American Journal of Public Health, 96(11), 1914-1919.Keith-Spiegel, P., & Koocher, G. P. (2005). The IRB paradox: could the protectors also encourage deceit?. Ethics & Behavior, 15(4), 339-349.Azar, B. (2002). Ethics at the cost of research. Monitor on Psychology, 33(2), 38-40.Khanlou, N., & Peter, E. (2005). Participatory action research: considerations for ethical review. Social Science & Medicine, 60(10), 2333-2340.Flicker, S., Travers, R., Guta, A., McDonald, S., & Meagher, A. (2007). Ethical dilemmas in community-based participatory research: Recommendations for institutional review boards. Journal of Urban Health, 84(4), 478-493.Cook, Ann Freeman, and Helena Hoas. "Protecting Research Subjects: Irbs In A Changing Research Landscape." IRB: Ethics & Human Research 33.2 (2011): 14-19. Academic Search Complete. Web. Klitzman, Robert. "From Anonymity To "Open Doors": IRB Responses To Tensions With Researchers." BMC Research Notes 5.1 (2012): 347-357. Academic Search Complete. Web.Guta, Adrian, et al. "'Walking Along Beside the Researcher': How Canadian REBs/IRBs are Responding to the Needs of Community-based Participatory Research." Journal of Empirical Research on Human Research Ethics 2012: 15. JSTOR Journals. Web. "Making Human Subject Protection Training Community Responsive: Experiences Delivering On The Community-Based Participatory Research Promise." Progress In Community Health Partnerships: Research, Education, And Action 2 (2014): 215. Project MUSE. Web. https://intentionalmuseum.files.wordpress.com/2014/03/1609_color_nit-picking_irb.jpg