Data Management and Sharing

Research data from human subjects requires special considerations with regard to confidentiality and privacy.

Ethical considerations are the principles and rules that help ensure research and actions are done responsibly, fairly, and respectfully toward others and the environment. They guide us to act in ways that protect people's rights, avoid harm, and promote honesty and trust.

If your research involves data from human subjects,

• Consult UMass Lowell's Institutional Review Board (IRB) in the Office of Research Integrity as you work on data management and sharing plans 
• Adhere to the HIPAA Privacy Rule with regards to all protected health information associated with a dataset
• Include language in the Informed Consent document that addresses how the data will be shared. For more information, refer to the ICPSR guide to Recommended Informed Consent Language for Data Sharing and contact UMass Lowell's Institutional Review Board (IRB).

Remember, per the UML IRB website, research studies involving human subjects "must be reviewed and approved by the IRB before any study procedures begin, including recruitment or gathering of data.

In 1979, The U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Ethical Principles and Guidelines for the Protection of Human Subjects of Research.  The Belmont Report, as it is more commonly known, established three basic ethical principles of human research:

1. Respect for persons.
2. Beneficence. This principle goes beyond charity, and questions whether the potential for stigmatization or possible physical, emotional, or economic harm eclipses potential benefits of the research
3. Justice. Who is recruited to bear the burden of research and who receives the benefits?  This principle speaks to fair recruitment practices in research, and not exploiting disadvantaged people groups (prisoners, for example).

In light of these principles, keep in mind the following as you collect and analyze data:

• Consider how the research data you collect could stigmatize, or inflict physical, emotional, or economic harm on a people group.
  • Case study: Genetic Research among the Havasupai: A Cautionary Tale, AMA Journal of Ethics
• Incorporate and document ethical research practices in research data collection
  • The Arctic Data Center repository provides space in their data submission for researchers to describe their ethical research practices and publishes the statement with each dataset to promote transparency in data collection
• Ask questions such as -
  • Could my dataset be used intentionally or unintentionally to harm the peoples or cultures associated with my research?
  • If my research involved another people's land, did I ask for and receive permission?  Did I obtain the proper permits? Did I invite the community to participate? Did I account for culturally sensitive information?
  • How do members of the community perceive this research?  How would I perceive this research if I were a member of this community?

Contact UML Office of Research Integrity (ORI) if you have general questions concerning ethical research practices.  Please note that some research requires approval and monitoring by an ORI committee as often mandated by grant funding agencies:

• If your research involves human subjects.  As mentioned, the Institutional Review Board (IRB) at UML oversees all aspects of human research, including data management.
• If your research involves recombinant DNA (rDNA) or biohazardous materials.  The Institutional Biosafety Committee (IBC) at UML ensures the safe handling of rDNA and other biohazardous materials to protect researchers, the environment, and the public.
• If your research involves animals.  The Institutional Animal Care and Use Committee (IACUC) within the Animal Care Program at UML oversees all animal research and activities at UML to ensure appropriate care and ethical treatment  of animals used in research, testing or teaching.