Biospecimen Research Research Articles

What Has the Sudden Unexpected Infant Death and Sudden Death in the Young Case Registry Learned About Consenting Families for DNA Banking and/or Genomic Research?

Since 2015, the Sudden Unexpected Infant Death (SUID) and Sudden Death in the Young (SDY) Case Registry has characterized sudden and unexpected deaths among young people (0-20 years). Families may provide informed consent to save biospecimens for banking and/or genomic research. We reviewed all consent-eligible cases to describe the frequency, time from death to consent, type (paper, phone, or electronic), and staffing method (Medical Examiner Office-based bereavement counselor vs outsourced genetic counselor). Of 5438 cases from January 2015 to January 2022, 3498 (64%) were eligible for consent and 391 (11%) were successfully consented. Half (54%) were obtained within 60 days of the death, 39% within 48 hours. Most were paper based (73%); 23% were obtained by phone, and 4% electronically. Consent rates varied by site from 3% to 66%. Higher consent rates were achieved within a Medical Examiner Office by a social worker or death investigator. Only 3% of consents attempted by a contracted genetic counselor were successful. Identified barriers include lack of available contact information, inability to reach family using the collected information, and lack of response when contacted. Consent rates were highest shortly after death when families were contacted by the Medical Examiner Office as part of bereavement outreach.

Abstract B101: Knowledge, attitudes, and self-efficacy toward cancer genetic testing among Black women with and without breast cancer

Abstract Germline genetic testing for cancer risk offers opportunities for decision-making about screening and clinical risk management for individuals and their family members. Despite increasing availability of cancer genetic testing, Black individuals are still much less likely to receive or engage with testing compared to non-Hispanic white individuals. We sought to identify individual level factors influencing knowledge about and attitudes toward cancer genetic testing among Black women with and without breast cancer. Participants included 925 women from the Black Women’s Health Study who had previously provided a biospecimen for research and were invited to have their cancer genetic research findings confirmed via a CLIA-certified laboratory and learn their results as part of a randomized controlled trial. Prior to confirmation testing, all women completed a baseline questionnaire about personal and family history of cancer; prior genetic testing for hereditary cancer; and knowledge, attitudes, and confidence in one’s ability to use genetic information (genetics self-efficacy). We used linear regression to evaluate individual-level factors influencing cancer genetics knowledge, attitudes, and self-efficacy. Overall, mean knowledge score was 12.3 out of 16 (SD, 2.5); there were no differences in knowledge score between women who had a personal history of breast cancer and those who did not. While the majority of women answered most questions correctly, 20-30% of women were unable to correctly answer questions about validity of test results, clinical implications of a variant of uncertain significance, and legal protections against health insurance discrimination. Younger age, higher educational attainment, being married, and having had prior genetic testing were statistically significant predictors of higher total knowledge score. There were no differences in mean knowledge scores by first degree family history of breast cancer or personal history of breast or other cancer. Predictors of favorable attitudes and genetics self-efficacy included younger age, higher educational attainment, and being married. Women with a personal history of breast cancer had somewhat more favorable attitudes toward genetic testing compared to those with no prior history of breast cancer. In multivariable adjusted models, higher total knowledge was associated with more favorable attitudes and higher self-efficacy. In this cohort of highly educated Black women, overall cancer genetics knowledge was relatively high; however, evaluation of individual knowledge questions revealed opportunities for improvement in specific areas. Older women, those with lower educational attainment, and women who are not married or living as married may benefit from more targeted education about genetic cancer testing. Further, despite the role genetic testing currently plays in guiding cancer treatment, Black women who had breast cancer did not have higher knowledge scores than those without breast cancer and therefore may also benefit from targeted education. Citation Format: Kimberly A. Bertrand, Michelle Trevino-Talbot, Maggie Rudderman, Maureen Flynn, Howard J. Cabral, Julie R. Palmer, Catharine Wang. Knowledge, attitudes, and self-efficacy toward cancer genetic testing among Black women with and without breast cancer [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B101.

Assessing Views on Using Surplus Human Bio Specimens for Future Research among Pharmaceutical Sponsors: A Prospective Interventional Study

Assessing Views on Using Surplus Human Bio Specimens for Future Research among Pharmaceutical Sponsors: A Prospective Interventional Study

Biospecimen research and the law.

