IRB practices and policies regarding the secondary research use of biospecimens

Goldenberg, Aaron J.; Maschke, Karen J.; Joffe, Steven; Botkin, Jeffrey R.; Rothwell, Erin; Murray, Thomas H.; Anderson, Rebecca; Deming, Nicole M.; Rosenthal, Beth; Rivera, Suzanne M.

doi:10.1186/s12910-015-0020-1

Cited by 23 publications

(20 citation statements)

References 17 publications

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“…However, adapting to new modalities of research is a challenging endeavour for IRB members everywhere. We were able to link how information on secondary use, sharing of material and data, and recontacting participants is conveyed in earlier analysis on a sample of Canadian IRB documents, with the opinion of a group of Canadian IRB members and with results published elsewhere on the same subjects among the public and scientists [11][12][13]. The latter confirms the relevance on the topics and information independently of type and number of participants, and their geographical location.…”

Section: Resultssupporting

confidence: 60%

“…However, it is not clear to the participants of our survey how these explanationsand thus the options for secondary use -would impact the availability of data necessary for collaborative genetic studies. Results from a survey among IRB administrators conducted by Goldberg et al explain that when it comes to secondary use in genetic research, IRBs are not consistent in their "protocol review, risk assessment, and data sharing, especially when specimens from biobanks are not anonymized" [11]. The majority of respondents to questions on the matter of data sharing are in favour of providing options for this endeavour.…”

Section: Discussionmentioning

confidence: 99%

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Consenting for Current Genetic Research: Views of Canadian Institutional Review Board Members

Groisman¹,

Godard

2015

J Clinic Res Bioeth

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The widespread use of next generation sequencing (NGS) technologies in genetic research protocols creates a need for sequencing material that has been already collected, be it for similar or different purposes, in addition to increasing the need for sharing both material and the genetic generated data to enrich study results. Along with this comes the need to recontact participants for a variety of reasons where consent for unanticipated use and obtaining additional health information are only some examples. Following an earlier content analysis on a sample of Canadian Institutional Review Boards (IRB) consent form templates and accompanying guidelines, and IRBapproved consent forms, we developed an online survey addressing the opinions and experiences of Canadian IRB members on the use of NGS in research. We report herein the results pertaining to secondary use, sharing of material and data and recontacting participants. Participants in our survey agree with the need for clear identification on the matter of secondary use on consent form documents as well as the importance of differentiating use of material from the generated data. Our responders seem to be unsure how these separate options could affect the research enterprise. Respondents to our study agree with study participants opinions obtained elsewhere about the importance of providing options when it comes to share their data. While all responders agree on the importance of increasing grounds for recontacting, not all accept a clause allowing researchers to contact participants by default and giving always the possibility to refuse any further communication at time of recontact. Furthermore, our survey allowed us to make connections between the information stated on consent documents resulting from our earlier analysis with member's views of said Boards. Adapting to new modalities of research is a challenging endeavour for IRB members. Continuous empirical research will allow the ethical oversight of research projects to keep pace with technological changes, simultaneously ensuring protection of human participants.

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Section: Resultssupporting

confidence: 60%

Section: Discussionmentioning

confidence: 99%

Consenting for Current Genetic Research: Views of Canadian Institutional Review Board Members

Groisman¹,

Godard

2015

J Clinic Res Bioeth

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“…Likewise, all institutions performing research of any type involving human subjects are required to have an Institutional Review Board (IRB)-approved protocol, the key component differentiating the latter from the former being the informed consent process, which attempts to assure subjects’ right to choose participation in a given study on the basis of the risks and benefits as presented by the researchers (Kane & Gallo, 2017, Goldenberg et al, 2015). Note that while IACUC and IRB are guidelines used within the United States, similar ethical committee guidelines are followed by much of the international community (Ghooi, 2014, Grady, 2015, Gettayacamin & Retnam, 2017, Newcomer & McGlone, 2015).…”

Section: Practice Guidelinesmentioning

confidence: 99%

Comparing human and mouse salivary glands: A practice guide for salivary researchers

et al. 2018

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Mice are a widely utilized in vivo model for translational salivary gland research but must be used with caution. Specifically, mouse salivary glands are similar in many ways to human salivary glands (i.e., in terms of their anatomy, histology, and physiology) and are both readily available and relatively easy and affordable to maintain. However, there are some significant differences between the two organisms, and by extension, the salivary glands derived from them must be taken into account for translational studies. The current review details pertinent similarities and differences between human and mouse salivary glands and offers practical guidelines for using both for research purposes.

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“…Hesitation among prospective donors to consent to future use of their leftover biosamples raises issues on the type of consent forms researchers should develop. Whereas a research-specific consent process limits the use of biospecimens for very specific and pre-defined research purposes, a general-purpose consent process allows for a broader array of research purposes and the potential for future collaborative research [ 5 , 32 ]. In addition to these two types there are also tiered consents which allow the donor to consent to a menu of potential future uses of their samples, and the option re-contact to request future permissions [ 35 ].…”

Section: Introductionmentioning

confidence: 99%

To Share or Not to Share? A Survey of Biomedical Researchers in the U.S. Southwest, an Ethnically Diverse Region

Oushy

Palacios

Holden³

et al. 2015

PLoS ONE

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BackgroundCancer health disparities research depends on access to biospecimens from diverse racial/ethnic populations. This multimethodological study, using mixed methods for quantitative and qualitative analysis of survey results, assessed barriers, concerns, and practices for sharing biospecimens/data among researchers working with biospecimens from minority populations in a 5 state region of the United States (Arizona, Colorado, New Mexico, Oklahoma, and Texas). The ultimate goals of this research were to understand data sharing barriers among biomedical researchers; guide strategies to increase participation in biospecimen research; and strengthen collaborative opportunities among researchers.Methods and PopulationEmail invitations to anonymous participants (n = 605 individuals identified by the NIH RePORT database), resulted in 112 responses. The survey assessed demographics, specimen collection data, and attitudes about virtual biorepositories. Respondents were primarily principal investigators at PhD granting institutions (91.1%) conducting basic (62.3%) research; most were non-Hispanic White (63.4%) and men (60.6%). The low response rate limited the statistical power of the analyses, further the number of respondents for each survey question was variable.ResultsFindings from this study identified barriers to biospecimen research, including lack of access to sufficient biospecimens, and limited availability of diverse tissue samples. Many of these barriers can be attributed to poor annotation of biospecimens, and researchers’ unwillingness to share existing collections. Addressing these barriers to accessing biospecimens is essential to combating cancer in general and cancer health disparities in particular. This study confirmed researchers’ willingness to participate in a virtual biorepository (n = 50 respondents agreed). However, researchers in this region listed clear specifications for establishing and using such a biorepository: specifications related to standardized procedures, funding, and protections of human subjects and intellectual property. The results help guide strategies to increase data sharing behaviors and to increase participation of researchers with multiethnic biospecimen collections in collaborative research endeavorsConclusionsData sharing by researchers is essential to leveraging knowledge and resources needed for the advancement of research on cancer health disparities. Although U.S. funding entities have guidelines for data and resource sharing, future efforts should address researcher preferences in order to promote collaboration to address cancer health disparities.

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IRB practices and policies regarding the secondary research use of biospecimens

Cited by 23 publications

References 17 publications

Consenting for Current Genetic Research: Views of Canadian Institutional Review Board Members

Consenting for Current Genetic Research: Views of Canadian Institutional Review Board Members

Comparing human and mouse salivary glands: A practice guide for salivary researchers

To Share or Not to Share? A Survey of Biomedical Researchers in the U.S. Southwest, an Ethnically Diverse Region

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