3 | A Proposal by the U.S. Food and Drug Administration for Reliance on Single Institutional Review Boards: Proceed Only With Caution. (Spellecy R, Thompson N, Nattinger AB) Ann Intern Med 2024 Mar;177(3):383-384 |
2 | Research During COVID-19: Reflections From an Institutional Review Board Office. (Busse K, Griffin S, Spellecy R) WMJ 2023 Dec;122(5):434-436 |
1 | Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial. (Martin SL, Allman PH, Dugoff L, Sibai B, Lynch S, Ferrara J, Aagaard K, Zornes C, Wilson JL, Gibson M, Adams M, Longo SA, Staples A, Saade G, Beche I, Carter EB, Owens MY, Simhan H, Frey HA, Khan S, Palatnik A, August P, Irby L, Lee T, Lee C, Schum P, Chan-Akeley R, Duhon C, Rincon M, Gibson K, Wiegand S, Eastham D, Oparil S, Szychowski JM, Tita A, Chronic Hypertension and Pregnancy Consortium) Am J Obstet Gynecol MFM 2023 Jun;5(6):100861 1 Citation |
1 | Invited Peer Commentary: Min-Fu Tsan: Improving the Quality and Performance of Institutional Review Boards in the U.S. Through Performance Measurements. (Spellecy R) J Empir Res Hum Res Ethics 2021 Dec;16(5):485-486 |
2 | The History of Human Subjects Research and Rationale for Institutional Review Board Oversight. (Spellecy R, Busse K) Nutr Clin Pract 2021 Jun;36(3):560-567 21 Citations |
3 | Characterizing Current Attitudes and Practices for Human Subject Safety in Studies Involving Pupil Dilation. (Szpernal J, Carroll J, Spellecy R, Bachman Groth JA) J Empir Res Hum Res Ethics 2021;16(1-2):54-64 1 Citation |
2 | The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time. (Spellecy R, Eve AM, Connors ER, Shaker R, Clark DC) J Empir Res Hum Res Ethics 2018 Oct;13(4):432-437 9 Citations |
1 | Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities. (Prusaczyk B, Cherney SM, Carpenter CR, DuBois JM) Clin Gerontol 2017;40(1):63-73 78 Citations |
1 | Where does innovation adaptation end and experimentation begin? (Jones JW, McCullough LB) J Vasc Surg 2015 Oct;62(4):1074-5 1 Citation |
1 | Variability in IRBs regarding parental acceptance of passive consent. (Higgerson RA, Olsho LE, Christie LM, Rehder K, Doksum T, Gedeit R, Giuliano JS Jr, Brennan B, Wendlandt R, Randolph AG, PALISI PICFlu Study Investigators) Pediatrics 2014 Aug;134(2):e496-503 11 Citations |
1 | Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature. (Check DK, Weinfurt KP, Dombeck CB, Kramer JM, Flynn KE) Clin Trials 2013 Aug;10(4):560-7 46 Citations |
1 | Medical students as human subjects in educational research. (Sarpel U, Hopkins MA, More F, Yavner S, Pusic M, Nick MW, Song H, Ellaway R, Kalet AL) Med Educ Online 2013 Feb 25;18:1-6 24 Citations |
1 | Using central IRBs for multicenter clinical trials in the United States. (Flynn KE, Hahn CL, Kramer JM, Check DK, Dombeck CB, Bang S, Perlmutter J, Khin-Maung-Gyi FA, Weinfurt KP) PLoS One 2013;8(1):e54999 56 Citations |
1 | More than cheating: deception, IRB shopping, and the normative legitimacy of IRBs. (Spellecy R, May T) J Law Med Ethics 2012;40(4):990-6 9 Citations |
1 | Relationships between community-based processes for research ethics review and institution-based IRBs: a national study. (Shore N, Drew E, Brazauskas R, Seifer SD) J Empir Res Hum Res Ethics 2011 Jun;6(2):13-21 31 Citations |
1 | Oversight and management of a cell therapy clinical trial network: experience and lessons learned. (Moyé LA, Sayre SL, Westbrook L, Jorgenson BC, Handberg E, Anwaruddin S, Wagner KA, Skarlatos SI) Contemp Clin Trials 2011 Sep;32(5):614-9 5 Citations |
1 | Understanding community-based processes for research ethics review: a national study. (Shore N, Brazauskas R, Drew E, Wong KA, Moy L, Baden AC, Cyr K, Ulevicus J, Seifer SD) Am J Public Health 2011 Dec;101 Suppl 1(Suppl 1):S359-64 36 Citations |
1 | Viewpoint: IRBs, hospital ethics committees, and the need for "translational informed consent". (May T, Craig JM, Spellecy R) Acad Med 2007 Jul;82(7):670-4 17 Citations |
1 | The conduct of clinical research under the HIPAA Privacy Rule. (McMaster WC, Sale K, Andersson GB, Bostrom MP, Gebhardt MC, Trippel SB, Clark DC) J Bone Joint Surg Am 2006 Dec;88(12):2765-70 1 Citation |
1 | Unproven or unsatisfactory versus equipoise in emergency research with waived consent. (Spellecy R) Am J Bioeth 2006;6(3):44-5 7 Citations |
1 | Emergency research and consent: keeping the exception from undermining the rule. (Derse AR) Am J Bioeth 2006;6(3):36-7; discussion W49-50 8 Citations |
1 | Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience. (Mosesso VN Jr, Brown LH, Greene HL, Schmidt TA, Aufderheide TP, Sayre MR, Stephens SW, Travers A, Craven RA, Weisfeldt ML, PAD Trial Investigators) Resuscitation 2004 Apr;61(1):29-36 82 Citations |