In the well-known case of Henrietta Lacks, cells from her tumor were taken without consent and used more than 70 years ago to create the first immortal human cell line ("HeLa" cells). That event led to many scientific breakthroughs and to the debate about the ethics of consent and requirements for compensation. May 2024 saw two decisions by US federal courts-one related to Lacks-that could narrow the scope of research allowed on tissues obtained without consent and on nonidentified tissues, with implications for biomedicine.

Enhancing participant understanding and ethical considerations in clinical trial biospecimen research: Insights from an oncology setting in India

This study explores the KAP of clinical trial participants on the use of surplus biospecimens for future research in Indian oncology trials. A hospital-based prospective study was conducted among 112 oncology clinical trial participants. Non-probability purposive sampling technique was used to recruit the participants. This study captured their socio-demographic information and pre and post-KAP assessment by using self-administered questionnaires and its highlights ethical concerns and the lack of global guidelines. The main goal is to understand participants’ understanding and opinions on sample collection, utilization, and storage, as well as the ethical implications. SPSS software used for statistical analysis to evaluate pre and post-intervention KAP scores using frequency, percentage, mean difference, standard deviation, and applied paired t-test and Wilcoxon signed ranks test to assess Different KAP Levels. The study analyzed knowledge, attitude, and practice levels among oncology clinical trial participants using statistical tests. Pre-test to post-test comparisons showed significant increases in knowledge (p < 0.001, Wilcoxon Signed Ranks Test), attitude (p < 0.001, paired-samples t-test), and practice (p < 0.001), highlighting the intervention’s effectiveness. This study highlights the effectiveness of interventions in improving the knowledge, attitude, and practice (KAP) of oncology clinical trial participants in India regarding the use of surplus biospecimens, emphasizing the importance of standardized guidelines in global oncology trials.

Evaluating the impact of translational research enrollment on the patient care experience of Veterans with prostate cancer who receive care through the Veterans Affairs (VA) healthcare system.

e23210 Background: Veterans with cancer represent a unique subset of patients with distinct exposure histories and cancer epidemiology. Translational research studies that incorporate Veteran-derived biospecimens are therefore critical to advance our understanding of Veteran cancer biology and improve treatment options for Veterans with cancer. Biospecimen-based translational studies also offer an opportunity to enhance the Veteran care experience by enabling Veterans to directly contribute to cancer research efforts. While the biologic benefits of biospecimen research have been well established, the benefit of translational research on the Veteran care experience has yet to be defined. In this study, we evaluated: 1. Whether Veteran enrollment in a biospecimen-based prostate cancer research study improved their VA patient care experience and satisfaction and 2. Whether a VA-based data analyst tool could be used to optimize patient enrollment in translational research studies. Methods: Beginning in January, 2022, Veterans with a diagnosis of prostate cancer receiving care at the William S. Middleton VA were enrolled in a translational research study that collected blood and tissue biospecimens for subsequent investigation and analysis. After at least 30 days of enrollment, subjects were sent an anonymous survey inquiring about how participation in the translational research study impacted their VA care experience and healthcare satisfaction. To optimize enrollment in the study, an ICD-9 code search function was employed within the medical record database to readily identify eligible VA clinic patients based on an active prostate cancer diagnosis. Descriptive analyses were performed using Prism statistical software. Results: Nearly all Veterans who responded to the questionnaire agreed that participation in translational research was a meaningful experience that increased their satisfaction with their VA medical care. In addition, a vast majority of Veterans surveyed felt that their research participation could help improve care for other Veterans, and most expressed willingness to participate in future VA research opportunities. In a secondary analysis, our ICD-9 search function accurately identified eligible VA clinic patients with a prostate cancer diagnosis, and implementation of this tool has saved approximately 30 minutes of weekly physician and research coordinator work compared to manual chart review. Conclusions: Veteran enrollment in translational research studies provides a meaningful experience for Veterans that can lead to increased satisfaction with the VA healthcare system. Future VA initiatives to improve the Veteran care experience should focus on expanding translational research opportunities for Veterans as well as addressing potential barriers to enrollment.

Do biobanks need pharmacists? Support of pharmacy students to biobanking of human biological material for pharmaceutical research and development.

