Research with Vulnerable Populations

Research with vulnerable populations requires consideration of extra precautions to minimize undue influence and to protect the rights and wellbeing of human participants. Vulnerability may be contextual to the research and the participant population. While it’s difficult to create an exhaustive list, there are populations who are commonly included in research that are considered vulnerable, such as: students, employees, members of disenfranchised racial or ethnic communities, educationally disadvantaged persons, economically disadvantaged persons, individuals with mental illness and/or substance use disorders, members of disenfranchised groups, such as the LGBTQ+ community, etc.

Additionally, there are four vulnerable populations whose inclusion requires the submission of supplemental IRB forms: minors (individuals under the age of 18), pregnant people, incarcerated persons, and individuals with cognitive impairments. Submit the associated Subpart Determination Forms when conducting non-exempt research with each population. It’s not necessary to submit a subpart form for research that involves pregnant people if the study procedures (for example, interviews or surveys) would not affect the medical condition of the pregnant person or the fetus. Click below to access these forms.

Applicable State Laws

In addition to federal regulations, researchers have an obligation to follow any state laws that are stricter than federal regulations. Below are state law guidance topics that cover various topics that may need to be considered while planning a research study. For additional assistance on state laws, please contact the Office of General Counsel. 

Pennsylvania State Law:
The PA Law guidance document describes Pennsylvania laws on the following topics that are applicable to social-behavioral human research:

• Surrogate Consent for Cognitively Impaired Individuals
• Mandatory Reporting of Abuse
• Emancipation of Minors
• Minors’ Consent to Health Services

New Jersey State Law:
The NJ Law guidance document describes New Jersey laws on the following topics that are applicable to social-behavioral human research conducted in the state of New Jersey:

• “Medical Research” with Cognitively Impaired Adults [NJSA 26:14-3-5] including Surrogate Consent
• “Experimental Research” with Mental Health In-Patients [N.J.S.A. 30:4-24.2]
• Mental Health Records [N.J.A.C. 10:37-6.1]
• Research with Children [N.J.S.A. 9:17B-3; 9:17a-1]
• Prisoner Research within the State of NJ [N.J.A.C. 10A:1-10.1-10.6]

Survey/Interview Research

This page provides guidance to those conducting research that involves interpersonal interactions with participants such as surveys, interviews, and focus groups. This guidance includes help determining level of IRB review, consent considerations for audio and visual recording, and frequently asked questions for survey / interview research.

Research in Educational Settings

Research that takes place in established educational settings such as schools often qualifies for exempt review under category 1, even if minors are involved. Note that collection of especially sensitive data and/or work with particularly vulnerable minors may still require expedited or convened review, even if the research occurs in an established educational setting. In order to obtain IRB approval for research in educational settings such as schools, letters of study support from the institution(s) in which you will work are typically required. You may also need to obtain approval from a school or district research review committee such as The School District of Philadelphia or the New York City Department of Education in addition to IRB approval at Penn.

Research Outside of the United States

Those engaging in human subjects’ research in other countries should familiarize themselves with any local laws and /or cultural customs. The IRB strongly recommends having a research collaborator in the country in which you plan to conduct research to facilitate any necessary ethical committee reviews.

Local Approval

Research conducted outside of the United States typically requires local site approval, which can come in different forms depending on the level of review required and available ethics review mechanisms within the country in question. The IRB recommends reviewing DHHS’s International Compilation of Human Research Standards to determine what international regulations you may be required to follow. Examples of local site approval include confirmation of human subjects’ research review from an organization or university within the country or a letter of study support from a local organization or collaborator. More rigorous review of local site approval will be conducted for more complex protocols (e.g., clinical trials).

Research in the European Union

Consent materials for studies taking place in or collecting data from citizens of the European Union should be reviewed by the UPenn privacy office for compliance with GDPR laws. This includes studies that may be exempted. Please attach confirmation of your correspondence with the Privacy Office (e.g., a copy of an email exchange confirming that they reviewed your consent form) to your IRB application.

Consent for Minimal Risk Social-Behavioral Research

We often receive questions about whether researchers have to use the full social-behavioral consent template for minimal risk survey procedures or minimal risk interview procedures for which verbal consent may be obtained from adult participants. While you can use the full consent template for these types of studies, we understand that it may not be ideal. You can compose your own consent text. However, that text should include all required elements of consent, including information about future use of data. Note that this applies to minimal risk research with adults. Greater than minimal risk research, research with vulnerable populations, and/or more complex protocols like randomized control trials, even if minimal risk, may benefit from using the full social-behavioral consent template.