The Views of Participants in DNA Biobanks
|
|
- Clyde Shepherd
- 6 years ago
- Views:
Transcription
1 The Views of Participants in DNA Biobanks Kelly E. Ormond, I Maureen E. Smith, II & Wendy A. Wolf III Abstract Biobanks are generally created with the long-term goal of establishing genotype-phenotype correlations. These resources collect and link DNA with health information for use in future genetic research studies. The biobanking process can vary with regard to specific characteristics in study design. Biobanks may extract DNA by using DNA from leftover samples or obtaining new DNA samples specifically for the biobank. Biobanks also vary in whether they use an optin or opt-out informed consent process. Some biobanks collect health information at a single point in time, while others re-access such information at designated points in the future to categorize subjects accurately into affected/unaffected status. These study design differences can influence the perception of participants and affect their willingness to participate. This paper will address the following three key issues: (1) why people decide to participate in DNA biobanks, (2) what enrollees understand about their participation in DNA biobanks, and (3) how participants feel about the possibility that biobanks will re-contact them, either to obtain new information for future studies or to share potential study results. Finally, we will suggest how information related to these three key issues ought to inform future study design for biobanks. I. INTRODUCTION...81 II. WHY DO PEOPLE DECIDE TO PARTICIPATE IN DNA BIOBANKS?...82 III. WHAT DO ENROLLEES UNDERSTAND ABOUT THEIR PARTICIPATION IN A DNA BIOBANK?...83 IV. HOW DO PARTICIPANTS FEEL ABOUT BIOBANK RE-CONTACT, AND HOW SHOULD THIS INFORMATION INFORM STUDY DESIGN?...84 V. CONCLUSION...87 I Stanford University, Department of Genetics, Stanford, CA. II Northwestern University, Center for Genetic Medicine, Chicago, IL. III Northwestern University, Center for Genetic Medicine, Chicago, IL.
2 81 STANFORD JOURNAL OF LAW, SCIENCE & POLICY Vol. 1 I. INTRODUCTION DNA biobanks are created with the long-term goal of establishing genotype-phenotype correlations through collecting and linking DNA with health information. Researchers can use these correlations in research studies that are typically not yet conceived when the biobanks are created. These biobanks may utilize the stored DNA for discovery research, which may include targeted genomic tests, genome-wide association studies, 1 and potentially whole genome sequencing studies in the future. The ethical issues that surround DNA biobanks depend largely on the study design and methods utilized by each biobank, and it is therefore important to understand the variety of ways that biobanks can differ in study design and methods. First, biobanks may extract DNA from leftover clinical samples 2 or obtain new samples specifically intended for usage in a specific biobank. 3 Second, biobanks may use different subject recruitment processes; biobanks can be population-based, narrowly focused on specific medical conditions with a control population, or broadly focused on a range of disorders varying in frequency, treatability, severity and social stigma. 4 The subject recruitment process may either request subjects to opt in (so that a potential subject makes an active decision to participate subsequent to an informed consent process), or to opt out (so that a potential subject is assumed to enroll unless the subject actively declines). The opt out option is characteristic of a presumed consent model, where participants are presumed to enroll in biobanks after obtaining healthcare in certain settings. 5 Finally, the last study method where biobanks differ is in their timing for collecting health information; they may collect health information at a single point in time or may re-access such information at designated points in the future to categorize subjects accurately as affected or unaffected. Some biobanks choose to have re-contact options so that they can follow up with participants with results from past studies or with requests to obtain consent for future specific studies. 6 The health informatics required for these options may require varying levels of deidentification. Coded samples typically involve the efforts of biobank investigators to link the sample with a code rather than with personally identifiable information, such as a name or social security number. (However, investigators may maintain some links to participants in order to redeposit genomic information and to re-contact participants in the future). Researchers who 1 These studies may include, for example, the assessment of assessing low penetrance genes for common diseases or the search for modifier genes that impact phenotype. 2 See Dan Roden et al., Development of a Large-Scale De-Identified DNA Biobank to Enable Personalized Medicine, 84 CLINICAL PHARMACOLOGY AND THERAPEUTICS 362, 364, 367 (2008) (discussing how a majority of the samples was collected from leftover blood samples). 3 See Catherine A. McCarty et al., Marshfield Clinic Personalized Medicine Research Project (PMRP): Design, Methods and Recruitment for a Large Population-Based Biobank, 2 PERSONALIZED MED. 49, 52 (2005) (discussing how DNA was extracted from each patient). 4 See Lyle J. Palmer, UK Biobank: Bank on It, 369 THE LANCET 1980 (2007); Greta Lee Splansky et al., The Third Generation Cohort of the National Heart, Lung, and Blood Institute s Framingham Heart Study: Design, Recruitment, and Initial Examination, 165 AM. J. EPIDEMIOLOGY 1328 (2007). 5 See Melissa A. Austin et al., Genebanks: A Comparison of Eight Proposed International Genetic Databases, 6 COMMUNITY GENETICS 37, 39 (2003) (describing presumed consent and the opt-out option in Icelandic Health Center Database); Roden et al., supra note 2, at (describing the advantages and limits of opt-out study design). 6 Kelly E. Ormond et al., Assessing the Understanding of Biobank Participants, 149 AM. J. MED. GENETICS 188, (2009).