This study aimed to assess the biobank awareness among Polish pharmacy students and how it affects their support for biobank research. A survey among 366 pharmacy students enrolled at two Polish medical universities: the Poznań University of Medical Sciences and Medical University of Lublin was conducted. Although most pharmacy students felt positivity about biobanking and expressed the willingness to donate their biospecimens for biomedical research, their awareness on research biobanks was low. Their willingness to participate was driven by the desire to benefit society, help advance science and develop new therapies. While students supported donation for most types of research, biobanks run by medical universities were the highest trusted research institutions. The primary factors associated with student's willingness to participate were religiosity and place of study. Notably, nonreligious students and those studying in Poznan exhibited more favourable attitudes toward donating for research and expressed greater support for the establishment of research biobanks in Poland. Since biobank awareness among future pharmacists is inadequate incorporating biobank competency domains into education and training of pharmacists is required.

"Lord Knows What's Being Done with My Blood!": Black Women's Perceptions of Biospecimen Donation for Clinical Research in the United States.

Black women are underrepresented in clinical research and clinical trials. Knowledge gaps lead to biased clinical practice and care. There is a small but growing body of literature on Black women's perceptions about participation when biospecimen donation is sought by researchers. This is the first known study to investigate willingness to participate in clinical research involving biospecimen donation among Black women of reproductive age in the United States. This cross-sectional study recruited 496 Black women (ages 18-49) from a research crowdsourcing platform. Participants completed a 46-item online survey which asked about their willingness to provide blood samples for clinical health research and reasons for their willingness or for any unwillingness. Descriptive statistics and thematic analysis method were used to analyze the data. Less than half (44%) of participants reported willingness to provide blood samples for clinical research. The most common concerns of those expressing unwillingness to provide samples were "fear of blood sample being misused" and "distrust with the health researchers handling the samples." We identified six qualitative themes from the analysis of participants' open-ended responses. The most important factors include a desire for integrity and transparency in research, institutional racism contributing to mistrust, and adequate compensation and clearly defined benefits to participation. The recruitment and engagement of Black women in clinical biospecimen research should involve transparent, trustworthy, and anti-racist practices and informed respect for Black women's autonomy. There is a need to address Black women's concerns about exploitative profits and mistrust of academic and medical institutions.

Abstract PO4-16-09: Enhancing Research on Inflammatory Breast Cancer through Count Me In: Assessing the Accuracy of Self-Reported Diagnoses

Abstract Background: Inflammatory breast cancer (IBC) is a rare and aggressive form of breast cancer that relies on clinical identification of specific breast changes for diagnosis, in addition to pathological confirmation of invasive breast cancer. There is a clear need to increase participation of patients with IBC in research to better understand its clinical course and optimal treatment strategy. Count Me In (CMI) is a nonprofit research initiative that enables patients across the United States and Canada to accelerate cancer research by sharing their clinical data and biospecimens. The Metastatic Breast Cancer Project (MBCProject) was the first CMI initiative and is a prospective longitudinal cohort designed to capture these data from patients with metastatic breast cancer. Methods: We reviewed available medical records of patients participating in the MBCProject and who self-reported as having IBC. Records were reviewed by a study team member to identify documentation by a provider of an IBC diagnosis. For records without a documented IBC diagnosis, the clinical symptoms were assessed using a novel quantitative IBC scoring system (Mason G et al. BCRF 2022) currently being validated. Finally, records were also assessed by a physician for final determination of an IBC diagnosis. Records were classified as “concordant” or “not concordant”. Concordant is defined as “review of medical records confirms IBC using the unifying set of specific diagnostic criteria”. We desired the rate of concordant cases to be ≥90%; if ≤ 85% it would be considered as unacceptable to rely solely on patient self-report of IBC diagnosis in future research. Results: We reviewed records of 79 patients participating in the MBCProject who self-identified as having IBC and had medical records collected. Of these, 51 (64.5%) had IBC stated in providers’ notes. Of the remaining 28 patients, 6/28 met criteria for IBC using the new IBC diagnostic criteria, 17/28 didn’t have evidence of IBC based on the records available and 6/28 we were unable to make a final determination due to lack of records at the time of initial diagnosis. In total, 57/79 (72%; 95% CI 61-82%) patients had a concordant diagnosis. Conclusion: Patient self-report registries such as CMI are invaluable for the collection of clinical information and biospecimens for research of patients with rare diseases, however, a self-reported diagnosis of IBC may not be reliable. To improve the accurate identification of IBC, optimization of the questions asked to patients on these registries is warranted. This may include additional screening questions such as specific skin findings and timing of onset of symptoms. Focusing on patients with stage III IBC may also provide a better patient population to test this strategy. Citation Format: Elizabeth Troll, Sean Ryan, Virginia (Ginny) Mason, Mariesa D. Powell, Aditi Hazra, Nikhil Wagle, Mary McGillicuddy, Sara Tolaney, Meredith Regan, Filipa Lynce. Enhancing Research on Inflammatory Breast Cancer through Count Me In: Assessing the Accuracy of Self-Reported Diagnoses [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-16-09.

