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Current opinion
Variations in institutional review board processes and consent requirements for trauma research: an EAST multicenter survey
  1. Jeffry Nahmias1,
  2. Areg Grigorian1,
  3. Scott Brakenridge2,
  4. Randeep S Jawa3,
  5. Daniel N Holena4,
  6. John Varujan Agapian5,
  7. Brandon Bruns6,
  8. Paul J Chestovich7,
  9. Bruce Chung8,
  10. Jonathan Nguyen9,
  11. Carl I Schulman10,
  12. Kristan Staudenmayer11,
  13. Rachel Dixon12,
  14. Jason W Smith13,
  15. Andrew C Bernard14,
  16. Jose L Pascual4
  1. 1Department of Surgery, University of California, Irvine, California, USA
  2. 2Department of Surgery, University of Florida Health Science Center, Gainesville, Florida, USA
  3. 3Department of Surgery, Stony Brook University Health Sciences Center School of Medicine, Stony Brook, New York, USA
  4. 4Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA
  5. 5Department of Surgery, University of California, Riverside, Rancho Cucamonga, California, USA
  6. 6Department of Surgery, University of Maryland, Baltimore, Maryland, USA
  7. 7Department of Surgery, University of Nevada, Las Vegas, Nevada, USA
  8. 8Department of Surgery, Maine Medical Center, Portland, Maine, USA
  9. 9Department of Surgery, Morehouse School of Medicine, Atlanta, Georgia, USA
  10. 10Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA
  11. 11Department of Surgery, Stanford University, Stanford, California, USA
  12. 12Eastern Association for the Surgery of Trauma, Chicago, Illinois, USA
  13. 13Department of Surgery, University of Louisville, Louisville, Kentucky, USA
  14. 14Department of Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA
  1. Correspondence to Dr Jeffry Nahmias, Division of Trauma, Burns and Surgical Critical Care, Department of Surgery, University of California, Irvine Medical Center, Irvine CA 92697-3950, USA; jnahmias{at}uci.edu

Abstract

Oversight of human subject research has evolved considerably since its inception. However, previous studies identified a lack of consistency of institutional review board (IRB) determination for the type of review required and whether informed consent is necessary, especially for prospective observational studies, which pose minimal risk of harm. We hypothesized that there is significant inter-institution variation in IRB requirements for the type of review and necessity of informed consent, especially for prospective observational trials without blood/tissue utilization. We also sought to describe investigators’ and IRB members’ attitudes toward the type of review and need for consent. Eastern Association for the Surgery of Trauma (EAST) and IRB members were sent an electronic survey on IRB review and informed consent requirement. We performed descriptive analyses as well as Fisher’s exact test to determine differences between EAST and IRB members’ responses. The response rate for EAST members from 113 institutions was 13.5%, whereas a convenience sample of IRB members from 14 institutions had a response rate of 64.4%. Requirement for full IRB review for retrospective studies using patient identifiers was reported by zero IRB member compared with 13.1% of EAST members (p=0.05). Regarding prospective observational trials without blood/tissue collection, 48.1% of EAST members reported their institutions required a full IRB review compared with 9.5% of IRB members (p=0.01). For prospective observational trials with blood/tissue collection, 80% of EAST members indicated requirement to submit a full IRB review compared with only 13.6% of IRB members (p<0.001). Most EAST members (78.6%) stated that informed consent is not ethically necessary in prospective observational trials without blood/tissue collection, whereas most IRB members thought that informed consent was ethically necessary (63.6%, p<0.001). There is significant variation in perception and practice regarding the level of review for prospective observational studies and whether informed consent is necessary. We recommend future interdisciplinary efforts between researchers and IRBs should occur to better standardize local IRB efforts.

Level of evidence IV.

  • informed consent
  • observational study
  • medical ethics

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/tsaco-2018-000176

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    Footnotes

    • Contributors JeN: literature search, study design, data collection, data analysis, data interpretation, writing, critical revision. AG: literature search, data collection, data analysis, data interpretation, writing, critical revision. SB: literature search, study design, data collection, data analysis, data interpretation, writing, critical revision. RSJ: literature search, study design, data interpretation, writing, critical revision. DNH: study design, data analysis, data interpretation, writing, critical revision. JVA: study design, data interpretation, writing, critical revision. BB: study design, data collection, data interpretation, writing, critical revision. PJC: study design, data collection, data interpretation, writing, critical revision. BC: study design, data interpretation, writing, critical revision. JoN: study design, data interpretation, writing, critical revision. CIS: literature search, study design, data interpretation, writing, critical revision. KS: study design, data interpretation, writing, critical revision. RD: study design, data collection, data interpretation, writing, critical revision. JWS: study design, data interpretation, writing, critical revision. ACB: study design, data interpretation, writing, critical revision. JLP: literature search, study design, data collection, data interpretation, writing, critical revision.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval University of California institutional review board.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement The raw data files for IRB and EAST survey respondents are available, if the EAST Multicenter Trials (MCT) Committee allows for these to be dispersed.