3 2010 THE VIEW OF PARTICIPANTS IN DNA BIOBANKS 82 utilize the samples typically receive only the coded samples and do not have access to the identification links. De-identified data sets include none of the eighteen HIPAA protected data points, while limited data sets may include either dates, geographic data, or both. Samples that have no link to identifiable information preclude biobanks from updating participants with results or re-contacting again to discover further health information. All of these different study methods influence the ethical issues related to biobank participation. This paper will focus on three key issues relevant to biobanks and their related ethical considerations: (1) why people decide to participate in DNA biobanks, (2) what enrollees understand about their participation in a DNA biobank, and (3) how participants feel about biobank re-contact, whether to give new information for future studies or to receive aggregate or individual study results. After addressing these concerns, we will conclude by proposing how information about these issues should inform study design for DNA biobanks. II. WHY DO PEOPLE DECIDE TO PARTICIPATE IN DNA BIOBANKS? Several studies have addressed the reasons why enrollees do or would participate in DNA biobanks 7 or other genetic research studies. 8 One important stated reason is altruism; 9 participants report that they feel good helping mankind or want to give back after facing illness in themselves or family members. Less frequently, participants express that they want to contribute to the general knowledge for science, medicine, and genetics, or that they want to assist researchers with building a database that will aid the discovery of specific disease genes or genotype/phenotype correlations and subsequent research on treatments or cures. Other factors that appear to influence participation in DNA biobanks include general interest in science, genetics, or research participation, trust in the sponsoring institution, 10 ease of participation (especially if no additional blood sample or time is required), and the perceived low risk of having a blood test. Finally, as will be discussed later in the paper, some participants report that they chose to participate because of the potential to gain personal or family benefits, such as improved testing or treatment. 11 Several studies suggest that a majority of potential enrollees are comfortable with the study concepts and purposes 12 and would consider participation in a DNA biobank. 13 With that said, actual enrollment in biobanks varies significantly based on each biobank s study design and 7 See Laura M. Beskow & Elizabeth Dean, Informed Consent for Biorepositories: Assessing Prospective Participants Understanding and Opinions, 17 CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION 1440 (2008); Catherine A. McCarty et al., Informed Consent and Subject Motivation to Participate in a Large, Population-Based Genomics Study: The Marshfield Clinic Personalized Medicine Research Project, 10 COMMUNITY GENETICS 2 (2007); Ormond et al., supra note 6, at See Donald J. Willison et al., Patient Consent Preferences for Research Uses of Information in Electronic Medical Records: Interview and Survey Data, 326 BRIT. MED. J. 373 (2003). 9 Ormond et al., supra note 6, at 191; Willison et al., supra note 8, at See Beskow, supra note 7, at 1442; Ormond et al., supra note 6, at See Beskow, supra note 7, at 1444; Ormond et al., supra note 6, at 193 tbl.2, 195; Mary Dixon-Woods et al., Beyond Misunderstanding : Written Information and Decisions About Taking Part in a Genetic Epidemiology Study, 65 SOC. SCI. MED. 2212, 2218 (2007). 12 Gill Haddow et al., Generation Scotland: Consulting Publics and Specialists at an Early Stage in a Genetic Database s Development, 18 CRITICAL PUB. HEALTH 139, 142 (2008); Informed Consent, supra note 7, at 6 7; Ormond et al., supra note 6, at 191, See Beskow, supra note 7, at 1440, 1447; Jill M. Pulley et al., Attitudes and Perceptions of Patients Towards Methods of Establishing a DNA Biobank, 9 CELL TISSUE BANKING 55, 58 (2008).
4 83 STANFORD JOURNAL OF LAW, SCIENCE & POLICY Vol. 1 recruitment practices. In one study, when the biobank used cold call recruitment by a study recruiter, 15% of the potential population chose to enroll. 14 In contrast, if a trusted care provider, such as a primary care physician or specialist physician, encourages enrollment, a much higher percentage of the potential population appears to enroll. 15 Projects that enlist already involved study populations to further participate in a biobank have greater success in gaining participation. 16 The extent of community involvement in the biobank design and governance may also have an effect on participation rates. 17 In projects where there is an opt out recruitment model, the decline rate may be less than 1 in 1600 and as high as 2 to 3%. 18 This suggests that in a setting where there is perceived approval from a trusted care provider (by inclusion on standard forms, for example) and low risk or inconvenience, most people are willing to consider enrolling in a DNA biobank. These varying rates of participation suggest that trust in the health care provider, investigator, or institution play a large role in biobank participation. 19 Also, offering future receipt of results or compensation has also been found to increase participation. 20 In countries outside the United States, legislation in support of establishing biobanks and providing datasharing protections has often preceded the onset of recruitment. 21 III. WHAT DO ENROLLEES UNDERSTAND ABOUT THEIR PARTICIPATION IN A DNA BIOBANK? There are a number of potential challenges to achieving informed consent for participants in biobanks. These challenges include how to describe the nature of the research (when researchers obtaining consent for future research may not yet know what may be done in the course of the future research); what to communicate to participants about the possible commercialization of the research through patents; and how to address the risks of potential discrimination and the related fears that participants may have about discrimination. Another potential challenge is how to decide what type of confidentiality protections to enforce. Greater privacy protection for participants would enable researchers to acquire more non-identifiable study data, but such data would preclude potential acquisition of longitudinal health information and the possibility of re-contacting participants. Last but not least, researchers must consider 14 Ormond et al., supra note 6, at 189. The authors learned about this information regarding cold call recruitment through Wendy Wolf s role as the director of the NUgene study at Northwestern University, a study that has not yet been published. 15 Ormond et al., supra note 6, at 189. The authors also learned about this information from Wolf s role as the director of the NUgene study. 16 Splansky et al., supra note 4, at 1331, See Béatrice Godard et al., Strategies for Consulting with the Community: The Cases of Four Large-scale Genetic Databases, 10 SCI. & ENGINEERING ETHICS 457, 457 (2004); Catherine McCarty et al., Community Consultation and Communication for a Population-Based DNA Biobank: The Marshfield Clinic Personalized Medicine Research Project, 146A AM. J. MED. GENET (2008). 18 Linus Johnsson et al., Patients Refusal to Consent to Storage and Use of Samples in Swedish Biobanks: Cross Sectional Study, 337 BRIT. MED. J. a345 (2008); Roden et al., supra note 2, at See Gail Henderson et al., Great Expectations: Views of Genetic Research Participants Regarding Current and Future Genetic Studies, 10 GENETICS IN MED. 193 (2008); Nancy E. Kass et al., Trust: The Fragile Foundation of Contemporary Biomedical Research, 26 THE HASTINGS CENTER REP. 25, (1996); Ormond et al., supra note 6, at 191, David Kaufman et al., Subjects Matter: A Survey of Public Opinions About a Large Genetic Cohort Study, 10 GENETICS IN MED. 831, 835 (2008). 21 Godard et al., supra note 17, at 462.