Scoping Review of Barriers and Facilitators to Recruitment of Black People With Cancer in Biospecimen-Based Research.

The increasing focus on precision medicine to optimize cancer treatments and improve cancer outcomes is an opportunity to consider equitable engagement of people racialized as Black or African American (B/AA) in biospecimen-based cancer research. B/AA people have the highest cancer incidence and mortality rates compared with all other racial and ethnic groups in the United States, yet are under-represented in biospecimen-based research. A narrative scoping review was conducted to understand the current literature on barriers, facilitators, and evidence-based strategies associated with the engagement of B/AA people with cancer in biospecimen research. Three comprehensive searches of MEDLINE, CINAHL, Embase, and Scopus were conducted. Of 770 studies generated by the search, 10 met all inclusion criteria for this review. The most frequently reported barriers to engagement of B/AA people in biospecimen research were lack of biospecimen research awareness, fear of medical harm, and violation of personal health information privacy, resource constraints, and medical mistrust. Key facilitators included previous exposure to research, knowledge about underlying genetic causes of cancer, and altruism. Recommended strategies to increase participation of B/AA people in biospecimen-based research included community engagement, transparent communication, workforce diversity, education and training, and research participant incentives. Inclusion of B/AA people in biospecimen-based research has the potential to advance the promise of precision oncology for all patients and reduce racial disparities in cancer outcomes.

Attitudes of oncology patients’ towards biospecimen donation for biobank research

BackgroundSince the biological material that remains after diagnostic and therapeutic procedures plays crucial role in biobank research, this study aims to explore cancer patients’ views on the donation of biospecimens for research purposes.Methods548 oncology patients from two hospitals with oncology treatment units in Poznan, Poland, completed an anonymous, self-administered pen-and-paper questionnaire.ResultsAlthough only 43.4% of patients had heard of biobanks, 93.1% declared themselves willing to donate. 71.1% of patients believed that doctors should ask patients to donate, and 60.9% that this should be done before the medical procedure. While 65% of patients were willing to donate any type of tissue that remained after a medical procedure, blood, saliva and hair were indicated most frequently. 40.5% of patients would donate their entire body after death and 21% would refuse. Patients’ support for biobanks was mainly driven by the desire to support science, help advance cancer research and altruism. Some respondents expected health information or medical treatment. The most common barriers for donation were physical distance, repeated examinations, concerns over the privacy and confidentiality of data and the commercial or unethical use of samples. Patients’ attitudes toward biobank donation seemed to be associated with age, education level, declared religiousness, a family history of genetically determined diseases and whether they were a blood donor.ConclusionsAlthough cancer patients’ lack of biobank awareness had no effect on their affirmative attitudes towards biobank research, there is a need to further increase patients’ support and overcome possible barriers that might hinder their willingness to donate.

Abstract 1300: A collaborative approach to enhance tissue donation for cancer research; the UNC Patients and Researchers Together (PART) Program

