HRP-109 Student Handbook: A Guide to Human Subjects’ Protection in Research, Version Date 1.21.22 Page 17
Belmont Report identify some groups they deem vulnerable: pregnant women, human fetuses, neonates,
prisoners, children, persons with physical handicaps or mental disabilities, persons who are
disadvantaged economically or educationally, racial minorities, the very sick and the institutionalized.
Additionally, some individuals may be situationally vulnerable because of the type of research or an offer
of participation in it. For example, persons may feel obligated or coerced to enroll in research because of
real or perceived differences in role relationships (such as, between students and teachers in school
research; patients and caregivers or providers in health care research; employees and supervisors in
organizational research, prisoners and wardens in prison research, to name a few). As a result, additional
design elements often need to be built into the protocol plan, the recruitment plan, and/or the consent
(or assent/parental permission) process to protect persons’ autonomy to make decisions in their self-
interests.
To learn more about additional protections for vulnerable persons in research, go our Guidance Topics
online: https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-
protection-program-irbs/hspp-guidance-topics . You can also find links to The Common Rule and FDA
regulations on the topic, as well as a link to The Belmont Report:
https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-
program-irbs/policies-and . You will also find on that page NJ State Statutes, and University policy
regarding required protections of special populations, as well as related protocol, consent and assent
templates, on how best to protect vulnerable populations.
Your Faculty Advisor and IRB staff are available to help you think through what appropriate additional
strategies are necessary to protect vulnerable persons in your research, if applicable.
HIPAA Privacy Rule
As outlined above [See What Does the IRB Consider, criteria #7 in this Section], the Common Rule requires
researchers to protect subjects’ private information, regardless of the data source—from whom or
where—the information was obtained. However, another federal regulation also exists to protect
subjects’ private information, but it is narrowly focused on just one data source—patients’ electronic
medical records. The Health Insurance Portability and Accountability Act otherwise known as the “HIPAA
Privacy Rule”, demands researchers protect the confidentiality and security of patients’ personally
identifiable health information found specifically in patients’ electronic medical records. Among other
things, HIPAA regulates when researchers may access and use such information also known as Protected
Health Information, or PHI.
To qualify as protected health information, or PHI, the information must possess three qualities:
(1) it must include one of 18 identifiers deemed capable of identifying an individual;
a. To see the list of 18 identifiers, go to: See Guidance Topics online, then click upon the
“Health Insurance Portability and Accountability Act (HIPAA) and Protected Health
Information (PHI)” topic section.
(2) it must relate to a person’s health, health care, or payment of health care;
a. Examples of health information would include, any information in a patient’s medical
chart, lab values, results of diagnostic testing or imaging, psychological tests, biological
specimens, billing documents, etc.
(3) it must exist in an institution, organization or business that electronically transmits such health
information to accomplish a health-related transaction;
a. Examples of covered entities include hospitals, health care clinics or business entities that
support the services of a hospital or health care clinic care clinic.