5 2010 THE VIEW OF PARTICIPANTS IN DNA BIOBANKS 84 how to communicate with participants about results from genetic research, when there may be great controversy about what those results actually imply. Each of these challenges are factors that may influence the overall enrollment and diversity of study population samples, as well as the ability of participants to comprehend the complex nature of biobanking and genomic research. Only a few studies have addressed the understanding of current DNA biobank participants. 22 These studies show that participants generally have a good understanding of the nature and purpose of the biobank, but have far less understanding of confidentiality and potential risks from participating in the study. More specifically, in both of these studies, most participants recognized confidentiality as an issue of potential concern, but they felt that they were at low or no risk for any breach of confidentiality, assuming that the study design and privacy protections were adequate. Few participants in either study specifically mentioned concerns regarding employer or insurance discrimination, and a percentage of those who did also discounted those concerns on the basis of age or prior illness. These studies were completed prior to full implementation of the data sharing standards for federally funded genome-wide association studies. 23 Further evaluation of participants concerns about privacy and use of genetic data will need to be assessed following implementation of this policy. In the next few years, it will also be important to assess whether potential biobank participants have concerns about the confidentiality of their genetic information, both as federal laws such as the Genetic Information Nondiscrimination Act of 2008 (GINA) are more fully enacted and as genetic testing for conditions that may be viewed as stigmatizing, such as psychiatric conditions and neurodegenerative conditions such as dementia, become more common. IV. HOW DO PARTICIPANTS FEEL ABOUT BIOBANK RE-CONTACT, AND HOW SHOULD THIS INFORMATION INFORM STUDY DESIGN? Various approaches to re-contact and re-consent include: (1) no option for re-contact or re-consent; (2) the ability for participants to opt out of specific types of future studies; (3) recontact if future studies need more information or meet certain IRB criteria; or (4) a requirement for re-contacting participants and obtaining new consents for any future study. With respect to the re-consent issue, most current literature suggests that only a small percentage of research participants withdraw their samples from future research studies. 24 Research also suggests that participants do not want to be re-contacted separately for all future studies 25 but are willing to be contacted to provide information for future studies. 26 Factors that suggest that participants would want to be re-contacted for future uses of their sample or data are whether the samples are clinically obtained or personally identifiable, and whether the samples were obtained for research 22 McCarty et al., supra note 7, at 2 7; Ormond et al., supra note 6, at The National Institutes of Health implemented the data sharing standards for federally funded genome-wide association studies. NAT L INSTS. OF HEALTH, NOT-OD , POLICY FOR SHARING OF DATA OBTAINED IN NIH SUPPORTED OR CONDUCTED GENOME-WIDE ASSOCIATION STUDIES (GWAS) (2008), available at 24 Johnsson et al., supra note 18; Birgitta Stegmayr & Kjell Asplund, Informed Consent for Genetic Research on Blood Stored for More than a Decade: a Population Based Study, 325 BRIT. MED. J. 634, (2002). 25 See Stegmayr & Asplund, supra note 24, at 634 (discussing how 22.3% of participants wanted to be informed about and give new consent for each new genetic project). 26 McCarty et al., supra note 3, at 55 ( Only 142 participants (0.81%) opted out on the consent form for contact for future studies. ); Ormond et al., supra note 6, at 190.
6 85 STANFORD JOURNAL OF LAW, SCIENCE & POLICY Vol. 1 on a specific disease rather than as part of a biobank. 27 In one further recent study, 85% of its interviewees stated that they would consent to having their DNA stored indefinitely for future research. 28 These studies suggest that if participants in a de-identified biobank are given appropriate information that a variety of genetic tests will be performed, it seems unlikely that re-consent for each individual study would be beneficial or desired by most participants. Questions of re-contact will only become more significant with the advent of technologies. Genome-wide association studies and whole genome sequencing may lead to unanticipated uses of samples and obligatory data-sharing, which may eventually identify specific disease risks for individuals, particularly for rare or unusual disorders. New technological advances also raise the question of re-contact for return of results, particularly when this was not in the original study design. 29 Regarding the potential disclosure of research results, there has been growing support in recent years for participant rights to research data, as well as a sense that researchers are obligated to disclose results out of respect for participants. 30 As some of these papers suggest, this raises two critical questions: (1) how does one define clinically relevant or significant findings?; and (2) how does one maintain records for re-contact in a manner that minimizes risks to confidentiality? Regarding the current literature on this topic, one key reference is a position paper by the National Bioethics Advisory Commission. 31 NBAC suggests that disclosure of genetic research results should occur only in exceptional circumstances and that the informed consent process should describe when and why such disclosure may occur and include a plan for management, appropriate referrals, and medical advice. NBAC also specifies that such results should be scientifically valid and confirmed, that the results should pose significant health concerns, and a course of action to ameliorate or treat these concerns is readily available. 32 While this may appear to be a straightforward guideline for researchers, our own experience suggests that more than ninety percent of patients will opt for potential re-contact with research results, 33 and that providing such an option can lead study participants to expect to receive such results in the future. 34 Two sample quotations from papers include: I believe I will [get results back] if there is any reason for me to. According to the consent form, it said that if there were anything that they learned as a result that affected some condition that they would pass that on to me See Stegmayr & Asplund, supra note 24; Dave Wendler & Ezekiel Emanuel, The Debate Over Research on Stored Biological Samples: What Do Sources Think?, 162 ARCHIVES OF INTERNAL MED. 1457, 1461 (2002). 28 See Beskow & Dean, supra note 7, at 1446 ( Most (85%) interviewees said that, if asked, they would allow their blood and information to be stored indefinitely at the Biorepository for use in future research ). 29 Susan M. Wolf et al., Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations, 36 J. OF LAW MED. & ETHICS 219, 239 (2008); See Timothy Caulfield et al., Research Ethics Recommendations for Whole-Genome Research: Consensus Statement, 6 PLOS BIOLOGY 430, 431 (2008). 30 Conrad V. Fernandez & Charles Weijer, Obligations in Offering to Disclose Genetic Research Results, 6 AM. J. BIOETHICS 44, (2006); Fiona A. Miller et al., Duty to Disclose What? Querying the Putative Obligation to Return Research Results to Participants, 34 J. MED. ETHICS 210, (2008); David Shalowitz & Franklin Miller, The Search for Clarity in Communicating Research Results to Study Participants, 34 J. MED. ETHICS (2008). 31 NAT L BIOETHICS ADVISORY COMMISSION, RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS: ETHICAL ISSUES AND POLICY GUIDANCE 1 (1999). 32 Id. at Ormond et al., supra note 6, at Beskow & Dean, supra note 7, at ; Dixon-Woods et al., supra note 11, at Ormond et al., supra note 6, at 195.
