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Ethical, Legal and Social Implications of Biobanking in Cancer Research
Ethical, Legal and Social Implications of Biobanking in Cancer Research
The ethical, legal, and social implications (ELSI) of cancer research are increasingly complex and require careful attention from researchers, especially when biological samples and associated data are collected for potential genetic or genomic studies. Protecting the rights and welfare of biospecimen donors involves ethical considerations as well as regulatory compliance. Researchers should be aware of best practices in the following areas:
- Biobank governance and custodianship obligations
- Engagement of research participants as partners, and respectful engagement of research communities
- Models of consent for secondary and future research uses of collected biological samples and genetic data
- Researcher access to potentially identifiable information
- Promoting data sharing and data security
- Return of research results and incidental findings
Explore the following resources for more information on ELSI related to cancer research and biobanking.
The ENRICH Forum
NCI’s ENRICH Forum (Ethical aNd Regulatory Issues in Cancer ResearcH) invites speakers to discuss critical, timely and often controversial ELSI issues involved in cancer research. Sessions are open to the NIH community and to the public, via webinar. ENRICH programming is designed to encourage dialogue around ethical and regulatory topics and promote awareness of developing policies and best practices.
The ENRICH Forum is sponsored by the Division of Cancer Treatment and Diagnosis (DCTD) and the Division of Cancer Control and Population Sciences (DCCPS). To see the schedule of upcoming webinars, or view recordings of past Forums, please visit the ENRICH website.
For Researchers
Federal requirements to protect human subjects apply to most federally funded or sponsored research that uses human specimens, residual diagnostic specimens, and medical information. The following resources can help you understand what these regulations mean for researchers.
- Office of Human Research Protections (OHRP)
OHRP provides leadership and guidance in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). - Office of Human Subjects Research Protections (NIH Office of Intramural Research)
The Office of Human Subjects Research Protections (OHSRP) carries out day-to-day operations and regulatory oversight of human research activities within the Human Research Protections Program (HRPP). The OHSRP promotes the protection of rights, safety and welfare of human subjects. - NIH Bioethics Interest Group
The Bioethics Interest Group provides a discussion forum, considers different views, and presents research on complex ethical issues. Ethical issues involving research with individual humans and with communities, as well as research with animals, are addressed. The group also discusses research integrity and scientific conduct. - Federal Regulations and the Ethical Collection of Research Specimens and Data
Start here for an overview and brief history of the regulations and associated policy guidance - Informed Consent
- Data Sharing: Privacy and Confidentiality
For Patients and Advocates
Federal requirements to protect human subjects apply to most research that uses human specimens, residual diagnostic specimens, and medical information. The following resources can help you understand what happens when patients decide to participate in cancer clinical trials and donate their biological samples and data.
- Donating specimens or data to cancer research
- What is Research?
Watch this informational video series from the U.S. Department of Health and Human Services Office for Human Research Protections. - Informed Consent in Cancer Clinical Trials
Read NCI’s overview of the consent process for patients considering participating in clinical trials - What does randomization mean for research volunteers?
This video explains the concept of randomization in research studies and what potential participants need to know when volunteering for a study with a randomized design. - Questions to ask when deciding whether to volunteer for research
This brochure provides commonly asked questions to consider when deciding whether to be a research participant - Video: Protecting Your Privacy in Human Research
OHRP’s video on “Protecting Your Privacy in Human Research” explains how researchers protect the privacy of research volunteers and keep their information secure.