Online Program

When irbs still disagree: Challenges to conducting sexual health research with sexually-active adolescents, 2012-2013

Monday, November 4, 2013 : 8:30 a.m. - 8:45 a.m.

Bridgette Mercedez Brawner, PhD, APRN, Department of Family and Community Health, University of Pennsylvania School of Nursing, Philadelphia, PA
Issues: Sexual health research with adolescents frequently involves several regulatory bodies for approval. Obtaining clearance is challenging when multiple institutional review board (IRBs) disagree on parental consent and study benefit. Description: We are conducting a study to develop and test an HIV/STI prevention and testing program for Black, heterosexually-active adolescents with mental health diagnoses (e.g., attention deficit disorders and depression). Preliminary work with this same demographic of at-risk youth suggested that a waiver of parental consent was appropriate to maintain participants' confidentiality, to facilitate enrollment, and to collect data to inform HIV prevention strategies. Lessons Learned: The protocol was reviewed by: 1) the academic institution IRB, and 2) local health department IRB; they disagreed on what constituted “minimal risk,” the appropriateness of the parental consent waiver, and possible liability due to a positive HIV/STI diagnosis. Guidance was sought from an objective local youth social justice legal entity; they determined that the proposed research was congruent with state laws and healthcare practices, and that proposed participants are capable of providing informed consent without parental permission. The protocol was approved after 11 months. Recommendations: This case highlights continued challenges faced in sexual health research with minors. It also underscores the importance of balancing IRB human subjects concerns with adolescent's legal rights to privacy and confidentiality. Sexual health researchers working with adolescents, particularly those considered 'vulnerable', should consider strategies to address these issues, ensure appropriate protections, and avoid protocol delays which may hinder goals to prevent new cases of HIV among at-risk youth.

Learning Areas:

Advocacy for health and health education
Diversity and culture
Ethics, professional and legal requirements
Planning of health education strategies, interventions, and programs
Public health or related laws, regulations, standards, or guidelines
Social and behavioral sciences

Learning Objectives:
Discuss potential challenges to conducting sexual health research with adolescents Differentiate the role of PIs, funders and local IRBs in the project determination process List strategies to allay concerns and ensure participant safety while accomplishing the research objectives

Keyword(s): Research Ethics, HIV/AIDS

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have been involved in several local and international research projects focused on improving health and reducing risk behaviors among racial and ethnic minority adolescents. My program of research is devoted to ensure that these populations have access to evidence-based sexual health assessment, and bio-behavioral HIV/STI risk reduction interventions. I hope that my research and practice will inform policies that shape the healthcare delivery system for stigmatized and disenfranchised populations.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.