7 2010 THE VIEW OF PARTICIPANTS IN DNA BIOBANKS 86 I think [the statement that you should not expect to get individual results] is practical.... However, I would hope that if there were something wrong with me, and... there was an easy fix, that somehow there should be a way for that information to get back to my doctors. 36 This data suggests that individuals hypothetically desire clinical and genetic research results, but it is unclear whether they understand the potential implications of receiving such information. For example, several studies found that roughly sixty to ninety percent participants in genetic research hope to receive genetic test results for a real or hypothetical condition in them or in their families. 37 However, few participants provided any qualifiers; it is unclear whether a particular participant s desire for testing would change due to the age or family status of the participant, the type of disease being tested, or the treatability of the disease. Additionally, a number of studies addressing highly penetrant mendelian conditions have found that the hypothetical offering of results to at risk individuals is not a good predictor of what individuals will do once confronted with the actual opportunity to obtain results. The percentage of individuals who actually take predictive genetic tests is frequently much lower than the percentage of individuals who expressed initial interest in taking such tests. 38 This suggests that receiving results is appealing in theory, but in reality, individuals have varied opinions on the desirability of results. Two questions follow from this experience. The more important question, and the more difficult one to answer, is how to define clinically significant results. Concepts of clinical validity and clinical utility can be useful starting places, 39 but definitions of severity and treatability are highly subjective and may change over time for researchers, clinicians, and study participants. Fernandez and Weijer suggest that participants should be involved in determining whether they view a piece of information as clinically effective or of personal value. 40 Additionally, study design can critically impact any interpretation of what is clinically significant, particularly since most GWAS studies assess low penetrance/high frequency alleles; it may be many years before we understand in detail what prospective risks exist for persons carrying low penetrance/high frequency alleles individually or in combination. Whole genome sequencing studies, however, pose a different challenge, since such testing may detect rare but high penetrance conditions (such as BRCA, HNPCC, and Huntington s disease), as well as identify persons with autosomal recessive carrier status for a range of conditions. The second question is how researchers can optimally communicate with participants about the results of genetic testing. Genetic testing technologies provide researchers with both 36 Beskow & Dean, supra note 7, at 1445 tbl Ormond et al., supra note 6, at 195 (citing in addition other studies where several biobank participants hope to be re-contacted with results from genetic research); Wendler & Emanuel, supra note 27, at Christiane Bernhardt et al., Decreasing Uptake of Predictive Testing for Huntington's Disease in a German Centre: 12 Years' Experience ( ), 17 EUR. J. HUM. GENETICS 295, (2009); S. Creighton, et al., Predictive, Pre-natal and Diagnostic Genetic Testing for Huntington's Disease: The Experience in Canada from 1987 to 2000, 63 CLINICAL GENETICS 462, 462 (2003); Anneke Maat-Kievit et al., Paradox of a Better Test for Huntington's Disease, 69 J. NEUROLOGY, NEUROSURGERY & PSYCHIATRY 579, 579, 583 (2000). 39 Vardit Ravitsky & Benjamin Wilfond, Disclosing Individual Genetic Results to Research Participants, 6 AM. J. BIOETHICS 8, (2006); Centers of Disease Control & Prevention, Genomic Translation: ACCE Model Process for Evaluating Genetic Tests, (last visited Dec. 3, 2009). 40 Fernandez & Weijer, supra note 30, at 45.
8 87 STANFORD JOURNAL OF LAW, SCIENCE & POLICY Vol. 1 clinically useful information and information with no known clinical implications at the time of discovery. Researchers must consider how to communicate all that they know to participants, even when the predictive value of the genetic information is uncertain. In order for researchers to make the right disclosure decisions, deliberation over the return of genetic testing results should involve professionals with the appropriate clinical expertise to evaluate the results and to consider the medical and social impacts on recipients. 41 The genetics community, legal community, and general public should continue to discuss what results should be disclosed to patients and the appropriate thresholds at which disclosure should occur, particularly if a clinically validated test is publicly available. V. CONCLUSION Based on our experiences, we suggest that researchers and institutional review boards strongly consider the above points when designing DNA biobanks and subsequent studies. Issues to consider must include the subject recruitment process, informed consent process, and whether to provide or offer potential future results to participants. The involvement of various stakeholders, including the public, also substantially affects how each of these issues is handled in the design and governance of the biobank. Since our understanding of these issues is evolving quickly with the progress of genomics, it is reasonable to develop a plan for protocol evaluation and revisions. However, the recruitment and informed consent process must be structured in a way that will convey flexibility to participants without creating a false sense of expectation. 41 Caulfield et al., supra note 29, at 433.
Genomic Research: Issues to Consider. IRB Brown Bag August 28, 2014 Sharon Aufox, MS, LGC
Genomic Research: Issues to Consider IRB Brown Bag August 28, 2014 Sharon Aufox, MS, LGC Outline Key genomic terms and concepts Issues in genomic research Consent models Types of findings Returning results
More informationJeffrey R Botkin, MD, MPH Professor of Pediatrics Associate Vice President for Research
Jeffrey R Botkin, MD, MPH Professor of Pediatrics Associate Vice President for Research Disclosure of Research Results Hot issue at the present time due to whole genome sequencing and imaging in research
More informationReporting Results and Incidental Findings to Research Participants
Reporting Results and Incidental Findings to Research Participants Jeffrey R Botkin, MD, MPH Professor of Pediatrics Chief, Division of Medical Ethics and Humanities Associate Vice President for Research
More informationConsent Language Does Affect Your Ability to Share
Consent Language Does Affect Your Ability to Share Tuesday, February 13, 2018 Jean Barone HRPO Director Melissa Miklos HRPO Associate Director Change in Education Units Continuing Education Units will
More informationRegulatory and Ethical Issues in Repository Research
Regulatory and Ethical Issues in Repository Research Kelly Fryer-Edwards ITHS Bioethics Core and UW Bioethics Shannon Sewards Human Subjects Division Agenda Review of Regulatory and Ethical Issues Creating
More informationGenentech, Inc., its research partners, collaborators, assignees, licensees or designees. Invitation to Participate
CONSENT AND RESEARCH AUTHORIZATION TO DONATE BLOOD AND TISSUE SAMPLES FOR FUTURE RESEARCH PURPOSES YALE UNIVERSITY SCHOOL OF MEDICINE YALE-NEW HAVEN HOSPITAL 200 FR. 4 Study Title: An Open-Label, Phase
More informationIRB USE ONLY Approval Date: September 10, 2013 Expiration Date: September 10, 2014
Approval : September 10, 2013 Expiration : September 10, 2014 DESCRIPTION: You are invited to donate your excess sperm and/or testicular biopsy material, as well as your somatic cells (ordinary body cells
More informationEthical and Policy Issues in Biobanks
Ethical and Policy Issues in Biobanks Healthcare Innovation Privacy IAPP November 14 Chicago, IL Eric M. Meslin, Ph.D. Director, IU Center for Bioethics Professor of Bioethics Associate Dean (Bioethics)
More informationIRB USE ONLY Approval Date: September 10, 2013 Expiration Date: September 10, 2014
Approval : September 10, 2013 Expiration : September 10, 2014 DESCRIPTION: You are invited to donate your leftover frozen eggs and/or ovarian tissues generated during your fertility preservation treatment
More informationEthics of Precision Medicine in Low to Middle Income Countries