Abstract Introduction: Tumor tissue-based cancer research is essential to translate scientific discoveries to improve treatments for cancer. Tissue donation programs require a partnership: patients donating tissue and researchers using tissue for translational research. Lineberger Comprehensive Cancer Center (LCCC) has established a program called Patients and Researchers Together (PART) to value and increase the number of patients who agree to donate tissue for research. The PART Program is a patient-centered partnership between patients, community members, oncologists, surgeons, researchers, as well as staff and faculty from the clinical trials office, tissue procurement facility and UNC health communications to increase tissue donations for cancer research by valuing the patient’s contribution. Methods: The PART program began in 2021 by convening a group of diverse partners with a common goal of valuing patients as partners in biospecimen research. Creating an environment of bidirectional communication and exchange of ideas to 1) inform patients about the benefits of donating tissue for research, 2) inform the public about the importance of tissue to help researchers learn more about cancer, and 3) ensure researchers at UNC have access to tissue for their research. In the initial phase, the PART team evaluated the tissue research needs at LCCC by conducting surveys, interviews and focus groups with key partners. This set the foundation for the focus of current activities. One of the key focus areas is to communicate to patients and the public about the value of using tissue in research. The PART program established a working group to develop patient materials. The working group developed a template for educational materials, study summaries and a rigorous review process. The development of materials and iterative review process includes content experts, health literacy experts, patients and community members, and communications experts. Results: The PART working group developed a series of educational materials about tissue donation for research. Understanding the importance of donating tissue for research is the first step in engaging with patients. The team developed a template and a multi-step process to review documents. PART used this information to develop a website to promote tissue donation for research to the public. The team has been developing summaries of studies focused on tissue donation. We developed or consulted on 2 general education flyers and 8 study summaries in a variety of cancer types. There is a continuous queue of studies in progress and plans to develop more general education materials. PART patients and community members are leading the effort to educate patients and the public about tissue use in research. LCCC values patients who donate their tissue to research to improve the lives of all cancer patients. Citation Format: Patricia A. Spears, Missy Van Lokeren, Vernal Branch, Jennifer A. Potter, Ryan Robinson, Patient And Researchers Together (PART) Team. A collaborative approach to enhance tissue donation for cancer research; the UNC Patients and Researchers Together (PART) Program [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1300.

Abstract 1292: ProTALKS: A community outreach project founded by a graduate of the CaRE2 Community Scientist Research Advocacy training program, Mrs. Lynn Jones-Turpin

Abstract ProTALKS was created and led by a community member committed to reducing prostate cancer health disparities. ProTALKS stands for Prostate Cancer Outreach, Opinions, and Opportunities and is designed to increase awareness of prostate cancer prevention, research, and treatment as well as highlight the health disparities observed in Black communities. According to the Florida Department of Health, prostate cancer incidence and mortality rates among Black men living in Duval County are higher compared to men of other races and ethnicities. Therefore, there is a need for programs like ProTALKS that focus on early detection strategies and promoting community resources. In collaboration with the Prostate Health Education Network (PHEN), The American Legion Post 197, and Florida Blue, ProTALKS has increased access to services such as prostate cancer screening and evidence-based information. Community events implemented by ProTALKS bring together oncologists, researchers, key community leaders, health educators, and providers to educate and promote positive health behavior changes among high-risk communities. In addition to hosting health fairs, ProTalks has hosted grilling competitions and community awareness walks to further educate the community about prostate cancer prevention, screening, and research. ProTALKS also shares information through the local newspaper, The Jacksonville Free Press, The Lynn & Friends radio show, and social media platforms. Since its start in 2021, with support from the Florida-California Cancer Research, Education, and Engagement (CaRE2) Health Equity Center, ProTALKS has implemented more than 10 community events with over 1,000 community members from Jacksonville, Florida. ProTALKS, in collaboration with CaRE2, continues to disseminate information about cancer screening, the importance of clinical trial participation, and donating biospecimens for cancer research. Although ProTALKS has been successful in its mission, there have been challenges throughout its implementation. For example, one challenge has been increasing the number of community members attending events and using appropriate marketing techniques to promote ProTALKS’ activities. Future implications to avoid challenges include recruiting more volunteers, and partnering with other community organizations in Duval County. Citation Format: Lynn Jones-Turpin, Ileana Guzman, Brooke Hensel, Fern Webb. ProTALKS: A community outreach project founded by a graduate of the CaRE2 Community Scientist Research Advocacy training program, Mrs. Lynn Jones-Turpin [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1292.

The ethics of clinical research in the era of COVID-19.

