21
Jun2011

by Wendy Tate, PSM, CIP

I can’t believe it’s been almost seven months since the 2010 Advancing Ethical Research (AER) Conference in San Diego, CA, and that we are already looking ahead to the 2011 AER Conference in National Harbor, MD.

Since coming home, there have been so many good articles on Ampersand covering topics such as the Certified Institutional Review Board (IRB) Professional (CIP®) exam, networking, repositories, Office for Human Research Protections guidance, and informed consent. This made it hard to find a good post-AER topic to write about, but ultimately, it made me remember what this whole process is about: protecting human subjects. So, I decided to summarize what I have brought back from AER by reciting my ABCs.

Ask subjects if they want to receive research results or participate in unspecified future research instead of assuming that the IRB knows what is in the best interest of the subjects

Bridge the gap between the IRB and the research community to create a partnership that promotes cutting edge, high-quality, ethical human research

Community-based participatory research truly partners the community with the researchers, builds trust, and promotes results that everyone can benefit from

Develop and use robust assurance tools to ensure that your human research protections program (HRPP) does not stagnate

Equivalent protections are a legitimate way to protect human subjects outside of the federal regulations, if you have “unchecked your box”

Find resources in your academic community to create a more robust review process within and outside of the IRB

Get CIP certified; it adds credibility to you and your program

Have good communication networks and processes in place with other compliance units in your institution to ensure 360-degree human subjects protections

Informed consent is not informed unless the language (in both oral and written forms) is understandable to the subject

Justice, beneficence, and respect for persons must be first in mind when reviewing human research

Keep educating IRB members, HRPP staff, researchers, and the community about research and subject rights

Listen to and learn from everyone’s story

Make it a priority to send new staff members to the AER Conference and IRB 101sm

National Institutes of Health will challenge IRBs across the nation to rethink specimen research and biorepositories

Others have dealt and/or are dealing with the same problems and issues as you, so don’t be afraid to discuss your weaknesses

Pregnant women are not always vulnerable and should be included in clinical trials

Quality assurance within the IRB helps assure researchers that you recognize their concerns and are addressing them

Regulations are not perfect, and it is not taboo to point out their faults and limitations

Solicit permission from other institutions to use and re-purpose their forms; don’t re-invent the wheel

Take your staff to the AER Conference and cover as many of the sessions as possible so that everyone learns

Unchecking the box on the Federalwide assurance allows HRPPs to be creative and innovative

Validate techniques with other institutions and compare your results

Write up your professional development experience to teach others who did not participate and to solidify the information you obtained

Xenodochial people make up PRIM&R and make you feel like old friends before the conference is over

Yesterday’s answers are not enough as research becomes more global and more interdisciplinary

Zeal for your career in human subjects protection may be nerdy, but not uncommon as demonstrated by the 2000+ people who attended the 2010 AER Conference

Member registration is now open for the 2011 AER Conference. Learn more about this year's conference by visiting our website. Nonmember registration will open on June 29, 2011.

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