Institutional Review Board Background
Genetic Alliance’s Institutional Review Board was established in 2003, to meet an emerging need. It was clear at that time, that disease advocacy organizations (DAO) were increasingly conducting their own research involving human participants. That research was better served by having institutional review board approval. The university, corporate and independent institutional review boards of the time were not affordable, and often were unable to assess the issues inherently unique to disease advocacy organizations as the ‘institution’.

Experts in the field of human participant protections from the Office of Human Research Protection (OHRP), the National Institutes of Health, the Department of Defense and the Centers for Disease Control and Prevention assisted Genetic Alliance in establishing this unique IRB. Its registration number with OHRP is IORG0003358. As a result of low overhead, generous IRB members who believe in empowering novel methods to accelerate clinical science, and innovative efficiencies, the cost for each review is very reasonable and far below other independent IRBs.

Programs and protocols:
See below

IRB Composition:
The IRB is composed of five individuals, we are seeking an additional member, as well as a chair. All work in the health field, and most have first hand experience with genetic research, either through clinical or ELSI research. The members include: a priest ethicist, a disease advocate, a lawyer, a health information technology specialist and a clinical researcher.

Job Description for IRB Chairperson
The IRB is registered with OHRP and follows all of the regulations as stipulated by 45 CFR Part 46. Genetic Alliance IRB is accepting applications for chair of the IRB.

The chair will:

• Oversee the IRB’s activities
• Prepare and lead full IRB reviews when necessary (approximately 1 per month)
• Perform expedited reviews when they are appropriate (approximately 2 or 3 per month)
• Assure the IRB is up to date and in compliance with current laws and regulations
• Educate new IRB members in any areas in need of assistance (turnover is very rare, most members are in their 10th year of service)
• Sign resulting letters of approval or denial
• Liaison with the BioTrust Ethics Team

Approximate time commitment:
This is highly variable, but has been increasing over the years as research conducted by and with DAOs increases. In the past year, the chair has worked approximately 2 hours per week, average, though some weeks were more and some were less.

Volume:
The IRB chair has reviewed approximately 4 protocols a year, but we expect that to increase with the success of Registries for All. Most of the protocols we receive are eligible for expedited review. We expect there to be one new protocol per month. The chair has reviewed about four continuing protocols per year, and all of these have been the template based Genetic Alliance Registry and BioBank member protocols. These are standard documents that member organizations complete every year for renewal.

Support:
Administrative support is provided by the Genetic Alliance Registry and BioBank director, the Genetic Alliance Chief of Staff, and the Genetic Alliance Office Manager. If legal advice is necessary, Genetic Alliance will secure it. Genetic Alliance has relationships with several lawyers who have human participant protections, regulatory, and clinical trial experience. If the protocol requires special expertise, Genetic Alliance recruits the necessary experts.

Qualifications:

• Commitment to enabling the empowered participant at the center of clinical science.
• Thorough knowledge of OHRP, DHHS, and FDA regulations and ability to keep up to date.
• At least 5 years service on an IRB or equivalent.

Compensation:
Commensurate with experience, hourly rate.

To apply:
Please send a cover letter articulating your interest; your experience with participant-centric endeavors and participant engagement; and your IRB experience and training. Attach your CV. Please state your hourly wage. Send to: Abbie Moore, amoore@geneticalliance.org

Programs:
Genetic Alliance Registry and BioBank
The IRB oversees the Genetic Alliance Registry and BioBank (GARB) studies. This is a lay owned and managed, cross disease cooperative platform for disease advocacy organizations to manage clinical data and samples and the resulting studies. The IRB approves the template documents, annually reviews the operations of the various disease groups in GARB and reviews any studies the DAO conduct. In addition, the IRB reviews studies on an ad hoc basis – from DAO, students, genetic counselors and even companies who are engaging in work that benefits the community. In all cases, the researcher(s) and/or participants are DAO and their members.

BioTrust: the Larger Context
In the last year, the IRB has been joined by a sister body for governance and oversight of Genetic Alliance and DAO research and research infrastructure. The BioTrust Ethics Team* has evolved at Genetic Alliance in three ways: 1) an organic response to evolving needs as DAO and affected individuals begin to engage differently in the networked information age; 2) propelled by ad hoc opportunities that have arisen that constitute research enabling platforms and not studies, i.e., Free the Data and Reg4ALL; and 3) specific to the challenge of doing ethical research, and making sure it is sustainable as part of the definition of ethical. As the BioTrust of Genetic Alliance has grown as home to all of the translational and clinical science of Genetic Alliance, the need for an ethics team to lead a potential archetype for consumer engagement in translational biomedical research emerged.

BioTrust remains to be defined in its entirety. At the present time, we believe that individuals/consumers/citizens/public are rightful participants in their own health, including in the translational science necessary to catalyze the therapies and diagnostics that these individuals and communities need today and in the future. BioTrust holds the space for individuals, families and communities to enter into presenting themselves and uniting their ‘donations’ in a confederated whole. As walking compendium of information, the very information we all desperately need to solve the thorniest issues in health and disease, we embody profound truths that must be respected and also plumbed, so that biomedical research is accelerated for the benefit of all.

It is well established that trust must form the foundation of any truly ethical and just system, and that the formulation of such a basis must be done in true participant engagement. BioTrust offers an opportunity to construct such a system. It offers space and openness to both establish a practical series of programs, processes, methodologies and entities, and to iteratively study and improve such activities. It offers a safe space to test the concepts and theories put forth by the thought leaders in this arena, and at the same time to make practical and pragmatic contributions to improving health. This program is a living laboratory, a learning system, for accelerating the amazing theories in the papers referenced above, at the same time as applying lessons learned.

*The BioTrust Ethics Team:
Kelly Edwards, Chair, University of Washington Nicholas Anderson, University of Washington
Greg Biggers, Genomera
Leila Jamal, Johns Hopkins University
Jane Kaye, Oxford University
Kieran O’Doherty, University of Guelph
Suzanne Vernon, CFIDS Association of America
David Winickoff, University of California at Berkeley