Appendix 2. Additional Resources Related to Ethical, Legal, and Policy Issues in Biospecimen Research

The resources listed below are not intended to be exhaustive but rather to provide useful examples and references for biospecimen resources. All Web links were last accessed on August 30, 2011.

General Resources Related to Ethical, Legal, and Policy Issues in Biospecimen Research
The reports and resources listed below provide an overview of ethical, legal, and policy challenges in biospecimen research. Topics include State and international regulations related to biospecimens and tools for institutional review boards (IRBs) and biospecimen resource managers.
- NCI Documents
  National Cancer Institute (NCI) 50-State Survey of Laws Regulating the Collection, Storage, and Use of Human Tissue Specimens and Associated Data for Research
  This survey reflects the status of state laws as of November 2004 that affect the use of biospecimens and associated data in research. The report includes a chart with the requirements for the conduct of biospecimen research State by State and a table compiling State statutes.
  http://www.cancerdiagnosis.nci.nih.gov/humanSpecimens/survey/50-state-survey.pdf
- Documents from Other Sources
  International Compilation of Human Research Protections
  This compilation was developed by the Office for Human Research Protections (OHRP) for IRBs/ethics committees, researchers, sponsors, and others who are involved in international research. The report includes a table for each country that lists the key organizations, legislation, regulations, and guidelines related to human biological materials.
  http://www.hhs.gov/ohrp/international/
  
  Public Responsibility in Medicine & Research (PRIM&R) Human Tissue/Specimen Banking White Paper
  The PRIM&R White Paper includes a discussion of the challenges and recommendations to the Federal regulatory and funding agencies as well as tools for IRBs, repository managers, and researchers in the form of educational materials, discussions of relevant issues, and points to consider.
  
  http://www.primr.org/PublicPolicy.aspx?id=68
  
  Research Involving Human Biological Materials: Ethical Issues and Policy Guidance—Volume I: Report and Recommendations of the National Bioethics Advisory Commission
  This 1999 report from the National Bioethics Advisory Commission (NBAC) addresses the question of whether the Common Rule is effective in protecting human subjects from harm in research involving biospecimens. The NBAC report also provides recommendations related to biospecimen research, including interpretations of several key terms and concepts in the Common Rule.
  
  http://bioethics.georgetown.edu/nbac/hbm.pdf
Sample Informed Consent Documents
The following list of sample informed consent documents is provided to guide and inform biospecimen resources about possible approaches to the informed consent process. These documents may be adapted depending on the nature of the resource and its mission.
- NCI Documents
  cancer Biomedical Informatics Grid (caBIG)
  Members of the caBIG Data Sharing and Intellectual Capital (DSIC) workspace have developed this combined informed consent and Health Insurance Portability and Accountability Act authorization template to facilitate biospecimen and data collection and sharing for research. This is a living document and will be further developed and revised over time.
  https://wiki.nci.nih.gov/display/DSIC/Model+Informed+Consent
  
  The Cancer Genome Atlas (TCGA)
  The NCI and the National Human Genome Research Institute have developed informed consent documents that are consistent with the goals and activities of TCGA, a comprehensive and coordinated effort to accelerate the understanding of the molecular basis of cancer through the application of genome analysis technologies. Both documents, one for retrospective biospecimen collections and another for prospective collections, specifically address genetic research, broad sharing of biospecimens and clinical data, the possibility of future research use, the deposition of genomics data into electronic database with partial public access, and the risk of loss of privacy.
  
  http://cancergenome.nih.gov/abouttcga/policies/informedconsent
- Documents from Other Sources
  Public Project in Population Genetics (P3G)
  P3G designed an informed consent template for use in prospective, longitudinal population genomics studies based on approaches used by P3G members.
  General information:
  http://www.p3gobservatory.org/repository/ethics.htm
  
  Sample consent form:
  http://www.p3gobservatory.org/download/Modelconsentform_Finalnov6.doc
  
  Sample patient information pamphlet:
  http://www.p3gobservatory.org/download/Modelinfosheet_Finalnov6.doc
Patient Information Documents
The following list of sample patient information documents is provided to guide and inform biospecimen resources about additional resources that may be useful during the informed consent process. These documents are intended to explain the informed consent process and/or the importance of biospecimens in research to a general audience and may be adapted depending on the nature and mission of the resource.
- NCI Documents
  Guide to Understanding Informed Consent
  This guide explains what a human research participant should expect during the informed consent process, explains the importance of the informed consent process to clinical human research participants, and describes how informed consent fits into a larger system that protects the welfare of people who take part in clinical trials.
  http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide
  
  Providing Your Tissue for Research
  This three-page booklet is meant to complement the face-to-face education that occurs between clinicians and potential clinical trial participants. It provides a balanced discussion of questions and answers on how biospecimens are collected and used in research.
  
  http://biospecimens.cancer.gov/global/pdfs/ProvidingYourTissueforResearch.pdf
- Documents from Other Sources
  Research Advocacy Network
  The Research Advocacy Network (RAN) is a nonprofit organization working to bring together all participants in the medical research process. The RAN has developed booklets about the importance of biospecimens in research directed toward human research participants and IRB members. Documents are available in English or Spanish.
  http://www.researchadvocacy.org/publications/posters.php
Resources for Simplifying Informed Consent Documents
Several groups have been established to provide recommendations on simplifying and improving the readability of informed consent documents. The following resources are not specific to biospecimen resources but instead provide general information on how to improve the informed consent process to meet the needs of human research participants.
- NCI Documents
  NCI-OHRP-FDA Initiative
  The NCI, along with the OHRP and the U.S. Food and Drug Administration, formed an Informed Consent Working Group to address concerns that informed consent documents for clinical trials were becoming too long, complicated, and difficult to understand. In 1998, the group issued "Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials." The recommendations may be used by investigators developing consent documents and by IRBs reviewing such documents.
  http://www.cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/
- Documents from Other Sources
  Association of American Medical Colleges
  The summary from a May 2007 strategic planning meeting titled "Universal Use of Short and Readable Informed Consent Documents: How Do We Get There?" includes a review of informed consent literature, potential approaches for improving informed consent, and success stories from the field.
  https://www.aamc.org/download/75282/data/hdicklermtgsumrpt53007.pdf
  
  Group Health Center for Health Studies
  The Project to Review and Improve Study Materials (PRISM) is a Group Health Center for Health Studies initiative to improve the readability of print materials used in communication with study participants. The PRISM Readability Toolkit is a comprehensive resource that includes sample informed consent language, editing checklists, a reference guide for improving readability, and examples of how to improve readability.
  
  http://www.centerforhealthstudies.org/capabilities/readability/readability_home.html