Ethics of Precision Medicine in Low to Middle Income Countries Sola Olopade, MD, MPH Professor of Medicine Director, International Programs Faculty, MacLean Center for Clinical Ethics University of Chicago
More informationIntegrating approaches to Privacy across the Research Lifestyle
Integrating approaches to Privacy across the Research Lifestyle Fall 2013 Workshop Tracking Consent Options at the Framingham Study Greta Lee Splansky Other Sources Of FHS Data (Each with policies, applications,
More informationISPE Comments on the CIOMS 2006 draft Special Ethical Considerations for Epidemiologic Research 1
Epidemiologic Research 1 December 12, 2006 Comments on 2006 CIOMS draft Special Ethical Considerations for Epidemiologic Research as proposed supplement to the updated 2002 CIOMS International Ethical
More informationGenetics/Genomics in Public Health. Role of Clinical and Biochemical Geneticists in Public Health
Genetics/Genomics in Public Health Role of Clinical and Biochemical Geneticists in Public Health Premises Human variation is vast Strength of genetic factors are a continuum from low to high Testing technology
More informationMeasuring Chemicals in People What Would You Say? A Boston Consensus Conference on Biomonitoring. December 11, 2006
Measuring Chemicals in People What Would You Say? A Boston Consensus Conference on Biomonitoring Consensus Statement December 11, 2006 Government by the people and for the people. We represent the general
More informationqcarrier Test INFORMATION DOCUMENT
qcarrier Test INFORMATION DOCUMENT The qcarrier Test is a laboratory test developed by qgenomics, aimed at studying your genetic material. It is based on a targeted analysis of human genome fragments,
More informationEthics and Values in Biotech
Ethics and Values in Biotech Thane Kreiner, Ph.D. Senior Vice President, Corporate Affairs Affymetrix The Promise of Genetics Public Perceptions 1971 1994 The Genome is Complex 3 B base pairs Only ~1.5%
More informationPHYSICIAN RESOURCES MAPPED TO GENOMICS COMPETENCIES AND GAPS IDENTIFIED WITH CURRENT EDUCATIONAL RESOURCES AVAILABLE 06/04/14
PHYSICIAN RESOURCES MAPPED TO GENOMICS COMPETENCIES AND GAPS IDENTIFIED WITH CURRENT EDUCATIONAL RESOURCES AVAILABLE 06/04/14 Submitted resources from physician organization representatives were mapped
More informationConsent Form. Protocol Title: Personal Genome Project
Consent Form Protocol Title: Personal Genome Project Principal Investigator: George M. Church, Ph.D. Site-Responsible Investigator's Institution: Harvard Medical School Co-Investigators & Study Staff:
More informationUS Policy Developments and Points to Consider for Genomics Research Informed Consent
US Policy Developments and Points to Consider for Genomics Research Informed Consent Marianna J. Bledsoe Independent Research Professional/Consultant Adjunct Assistant Professor George Washington University
More informationFrequently Asked Questions
Frequently Asked Questions Genetics Defined What does DNA stand for? DNA stands for deoxyribonucleic acid. This term describes the different chemical building blocks that make up the structure of DNA.
More informationBroad consent for healthcare-embedded biobanking: understanding and reasons to donate in a large patient sample
Broad consent for healthcare-embedded biobanking: understanding and reasons to donate in a large patient sample Gesine Richter Institute of Epidemiology Christian-Albrechts-Universität zu Kiel, Germany
More informationParticipant Copy. No. Participation is voluntary. Your decision will not affect your health care at Mayo Clinic in any way.
Name and Clinic Number IRB # 08-007049 00 Consent form approved July 16, 2015; This consent valid through July 15, 2016; 1. General Information About This Research Study Study Title: Mayo Clinic Biobank
More informationMolecular Diagnostics
Molecular Diagnostics Part II: Regulations, Markets & Companies By Prof. K. K. Jain MD, FRACS, FFPM Jain PharmaBiotech Basel, Switzerland May 2018 A Jain PharmaBiotech Report A U T H O R ' S B I O G R
More informationThe Importance of Feasibility Studies for Oncology Clinical Trials
The Importance of Feasibility Studies for Oncology Clinical Trials www.ppdi.com Executive Summary The segmenting of the oncology patient population has increased the challenges in designing clinical trials.
More informationSUNY Upstate Medical University. Stephen J. Glatt, Ph.D. Stephen V. Faraone, Ph.D
SUNY Upstate Medical University Stephen J. Glatt, Ph.D. Stephen V. Faraone, Ph.D. 315-464-7742 315-464-3113 Study Title: Longitudinal Family/Molecular Genetic Study to Evaluate Research Domain Criteria
More informationExome Sequencing Exome sequencing is a technique that is used to examine all of the protein-coding regions of the genome.
Glossary of Terms Genetics is a term that refers to the study of genes and their role in inheritance the way certain traits are passed down from one generation to another. Genomics is the study of all
More informationNanthealth Patient Informed Consent
Patient Informed Consent Why am I being asked to give consent? You are being asked to sign this consent form because you want to have a molecular/genomic analysis performed to help your physician understand
More informationannex 3. Template consent form for biobanking
annex 3. Template consent form for biobanking This template is based on Public Population Project in Genomics and Society (P3G) database resources. General considerations The information brochure and consent
More informationSema4 CarrierCheck Informed Consent
Sema4 CarrierCheck Informed Consent [last modified July 20, 2017] This informed consent describes the benefits, risks, and limitations of undergoing DNA testing for certain genetic conditions with Sema4
More informationTrue/False Comprehension Assessment for Biobanking English
True/False Comprehension Assessment for Biobanking English The format for this document is: INFORMED CONSENT TOPIC AREA Delphi statement: A statement of the essential information a prospective participant
More informationTOTAL CANCER CARE: CREATING PARTNERSHIPS TO ADDRESS PATIENT NEEDS
TOTAL CANCER CARE: CREATING PARTNERSHIPS TO ADDRESS PATIENT NEEDS William S. Dalton, PhD, MD CEO, M2Gen & Director, Personalized Medicine Institute, Moffitt Cancer Center JULY 15, 2013 MOFFITT CANCER CENTER
More informationThe Tension Between Policy and Practice in Returning Research Results and Incidental Findings in Genomic Biobank Research
Minnesota Journal of Law, Science & Technology Volume 13 Issue 2 Article 11 2012 The Tension Between Policy and Practice in Returning Research Results and Incidental Findings in Genomic Biobank Research
More informationPersonalized Human Genome Sequencing
Personalized Human Genome Sequencing Dr. Stefan Platz DABT, Global Head Drug Safety & Metabolism Biomedical research: strengths & limitations of non-animal alternatives 06 December 2016 The Human Genome
More informationInformed Consent in Translational Genomics: Insufficient Without Trustworthy Governance
Informed Consent in Translational Genomics: Insufficient Without Trustworthy Governance Wylie Burke, Laura M. Beskow, Susan Brown Trinidad, Stephanie M. Fullerton, and Kathleen Brelsford Introduction Translational
More informationHUMAN GENETICS INITIATIVE
Clinical Protocol HUMAN GENETICS INITIATIVE Ancillary Study to A Comparison of Long-Acting Injectable Medications for Schizophrenia (ACLAIMS) National Institute of Mental Health Grant R01-MH081234 and
More informationEthics of disclosing results of genetic testing of donor-derived leukemia to recipient in a. hereditary cancer biology research setting
Ethics of disclosing results of genetic testing of donor-derived leukemia to recipient in a hereditary cancer biology research setting Connie Phung, M.S. 1 1 The University of Chicago, Department of Medicine,
More informationShort Title: CCI Biobank
Patient Label Stamp or letterhead of the department Patient Information Donation, Storage and Use of Biological Materials and Collection, Processing and Use of Data of the CCI Biobank, Medical Center -
More informationVolunteering for Clinical Trials
Volunteering for Clinical Trials Volunteering for Clinical Trials When considering volunteering for a clinical trial, it is important to make an informed decision. Below are answers to frequently asked
More informationYou are the parent or guardian granting permission for a child to enroll in the Biobank.
