References
- 21st Century Cures Act. 2016. Public Law 114-255. 114th Congress.
- Association for the Accreditation of Human Research Protection Programs. 2018. Accredited organizations. http://www.aahrpp.org/learn/find-an-accredited-organization.
- Association for the Accreditation of Human Research Protection Programs. 2017. 2016 metrics on human research protection program performance for academic institutions. 1–16. https://admin.aahrpp.org/Website%20Documents/2016%20All%20Organizations.pdf.
- Bian, J., M. Xie, W. Hogan, L. Hutchins, U. Topaloglu, C. Lane, J. Holland, T. Wells, Y. Fan, and M. Baker. 2014. CLARA: An integrated clinical research administration system. Journal of the American Medical Informatics Association 21 (e2):e369–e373. doi: 10.1136/amiajnl-2013-002616.
Deidentified
- Citizens For Responsible Care and Research. 2020. Commercial institutional review boards (IRBs). http://www.circare.org/info/commercialirb.htm.
- CDISC. 2018. Data exchange standards. https://www.cdisc.org/standards/data-exchange.
- Candilis, P. J., C. W. Lidz, P. S. Appelbaum, R. M. Arnold, W. Gardner, S. Garverich, A. J. Grudzinskas Jr., and L. J. Simon. 2012. The silent majority: Who speaks at IRB meetings? IRB 34 (4):15.
- Ervin, A.-M., H. A. Taylor, and S. Ehrhardt. 2016. NIH policy on single-IRB review—A new era in multicenter studies. The New England Journal of Medicine 375 (24):2315–7. doi: 10.1056/NEJMp1608766.
- Greene, S. M., and A. M. Geiger. 2006. A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval. Journal of Clinical Epidemiology 59 (8):784–90. doi: 10.1016/j.jclinepi.2005.11.018.
- He, S., J. R. Botkin, and J. F. Hurdle. 2015. An analysis of information technology adoption by IRBs of large academic medical centers in the United States. Journal of Empirical Research on Human Research Ethics 10 (1):31–6. doi: 10.1177/1556264614560146.
- He, S., S. P. Narus, J. C. Facelli, L. M. Lau, J. R. Botkin, and J. F. Hurdle. 2014. A domain analysis model for eIRB systems: Addressing the weak link in clinical research informatics. Journal of Biomedical Informatics 52:121–9. doi: 10.1016/j.jbi.2014.05.003.
- Hood, M. N., B. Gugerty, R. Levine, and V. B. Ho. 2005. Computerized information management for institutional review boards. Computers, Informatics, Nursing (CIN) 23 (4):190–8. doi: 10.1097/00024665-200507000-00005.
- IRB Reliance Exchange. 2018. Using the IRB reliance exchange as the reviewing IRB. https://www.irbexchange.org/p/wp-content/uploads/2018/06/IREx_ReviewingIRB_QuickGuide_20180621.pdf.
- Lidz, C. W., P. S. Appelbaum, R. Arnold, P. Candilis, W. Gardner, S. Myers, and L. Simon. 2012. How closely do institutional review boards follow the common rule? Academic Medicine 87 (7):969.
- Lidz, C. W., E. Pivovarova, P. Appelbaum, D. F. Stiles, A. Murray, and R. L. Klitzman. 2018. Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff. AJOB Empirical Bioethics 9 (3):164–72. doi: 10.1080/23294515.2018.1510437.
- Moon, M. R. 2017. Can central IRBs replace local review? The Journal of Law, Medicine & Ethics 45 (3):348–51.
- National Institutes of Health. 2015. Comments on FR Doc #2015-21756: Federal policy for the protection of human subjects. https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&dct=PS&D=HHS-OPHS-2015-0008.
- National Institutes of Health. 2016. Final NIH policy on the use of a single institutional review board for multi-site research. https://grants.nih.gov/grants/guide/notice-files/not-od-16-094.html.
- National Institutes of Health. 2016. NOT-OD-16-109: Scenarios to illustrate the use of direct and indirect costs for single IRB review under the NIH policy on the use of a single IRB for multi-site research. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-109.html.
- National Institutes of Health. 2017. Frequently asked questions: Single IRB policy for multi-site research. https://grants.nih.gov/grants/policy/faq_single_IRB_policy_research.htm#5252.
- Office for Human Research Protections. 2018. IRB registration portal. https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/index.html.
- Public Responsibility in Medicine & Research. 2018. http://www.primr.org.
- Taylor, H. A., and A. M. Ervin. 2017. A measure of effectiveness is key to the success of sIRB policy. The American Journal of Bioethics 17 (7):41–3. doi: 10.1080/15265161.2017.1328537.
- The CDISC Protocol Representation Group (PRG). 2009. The protocol representation model version 1.0. https://www.cdisc.org/system/files/members/standard/foundational/protocol/protocol_representation_model_version_1.0.zip.
- Turisco, F., D. Keogh, C. Stubbs, J. Glaser, and W. F. Crowley. 2005. Current status of integrating information technologies into the clinical research enterprise within US academic health centers: Strategic value and opportunities for investment. Journal of Investigative Medicine 53 (8):425–33. doi: 10.2310/6650.2005.53806.
- University of Vanderbilt. 2018. About | IRB reliance exchange (“IREx”). https://www.irbexchange.org/p/about/.
- Vadakin, A., and B. Hinkson. 2012. Organizing and accelerating the clinical research process from the beginning: The CDISC protocol representation model and toolkit. CDISC Journal. https://www.cdisc.org/system/files/all/article/application/pdf/protocol_representation_model_and_toolkit_vadakin__hinkson.pdf.