Use of Humans in Research
Any investigator conducting research involving human subjects must be well versed in the conceptual underpinnings of research versus therapy, risk versus benefit, informed consent, privacy, confidentiality, and special protections that may be needed for research with vulnerable populations. The investigator must be familiar as well with relevant ethical guidelines, laws, and regulations. The investigator will have interacted extensively with one or more institutional review boards (IRBs).
The Nuremberg Code, formulated in 1947, provided the foundation for other guidelines, most notably the World Medical Association’s Declaration of Helsinki. The Declaration of Helsinki was first published in 1964 and, through a series of amendments continues to prevail as the international standard for biomedical research involving human subjects.1 The Declaration of Helsinki is not a legally binding instrument under international or national law but instead draws its authority from the degree to which it has influenced, or been codified in, national or regional legislation and regulations. The Nuremberg Code and Declaration of Helsinki served as foundational guidelines for the creation of human subjects protections requirements in the United States, under the National Research Act of 1974.
The National Research Act first formalized the requirement for Institutional Review Board (IRB) review of federally-funded research. IRBs are committees of defined composition that are charged with review and oversight of studies in which human subjects are enrolled. Penn has nine IRBs that review biomedical and social/behavioral research.
The National Research Act also mandated formation of a presidential National Commission for Protection of Subjects of Biomedical and Behavioral Research, which in 1979 issued the Belmont Report. The three principles of the Belmont Report – Respect for Persons (autonomy), Beneficence (maximize benefit/minimize harm), and Justice (equal distribution of benefits and burdens) – serve as the primary ethical principles that guide IRB review. The ethical principles are applied through what’s often called the “Common Rule.”
For a concise description of the Nuremberg Code, use this link: https://www.ushmm.org/information/exhibitions/online-exhibitions/special-focus/doctors-trial/nuremberg-code
For information regarding the Common Rule, use this link: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
1Scientific Integrity, Macrina, ASM Press, 4th Edition.
Policies and Guidelines
Adapted from Penn’s Institutional Review Board (http://www.upenn.edu/IRB/mission-institutional-review-board-irb):
Any research utilizing human participants, regardless of risks imposed by the research, requires approval by an Institutional Review Board. Research is defined as a systematic investigation, including research development, and testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject/participant is an individual about whom an investigator conducting research obtains data through intervention or interaction with individual or identifiable private information.
Anyone submitting to the IRB board must first complete CITI –Protection of Human Subjects Research Training courses to fulfill the University’s requirement for training in human subjects protection. If CITI training has not been completed, or is not up to date, the IRB electronic application system will flag the submission and will not be approvable until this is completed. Training is web based and can be accessed through the CITI Program at www.citiprogram.org.
In addition the Perelman School of Medicine also requires all faculty, staff, and students to complete HIPAA (Health Insurance Portability and Accountability Act) training to maintain compliance with Penn Medicine privacy policies. Training is web-based and can be accessed through Knowledge Link.
Two textbooks provide excellent discussions of the use of humans in biomedical research. Responsible Conduct of Research, A.E. Shamoo and D.B. Resnick, 3rd ed., provides a very large number of historical case studies that have shaped policy and an especially good discussion of conceptual elements (research vs therapy, informed consent, etc.) underlying decision points in human studies. Scientific Integrity, F.L. Macrina, 4th ed., provides an extensive discussion of IRBs, vulnerable populations, and HIPAA. Both books are electronically accessible through the Biomedical Library.
The home page for Penn’s Institutional Review Board: http://www.upenn.edu/IRB/mission-institutional-review-board-irb
For a concise description of the Nuremberg Code: https://www.ushmm.org/information/exhibitions/online-features/special-focus/doctors-trial/nuremberg-code
For information regarding the Common Rule: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html