Approval : April 22, 2015 Please check one of the following: You are an adult participant enrolling in the Biobank. You are the parent or guardian granting permission for a child to enroll in the Biobank.
More informationPatient Handbook on Stem Cell Therapies
Patient Handbook on Stem Cell Therapies WWW.ISSCR.ORG WWW.CLOSERLOOKATSTEMCELLS.ORG Patient Handbook on Stem Cell Therapies Introduction We have all heard about the extraordinary promise that stem cell
More informationQuestion 01 - Health care as a consumer good
Question 01 - Health care as a consumer good The expanding array of medical products and services becoming available as consumer goods outside traditional medical settings raises the stakes on regulating
More informationEIGHT BASIC ELEMENTS OF INFORMED CONSENT
1/6 This guidance addresses: o Eight Basic elements of informed consent o Additional elements of informed consent o Other information required by the IRB EIGHT BASIC ELEMENTS OF INFORMED CONSENT Required
More informationGENETIC TESTING A Resource from the American College of Preventive Medicine
GENETIC TESTING A Resource from the American College of Preventive Medicine A Time Tool for Clinicians ACPM's Time Tools provide an executive summary of the most up-to-date information on delivering preventive
More informationAnnex VIIIB Paragraphs to be included in the Informed Consent Form for the collection and use of biological samples in clinical trials
DEPARTAMENTO DE MEDICAMENTOS DE USO HUMANO Annex VIIIB Paragraphs to be included in the Informed Consent Form for the collection and use of biological samples in clinical trials Version 20 th December
More informationPresentation to the Committee on Accelerating Rare Disease Research and Orphan Product Development
Presentation to the Committee on Accelerating Rare Disease Research and Orphan Product Development 23 November 2009 Sharon F. Terry, MA President & CEO, Genetic Alliance Executive Director, PXE International
More informationPractice Based Competencies For Canadian Genetic Counsellors
Practice Based Competencies For Canadian Genetic Counsellors Contents Acknowledgements....3 Preamble. 4 Background....4 Overview. 5 Assumptions...6 Competency Domains 6 1. Counselling and Communication
More informationEthical Governance Framework
Ethical Governance Framework Version 1.1, April 2013 1 of 18 Contents Contents... 2 Definition of terms used in this document... 3 1 Introduction... 5 1.1 Project aims... 5 1.2 Background for the Ethical
More informationGenomics and personalised medicine
Genomics and personalised medicine Dr Tom Fowler, Deputy Chief Scientist & Director of Public Health WHO Symposium on the Future of Digital Health Systems in the European Region February 2019 About me
More informationFIRST NAME MI LAST NAME BIRTH DATE (MM/DD/YYYY) GENDER. Specify countries: Name of person previously tested and relationship:
REQUEST FOR SITE SPECIFIC ANALYSIS [APC / MYH / TP53 / MLH1 / MSH2 / MSH6] Please provide the following information. We cannot perform your test without ALL of this information. PLEASE PRINT ALL ANSWERS
More informationProposed Recommendations of the European Society of Human Genetics
Genetic Testing and Common Disorders Proposed Recommendations of the European Society of Human Genetics DRAFT version 18 May 2009, PLEASE DO NOT QUOTE Introductory considerations After the focus on monogenic
More informationComments on Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants
Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 The American Society of Human Genetics 9650 Rockville Pike Bethesda, MD 20814 24 December
More informationDefinition of Human Subject (94% oppose, 3% support, 3% support with qualifiers)
Research Universities and Institutions; Medical Centers and Schools of Medicine; Academic Institutional Review Boards and University and Medical Center Staff Preliminary Findings from a Review of Responses
More informationStanford University IRB Guidance On Data and Tissue Repositories
Stanford University IRB Guidance On Data and Tissue Repositories Databases, registries (data banks), and repositories (tissue banks) all involve the collection and storage of information and/or biological
More informationUniversity of New Mexico Health Sciences Center Office of Research Policy for the Oversight of Human Tissue in Research
1. Applicability This policy applies to all tissues collected from volunteers and from nonliving human subjects for the purpose of research. Oversight of this policy and these tissues are the responsibility
More informationDelivering the NIHR Central Commissioning Facility
Delivering the NIHR Central Commissioning Facility About the NIHR The National Institute for Health Research is funded through the Department of Health to improve the health and wealth of the nation through
More informationGenetic data and electronic health records: a discussion of ethical, logistical and technological considerations
Genetic data and electronic health records: a discussion of ethical, logistical and technological considerations Informatics Journal Club Webinar August 01, 2013 Kimberly Shoenbill, Norman Fost, Umberto
More informationREQUEST FOR HEMOPHILIA B (FACTOR IX DEFICIENCY)
REQUEST FOR HEMOPHILIA B (FACTOR IX DEFICIENCY) Please provide the following information. We cannot perform your test without ALL of this information. PLEASE PRINT ALL ANSWERS PATIENT INFORMATION* FIRST
More informationCOPE. FAQs CORPORATE ONCOLOGY PROGRAM FOR EMPLOYEES
COPE CORPORATE ONCOLOGY PROGRAM FOR EMPLOYEES FAQs This brochure addresses FAQ and is prepared solely for the German market. Local adjustments may be necessary. Please contact us if you require additional
More informationThe Intersection of Genomics Research and the IDE Regulation
The Intersection of Genomics Research and the IDE Regulation Katherine Donigan, Ph.D. Personalized Medicine Staff FDA/CDRH/OIR October 19, 2017 1 In Vitro Diagnostic (IVD) Regulation Through the 1976 medical
More informationVirtual Mentor American Medical Association Journal of Ethics August 2009, Volume 11, Number 8:
Virtual Mentor American Medical Association Journal of Ethics August 2009, Volume 11, Number 8: 621-625. HEALTH LAW Donors Retain No Rights to Donated Tissue Kristin E. Schleiter, JD, LLM Autonomy has
More informationWMA Declaration of Helsinki Ethical Principles f or Medical Research Involving Human Subjects
WMA Declaration of Helsinki Ethical Principles f or Medical Research Involving Human Subjects Note: Modifications and insertions highlighted and compared to previous 2008 wording by Gillian Vale, Administrator,
More informationA New Era of Clinical Diagnostics: How the Business Model is Changing.
