Focused Biomedical Initial Submission Guidance
This page covers special biomedical research topics that investigators should consider while designing a protocol for initial submission to the IRB.
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 human research:
- Surrogate Consent for Cognitively Impaired Individuals
- Mandatory Reporting of Diseases and Infections
- Mandatory Reporting of Abuse
- Emancipation of Minors
- Minors’ Consent to Health Services
- Nontherapeutic Research on “unborn children”
New Jersey State Law: The NJ Law guidance document describes New Jersey laws on the following topics that are applicable to human research:
- Research with Genetic Information [N.J.S.A. C.10:5-45-48]
- “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]
- Obtaining and Using Human Embryonic Stem Cells, Human Embryonic Germ Cells, and Human Adult Stem Cells for Research [NJ Rev Stat § 26:2Z-2 (2019)]
- Prospective Research Involving Drug Trials or Invasive Procedures Conducted in the Context of Advanced Life Support Services, Mobile Intensive Care Units, Specialty Care Transport Services, or Air Medical Services [N.J.A.C. 8:41-5.1]
- 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]
Inclusion of Pregnant Individuals in Research
The broad exclusion of pregnant individuals from research trials may eventually result in an overall lack of applicable knowledge regarding how best to treat pregnant individuals with concomitant medical conditions. Thoughtful, responsible study design aimed at appropriate inclusion of pregnant individuals, when possible, while maintaining fetal safety, is an important goal. The IRB has developed this guidance to assist researchers in addressing the many components that the IRB routinely considers when determining the appropriateness of including or excluding pregnant individuals in research.
Suicidal Ideation and Behavior: Risk Mitigation
Participants at risk of suicidal ideation and behavior are a vulnerable population group. Therefore, additional measures may be warranted to ensure their protection while they are enrolled in research studies. Additionally, participants in FDA-regulated clinical trials (including otherwise healthy volunteers) may also be at risk for suicidal ideation and behavior, when they are being administered:
- A drug being developed for any psychiatric indication,
- Any antiepileptic drug, and/or
- Other neurologic drugs with central nervous system (CNS) activity
When a research team is made aware of immediate suicide risk in a participant, there is an obligation and responsibility for timely and appropriate follow up to ensure participant safety. The intent of this document is to provide guidance on ensuring the safety of research participants who may be at risk of suicidal behavior.
Research at/with Good Shepherd Penn Partners (GSPP)
The purpose of the guidance document below is to provide a guide for researchers on the processes and expectations for investigators who wish to conduct human subject research at/with Good Shepherd Penn Partners (GSPP).
Morisky Medication Adherence Scale (MMAS) Research
Click below to download guidance from the Office of the General Counsel regarding MMAS Research [Morisky Medication Adherence Scale (MMAS-4 and MMAS-8].