There is an urgent need for increased understanding of COVID-19 and strategies for its prevention, treatment, and mitigation. All participants in the research enterprise, including institutional review boards, have an ethical duty to protect participants and ensure that the benefits gained from such research do not conflict with the core principles that guided researchers prior to the pandemic. In this review, we discuss the ethical issues surrounding initiation and conduct of clinical trials, focusing on novel COVID-19 therapeutic, vaccine, or biospecimen research, using the principles of autonomy, beneficence, and justice. We discuss strategies to manage the practical challenges associated with the conduct of clinical trials, with an emphasis on maintaining the rights and welfare of research participants.

Applying Findable, Accessible, Interoperable, and Reusable Principles to Biospecimens and Biobanks.

The importance of stimulating greater sharing of data for use and reuse in health research is widely recognized. To this end, the findable, accessible, interoperable, and reusable (FAIR) principles for data have been developed and widely accepted in the research community. Research biospecimens are a resource that leads to much of this health research data but are also a form of data. Therefore, the FAIR principles should apply to biospecimens. Nevertheless, there is a widespread problem of not sharing biospecimen resources that is clearly visible within the research arena. The impacts of this are likely to include diversion of precious research funds into compiling duplicate biospecimen cohorts, detraction from research productivity as researchers compete for and create duplicate resources, and deterrence of attempts to assess research reproducibility. This article explores some of the barriers that may limit availability of FAIR biospecimens. These barriers relate to the type of biospecimen collections and the characteristics of the custodians that influence their intention and interest in sharing. Barriers also relate to the ethical, legal, and social issues concerning collections, the research context of the collections, and cost and expertise involved in repurposing collections to enable sharing. Several solutions to increase sharing are identified. Some have recently been implemented, including enhancing biospecimen locators with tools to guide researchers and facilitating transfer of research collections to centralized biobank infrastructures at the conclusion of projects. New proposed solutions include improving search capabilities within publication databases, and introduction of evidence-based justifications for all new collections into peer-reviewed grant competition processes. It is recognized that there are both scientific factors and practical reasons that can impose limits to sharing biospecimens. However, funding availability, productivity, and progress in health research all stand to benefit from improved sharing of research biospecimen collections.

Public and Patients' Perspectives Towards Data and Sample Sharing for Research: An Overview of Empirical Findings.

We aimed to review the attitudes and perspectives of the public and patients towards the sharing of data and biospecimens for research and to identify common dimensions, regardless of setting. Our review included systematic, scoping or thematic reviews of empirical studies retrieved from Medline (PubMed interface), Web of Science, Scopus, ProQuest and Cochrane Reviews. The main themes identified and synthesised across the 14 reviews were readiness and motivations; potential risks and safeguards; trust, transparency and accountability; autonomy and preferred type of consent; and factors influencing data and biospecimen sharing and consent. Sociodemographic factors and research and individual context remain relevant influencing factors in all settings, while preferences for types of consent are highly heterogeneous. Trusted environments and adapted consent options with participant engagement are relevant to improve research participation.

Building blocks for better biorepositories in Africa

BackgroundBiorepositories archive and distribute well-characterized biospecimens for research to support the development of medical diagnostics and therapeutics. Knowledge of biobanking and associated practices is incomplete in low- and middle-income countries where disease burden is disproportionately high. In 2011, the African Society of Human Genetics (AfSHG), the National Institutes of Health (NIH), and the Wellcome Trust founded the Human Heredity and Health in Africa (H3Africa) consortium to promote genomic research in Africa and established a network of three biorepositories regionally located in East, West, and Southern Africa to support biomedical research. This manuscript describes the processes established by H3Africa biorepositories to prepare research sites to collect high-quality biospecimens for deposit at H3Africa biorepositories.MethodsThe biorepositories harmonized practices between the biorepositories and the research sites. The biorepositories developed guidelines to establish best practices and define biospecimen requirements; standard operating procedures (SOPs) for common processes such as biospecimen collection, processing, storage, transportation, and documentation as references; requirements for minimal associated datasets and formats; and a template material transfer agreements (MTA) to govern biospecimen exchange. The biorepositories also trained and mentored collection sites in relevant biobanking processes and procedures and verified biospecimen deposit processes. Throughout these procedures, the biorepositories followed ethical and legal requirements.ResultsThe 20 research projects deposited 107,982 biospecimens (76% DNA, 81,067), in accordance with the ethical and legal requirements and established best practices. The biorepositories developed and customized resources and human capacity building to support the projects. [The biorepositories developed 34 guidelines, SOPs, and documents; trained 176 clinicians and scientists in over 30 topics; sensitized ethical bodies; established MTAs and reviewed consent forms for all projects; attained import permits; and evaluated pilot exercises and provided feedback.ConclusionsBiobanking in low- and middle-income countries by local skilled staff is critical to advance biobanking and genomic research and requires human capacity and resources for global partnerships. Biorepositories can help build human capacity and resources to support biobanking by partnering with researchers. Partnerships can be structured and customized to incorporate document development, ethics, training, mentorship, and pilots to prepare sites to collect, process, store, and transport biospecimens of high quality for future research.