A New Era of Clinical Diagnostics: How the Business Model is Changing. Nancy J Kelley, President and CEO of Nancy J Kelley & Associates Remarks to BTIG Emerging Technologies in Healthcare Diagnostics September
More informationCAN GDPR WORK FOR HEALTH SCIENTIFIC RESEARCH? BRUSSELS OCTOBER 22 ND CIPL EFPIA FPF EXECUTIVE SUMMARY
CAN GDPR WORK FOR HEALTH SCIENTIFIC RESEARCH? BRUSSELS OCTOBER 22 ND 2018 - CIPL EFPIA FPF EXECUTIVE SUMMARY Despite many actors good intentions, the health research sector has so far survived GDPR rather
More information- OMICS IN PERSONALISED MEDICINE
SUMMARY REPORT - OMICS IN PERSONALISED MEDICINE Workshop to explore the role of -omics in the development of personalised medicine European Commission, DG Research - Brussels, 29-30 April 2010 Page 2 Summary
More informationData Sources and Biobanks in the Asia-Pacific Region. Wei Zhou, MD, Ph.D. Department of Epidemiology, Merck Research Laboratories October 23, 2014
Data Sources and Biobanks in the Asia-Pacific Region Wei Zhou, MD, Ph.D. Department of Epidemiology, Merck Research Laboratories October 23, 2014 1 Disclosures Wei Zhou is currently an employee of Merck
More informationRules of Human Experimentation
Rules of Human Experimentation Elaine Larson CUMC IRB Chair Associate Dean for Research, School of Nursing Professor of Epidemiology, Mailman School of Public Health Oversight for Human Research Office
More informationEthical Principles in Clinical Research. Disclaimer. Christine Grady Department of Bioethics NIH Clinical Center
Ethical Principles in Clinical Research Christine Grady Department of Bioethics NIH Clinical Center Disclaimer The views expressed are mine and do not necessarily represent the positions or policies of
More informationA Path to Social Licence
August 2017 A Path to Social Licence Guidelines for Trusted Data Use A Path to Social Licence Guidelines for Trusted Data Use 1 1 2 August 2017 A Path to Social Licence Guidelines Summary for June August
More informationHRPP Policy No. 714 Effective Date 09/01/10 Revisions Date. Genome Wide Association Studies
Genome Wide Association Studies HRPP Policy No. 714 Effective Date 09/01/10 Revisions Date 1.0 Purpose This policy describes how investigators at the University of South Florida (USF) and USF Affiliates
More informationCommunity Health Initiative
Community Health Initiative Andy Faucett, MS, LGC Geisinger Health System IOM Roundtable on Translating Genomic-Based Research for Health November 19, 2015 wafaucett@geisinger.edu geisinger.org/genomics
More informationExperiences from Electronic Health Records (EHRs) and what we can expect in the future
Emerging Approaches for Environmental Health Data Integration Experiences from Electronic Health Records (EHRs) and what we can expect in the future Marylyn D. Ritchie, PhD Department of Genetics Institute
More informationINTERDISCIPLINARY COLLABORATIONS MEDICAL RECORDS AND GENOMICS (EMERGE) NETWORK AND EHRS: THE ELECTRONIC. October 30, 2015
INTERDISCIPLINARY COLLABORATIONS AND EHRS: THE ELECTRONIC MEDICAL RECORDS AND GENOMICS (EMERGE) NETWORK October 30, 2015 Dana C. Crawford, PhD Associate Professor Epidemiology and Biostatistics Institute
More informationSlides are from Level 3 Biology Course Content Day, 7 th November Presenter: Justin O Sullivan
Slides are from Level 3 Biology Course Content Day, 7 th November 2012 Presenter: Justin O Sullivan Teachers are free to use these for teaching purposes with appropriate acknowledgement Personalized genomics
More informationNext Generation Medicine?
