Patients come from populations and populations contain patients. A two-stage scientific and ethics review: The next adaptation for single institutional review boards

Alzheimer's and Dementia

Volumn 13, Issue 8, 2017, Pages 940-946

  Knopman, David ^a   Alford, Eli ^b   Tate, Kaitlin ^c   Long, Mark ^b   Khachaturian, Ara S ^d  

^a Mayo Clinic College of Medicine   (United States)

^b Schulman IRB   (United States)

^c Schulman Associates IRB   (United States)

^d National Biomedical Research Ethics Council   (United States)

Author keywords

Alzheimer's; Clinical trial; Dementia; EMEA; Ethics; FDA; Intervention; IRB; Prevention; Therapeutic; Treatment

Indexed keywords

FEASIBILITY STUDY; HUMAN; INFORMED CONSENT; INSTITUTIONAL REVIEW; MEDICAL RESEARCH; MEMORY DISORDER; MOOD DISORDER; MOTOR DYSFUNCTION; OPEN STUDY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROFESSIONAL STANDARD; RESEARCH ETHICS; SHORT SURVEY; VULNERABLE POPULATION; ALZHEIMER DISEASE; CLINICAL TRIAL (TOPIC); DEMENTIA; ETHICS; MULTICENTER STUDY (TOPIC); PROCEDURES;

ALZHEIMER DISEASE; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; DEMENTIA; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; MULTICENTER STUDIES AS TOPIC;

EID: 85022195924     PISSN: 15525260     EISSN: 15525279     Source Type: Journal    
DOI: 10.1016/j.jalz.2017.06.001     Document Type: Short Survey

References (21)

1. Khachaturian, Z.S., A roadmap for the prevention of dementia II: Leon Thal Symposium 2008. Alzheimers Dement 5 (2009), 85–92.
2. Khachaturian, Z.S., Petersen, R.C., Gauthier, S., Buckholtz, N., Corey-Bloom, J.P., Evans, B., et al. A roadmap for the prevention of dementia: The inaugural Leon Thal Symposium. Alzheimers Dement 4 (2008), 156–163.
3. US Department of Health and Human Services. Federal Policy for the Protection of Human Subjects (“Common Rule”). Available at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html. Accessed June 4, 2017.
4. US Department of Health and Human Services. Institutional Review Board. Code of Federal Regulations Title 21 Part 56. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56. Accessed June 4, 2017.
5. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (E6(R2)), Current Step 4 version dated 9 November 2016. Available at: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/…/E6/E6_R2__Step_4.pdf. Accessed June 4, 2017.
6. Menikoff, J., The paradoxical problem with multiple-IRB review. N Engl J Med 363 (2010), 1591–1593.
7. Klitzman, R., Pivovarova, E., Lidz, C.W., Single IRBs in multisite trials: Questions posed by the New NIH Policy. JAMA 317 (2017), 2061–2062.
8. Ravina, B., Deuel, L., Siderowf, A., Ray Dorsey, E., Local IRB review of a multicenter trial: local costs without local context. Ann Neurol 67 (2010), 258–260.
9. US Department of Health and Human Services. National Cancer Institute Central Institutional Board Initiative. Available at: https://ncicirb.org. Accessed June 5, 2017.
10. US Department of Health and Human Services. National Institutes of Health. Combined NeuroScience Institutional Review Board. Available at: https://neuroscience.nih.gov/irb/Home.aspx. Accessed June 5, 2017.
11. US Department of Veterans Affairs. Office of Research and Development. Available at: https://www.research.va.gov/vacentralirb/. Accessed June 5, 2017.
12. US Department of Health and Human Services. Final NIH policy on the use of a single institutional review board for multi-site research, June 21, 2016. Available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html. Update June 21, 2016. Accessed June 3, 2017.
13. Ervin, A.M., Taylor, H.A., Ehrhardt, A., NIH policy on single-IRB review—a new era in multicenter studies. N Engl J Med 375 (2016), 2315–2317.
14. US House of Representatives. House Resolution 6. 21st Century Cures Act, 114th Congress (2015-2016). Available at: https://www.congress.gov/bill/114th-congress/house-bill/6. Accessed June 3, 2017.
15. Final Revisions to the Common Rule, Federal Register Volume 82, Number 12 (Thursday, January 19, 2017), Pages 7149–7274. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html. Accessed June 3, 2017.
16. US Department of Health and Human Services. Criteria for IRB approval of research. Code of Federal Regulations, Title 21 Sec. 56.111. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.111. Accessed June 3, 2017.
17. US Department of Health and Human Services. Criteria for IRB approval of research. Code of Federal Regulations, Title 45 Sec. 46.111. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.111. Accessed June 3, 2017.
18. Department of Health and Human Services, Cancer Center Support Grants (CCSGs) for NCI-designated cancer centers (P30). Available at: https://grants.nih.gov/grants/guide/pa-files/PAR-12-298.html. Update 26 September 2012. Accessed June 3, 2017.
19. Koski, G., Chapter 24 – Ethical issues in translational research and clinical investigation, clinical and translational science. 2nd ed., 2017, Principles of Human Research, Burlington, MA, 441–456.
20. Smart IRB. Available at: https://smartirb.org/. Accessed June 5, 2017.
21. Federal Register Volume 82, Number 12 (Thursday, January 19, 2017) Page 7154. Available at: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf. Accessed June 3, 2017.