Biospecimen Qualification in a Clinical Biobank of Urological Diseases.

Development of novel biomarkers for diagnosis of disease and assessment of treatment efficacy utilizes a wide range of biospecimens for discovery research. The fitness of biospecimens for the purpose of biomarker development depends on the clinical characteristics of the donor and on a number of critical and potentially uncontrolled pre-analytical variables. Pre-analytical factors influence the reliability of the biomarkers to be analyzed and can seriously impact analytic outcomes. Sample quality stratification assays and tools can be utilized by biorepositories to minimize bias resulting from samples' inconsistent quality. In this study, we evaluated the quality of biobanked specimens by comparing analytical outcomes at 1, 5, and 10 years after collection. Our results demonstrate that currently available assays and tools can be used by biobank laboratories to support objective biospecimen qualification. We have established a workflow to monitor the quality of different types of biospecimens and, in this study, present the results of a qualification exercise applied to fluid samples and their derivatives in the context of urological diseases.

When Biobanks Meet Religion: Association Between Religiosity and Attitudes of Polish Medical Students Toward Biobanking of Human Biological Material for Research Purposes

While biobanking is expanding globally, the empirical evidence concerning the impact of religion on future healthcare professionals’ awareness and willingness to donate biospecimens for biobank research is lacking. To understand how medical students’ religious beliefs can fuel their questions regarding how biospecimens would be stored, cared for, and used, we conducted a survey among 1500 medical students at Poznań University of Medical Sciences. Our findings suggest that, while both religious and nonreligious students supported the idea of biobanking of human biological material and were willing to donate for research purposes, nonreligious students felt more positive toward biobanking, supported the idea of establishing biobanks in Poland more often, and were more eager to donate most types of tissues and to participate in biobank research. Religious beliefs were also associated with medical students’ perception of benefits and risks resulting from biobanking, perceived trust toward various biobank institutions, and preferred type of consent.

Sustained agreement rates in the longitudinal assessment of lupus patients to a Broad Consent for personal data and specimen usage in the RHINEVIT biobank.

Biobanks are essential structures for scientific research. The RHINEVIT biobank is used to recruit biomaterials from rheumatology patients in outpatient care and to conduct clinical research studies (e.g., cohort studies) and basic research. RHINEVIT established Broad Consents (BC) to allow extensive and relevant usage of data and biospecimens without the need for specific project restrictions. For quality assurance, we compared the consent rate of individual items of the BC versions in patients with systemic lupus erythematosus (SLE) in the longitudinal study. BCs were used for biomaterial donation. Informed consent data from RHINEVIT were analyzed. Due to the content restructuring of the BC items due to changes from the templates of the working group of the Medical Ethics Commissions in the Federal Republic of Germany and GDPR requirements, content mapping of the items was performed for the analysis. From September 2015 to March 2022, 291 SLE outpatients donated biomaterials. In 119 patients, the BC was renewed at least once in a subsequent biomaterial donation. Three biomaterial donations were obtained from 21 patients and four from six patients using the respective BC. However, one consent was later revoked. Consent to the BC topics showed consistently high rates of agreement (range 97.5%-100%), with only some patients disagreeing with individual topics. This remained stable over time (median 526 days [Q1 400, Q3 844]). None of the patients disagreed with a certain topic in two consecutive visits. Modifications to the BC did not result in any relevant changes in the approval rates for SLE patients. RHINEVIT's BC is successfully used for the quality-assured handling of excellently annotated biomaterial. The long-term use of these highly valuable biospecimens for unrestricted research, also in an international context, remains assured.