Next Generation Medicine? Ethical, Legal and Technological Questions of Genomic High-Throughput Sequencing in the Clinic Date July 25 / 26 2017 Venue University Medical Center Goettingen, Lecture Hall
More informationFinal Rule Material: Secondary Research with Identifiable Information and Biospecimens
2017 Biomedical Research Alliance of New York LLC CITI Program is a division of BRANY Final Rule Material: Secondary Research with Identifiable Information and Biospecimens www.citiprogram.org Content
More informationREQUEST FOR RETINOBLASTOMA TESTING
REQUEST FOR RETINOBLASTOMA TESTING Please provide the following information. We cannot perform your test without ALL of this information. PLEASE PRINT ALL ANSWERS PATIENT INFORMATION* FIRST NAME MI LAST
More informationMohammed Al Jumah. King Abdullah International Medical Research Center KSAU-HS NGHA
Mohammed Al Jumah King Abdullah International Medical Research Center KSAU-HS NGHA Introduction Research Ethics NCBE Research & Ethics Interactions Clinical practice and Research Fair Access of research
More informationHuman Genome Editing: Science, Ethics, and Governance Highlights for Industry Stakeholders
Human Genome Editing: Science, Ethics, and Governance Highlights for Industry Stakeholders Background Advances in genome editing, especially the CRISPR/Cas9 genome editing system, have generated tremendous
More informationPrecision Medicine: Its Promises and Pitfalls Melissa S. Creary, PhD, MPH Health Management and Policy U-M School of Public Health
Precision Medicine: Its Promises and Pitfalls Melissa S. Creary, PhD, MPH Health Management and Policy U-M School of Public Health Today s Outline 1. How did we get here? 2. Personalized vs. Precision
More informationRecruitment of Subjects Best Practices
UCLA CTSI WELCOME TO ONLINE TRAINING FOR CLINICAL RESEARCH COORDINATORS ROLE OF THE RESEARCH COORDINATOR Recruitment of Subjects Best Practices May 2016 Objectives Definitions Goals and Barriers Recruitment
More informationOutline of Discussion
This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are
More informationDana-Farber Cancer Institute Speeds Medical Research with Advanced Data Warehouse
Dana-Farber Cancer Institute Speeds Medical Research with Advanced Data Warehouse Dana-Farber Cancer Institute Boston, MA www.dana-farber.org Industry: Healthcare Annual Revenue: US$665.7 million Employees:
More informationEthics Committees/IRBs Today: Challenges for Efficiency and Quality
Marjorie A. Speers, Ph.D. President and CEO Ethics Committees/IRBs Today: Challenges for Efficiency and Quality Copyright 2013 AAHRPP All rights reserved Goal Clinical Research Globally Access to patients
More informationIDENTIFIABILITY OF THE HUMAN MICROBIOME: INVESTIGATOR PERSPECTIVES
IDENTIFIABILITY OF THE HUMAN MICROBIOME: INVESTIGATOR PERSPECTIVES Data Sharing Policies in Genomic Research Developed in the context of large-scale sequencing studies (HGP, HapMap) Primary purpose: create
More informationYour genes. Your roadmap. Health TechNet & Pharmacogenomics (PGx) February 16, Franziska Moeckel AVP, Personalized Health
Your genes. Your roadmap. Health TechNet & Pharmacogenomics (PGx) February 16, 2018 Franziska Moeckel AVP, Personalized Health Your genes. Your roadmap. Overview Inova s Precision Medicine Journey MediMap
More informationAUTHORIZATION TO USE AND DISCLOSE HEALTH INFORMATION
AUTHORIZATION TO USE AND DISCLOSE HEALTH INFORMATION I authorize the laboratory that has conducted or will conduct my genetic testing under the RPE65 Genetic Test Program and my physician to disclose to
More informationThe UK legislation is wholly retrospective and applies to all information held by public authorities regardless of its date.
FREEDOM OF INFORMATION POLICY INTRODUCTION The Freedom of Information (FOI) Act was passed in 2000 and replaces the Open Government Code of Practice that has been in place since 1994. The Act gives the
More informationInformed Consent for Columbia Combined Genetic Panel (CCGP) for Adults Please read the following
Informed Consent for Columbia Combined Genetic Panel (CCGP) for Adults Please read the following form carefully and discuss with your ordering physician/genetic counselor before signing consent. 1. The
More informationPERSONALISED MEDICINE FOR THE BENEFIT OF PATIENTS
PERSONALISED MEDICINE FOR THE BENEFIT OF PATIENTS CLEAR DIAGNOSIS TARGETED TREATMENT STRENGTHENED RESEARCH SUMMARY NATIONAL STRATEGY FOR PERSONALISED MEDICINE 2017-2020 FOREWORD Personalised Medicine
More informationAssuring Integrity while Facilitating Innovation in Medical Research
Assuring Integrity while Facilitating Innovation in Medical Research IMPACT OF CONFLICT OF INTEREST POLICIES ON INNOVATION June 5, 2013 IOM Proposed Questions What is the industry perspective on the impact
More informationThe 100,000 Genomes Project Genomics Collaboration Event Finnish Residence
The 100,000 Genomes Project Genomics Collaboration Event Finnish Residence Prof Mark Caulfield FMedSci Chief Scientist for Genomics England Barts Heart Centre William Harvey Research Institute Queen Mary
More informationWhile individually rare, orphan diseases are actually collectively common, with an OF ORPHAN DRUG DEVELOPMENT MEETING THE UNIQUE CHALLENGES
ELECTRONICALLY REPRINTED FROM JUNE 2017 CLINICAL TRIALS Rare Diseases: MEETING THE UNIQUE CHALLENGES OF ORPHAN DRUG DEVELOPMENT BY MICHAEL F. MURPHY, MD, Ph D While individually rare, orphan diseases are
More informationSupplementary Materials for
www.sciencetranslationalmedicine.org/cgi/content/full/6/242/242cm6/dc1 Supplementary Materials for Sandbox: Building and Sharing Resources This PDF file includes: Mark David Lim E-mail: mlim@fastercures.org
More informationThe HUNT Study and potential for innovation and industry research collaboration
1 The HUNT Study and potential for innovation and industry research collaboration Professor Kristian Hveem, MD, PhD, Director of HUNT biobank, NTNU Head of Biobank Norway (BBMRI.no) Head of K.G. Jensen
More informationNHS ENGLAND BOARD PAPER
NHS ENGLAND BOARD PAPER Paper: PB.30.03.2017/06 Title: Creating a genomic medicine service to lay the foundations to deliver personalised interventions and treatments Lead Director: Professor Sir Bruce
More informationGene Therapy and Ethics: the Patient View. A tool for public dialogue
Gene Therapy and Ethics: the Patient View A tool for public dialogue Colofon This brochure has been developed by the European Genetic Alliances' Network EGAN. You are allowed to download, print or copy
More informationNIH Policy Priorities for Clinical Research
NIH Policy Priorities for Clinical Research Kathy Hudson, Ph.D. Deputy Director for Science, Outreach, and Policy, NIH Federal Demonstration Partnership January 12, 2015 Topics Clinical Trial Results Reporting
More informationIssues in genetic testing for ultra-rare diseases: background and introduction David H. Ledbetter, PhD, and W. Andrew Faucett, MS
May 2008 Vol. 10 No. 5 commentary Issues in genetic testing for ultra-rare diseases: background and introduction David H. Ledbetter, PhD, and W. Andrew Faucett, MS Since 1994, at least three national advisory
More informationOptimize Your Phase I Healthy Trial Design
Optimize Your Phase I Healthy Trial Design 06/20/18 description Trial designs should optimize study flexibility and subject protection, leveraging all pertinent knowledge to maximize data collection and
More informationThe 100,000 Genomes Project
The 100,000 Genomes Project Dr Tom Fowler, Deputy Chief Scientist Genomics England Jillian Hastings Ward, Chair, National 100K Participant Panel The Kings Fund, 6th October 2017 Our Mission 100,000 whole
More information