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.

I. 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.

1. NCI Documents

   NCI Brochure: Donating Your Blood, Tissue and Other Samples
   http://biospecimens.cancer.gov/global/pdfs/MedicalResearchPatientBrochure-508.pdf

   NCI ELSI Workshop Summaries:

   1. NCI Think Tank on Identifiability of Biospecimens and 'Omic Data http://epi.grants.cancer.gov/events/identifiability/#summary
   2. Workshop on Release of Research Results to Participants in Biospecimen Studies
      http://biospecimens.cancer.gov/resources/publications/workshop/rrra.asp
   3. Workshop on Ethical Use of Pediatric Biospecimens in Research
      http://biospecimens.cancer.gov/resources/publications/workshop/eupbr.asp
   4. Workshop on Custodianship and Ownership in Biospecimen Research
      http://biospecimens.cancer.gov/global/pdfs/CaOSumm.pdf
   5. International Symposium to Harmonize Biorepository Practices
      http://biospecimens.cancer.gov/global/pdfs/Barker20051110_summary.pdf

2. Documents from Other Sources

   The President’s Commission for the Study of Bioethical Issues http://www.bioethics.gov/ recently published two key reports impacting research involving biospecimens and biospecimen resources. The first (October 2012) examines the use of biospecimens to conduct whole genome sequencing, including considerations or informed consent, privacy and data sharing: http://bioethics.gov/sites/default/files/PrivacyProgress508_1.pdf. The second: http://bioethics.gov/node/3186 (December 2013) explores the ethical issues surrounding the return of incidental findings in research involving biospecimens.

   The Secretary’s Advisory Committee on Human Research Protection (SACHRP) developed a document addressing a number of practical and regulatory issues about the collection, storage, distribution, and future research use of biospecimens and associated data. These issues were deliberated over the course of several SACHRP meetings in 2009-2010. The final recommendations take the form of a series of “Frequently Asked Questions, each presented as a commonly-encountered scenario and a suggested response addressing both regulatory and ethical human subject concerns. The goal was to provide a framework for IRBs, institutions and investigators to consider individual research scenarios without prescribing specified outcomes, recognizing that each decision will always be fact-specific. The recommendations can be found on NCI’s website at http://www.cancerdiagnosis.nci.nih.gov/resources/elsi/
   secretarys_advisory_committee.htm

   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/Subpage.aspx?id=1929

   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.
   https://bioethicsarchive.georgetown.edu/nbac/pubs.html

   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/

II. 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.

1. NCI Documents

   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

   The Genotype-Tissue Expression (GTEx) Project
   The NCI and National Human Genome Research Institute have developed an informed consent document for the Genotype-Tissue Expression (GTEx) project. GTEx is a NIH Common Fund project that is collecting biospecimens and clinical data from 900 non-diseased postmortem donors. This document provides a sample for obtaining assent from next-of-kin or a family decision maker to obtain and use these tissues for genomic and other research endeavors.

   Sample GTEx Informed Consent Document

2. 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://p3g.org/resources

   Sample consent form:
   http://p3g.org/system/files/biobank_toolkit_documents/P3G%20Generic%20Info%20Pamphlet
   %20and%20Consent%20Form%20for%20Biobanks_0.pdf

   Biobank tool kit:
   http://p3g.org/resources/biobank-toolkit

III. 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.

1. 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/learningabout/patientsafety/informedconsent

   Providing Your Tissue for Research
   This six-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

2. 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/

IV. 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.

1. NCI Documents

   NCI Consent Template for Adult Cancer Trials (May 12, 2013):
   The NCI, in conjunction with a working group of multidisciplinary experts, created a consent template for use in adult cancer trials. A web search for NCI Consent Template for Adult Cancer Trials will lead to the Word document.

   FDA informed consent information sheet from 2014. This guideline on informed consent provides guidance for IRBs, clinical investigators, and sponsors.
   http://www.fda.gov/RegulatoryInformation/Guidances/ucm404975.htm

2. 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

   This letter from AAMC provides feedback on the FDA guidance on informed consent.
   https://www.aamc.org/download/404310/data/aamccommentsonfdasdraft
   guidanceoninformedconsent.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.
   https://www.grouphealthresearch.org/about-us/capabilities/research-communications/prism/