Researchers Conducting Human Research
Conducting research with human participants in the field of substance use and addiction requires careful attention to ethical, methodological, and regulatory standards. The College on Problems of Drug Dependence (CPDD) supports researchers by outlining key considerations across various types of human research—from clinical trials and behavioral studies to neuroimaging and epidemiological investigations. This page provides guidance on best practices, ethical safeguards, and scientific rigor to ensure that human research is conducted responsibly and effectively.
Regulatory Guidelines and Ethical Considerations
When you run a study with people who use substances, you need to pair solid science with participant protections. You’ll start by getting Institutional Review Board (IRB) approval and safeguarding the participants’ data under SAMHSA’s Part 2 privacy rules. If your study entails an intervention, such as a medication or a device, it may fall under FDA or NIH oversight, so be sure to meet any IND/IDE and human subjects requirements.
Use clear, jargon-free consent forms that explain risks of stigma or feeling pressured, set up a safety monitoring plan for any adverse events, and follow Good Clinical Practice alongside core ethics guides like the Belmont Report and Declaration of Helsinki.
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Key Steps You’ll Take
- IRB Approval
Get institutional review board signoff before you enroll anyone.
- Privacy for SUD Data (42 CFR Part 2)
Follow SAMHSA rules to keep substance use records confidential.
- Informed Consent
Write consent forms in plain language, address stigma and coercion risks.
- Safety Monitoring
Have a data safety plan ready to spot and report adverse events quickly.
Additional Steps for Interventional Trials
- IND/IDE (FDA Authorization for Investigational Drugs & Devices)
If you directly administer a new drug (or if you are studying a new use of an existing FDA-approved drug), file an Investigational New Drug (IND) application or Investigational Device Exemption (IDE). You’ll submit your protocol, preclinical safety data, manufacturing details, and investigator credentials—and you must wait for FDA clearance before enrolling participants.
- DEA Controlled Substance Registration
Trials dispensing Schedule I–V drugs (e.g., opioids, cannabinoids, stimulants) also need DEA registration under 21 CFR 1300–1316. This covers secure storage, inventory/dispensing logs, and approved disposal protocols.
Handy Resources with Quick Descriptions
Types of Human Research
Survey/Observational Research
With observational studies, a researcher observes and measures variables, behaviors, or outcomes of interest without influencing or intervening with the population of interest directly. Surveys are a method of conducting observational research that involves collecting information about a group to learn about a larger population. Observational studies can employ the collection of quantitative, qualitative, or a combination of quantitative and qualitative data.
Clinical Trials
Clinical trials are research studies in which researchers assign participants to receive one or more interventions to test what happens in people. Because of this, clinical trials are also called interventional studies. Often, the intervention is investigational, which means it is not yet approved for doctors to prescribe to people. In some clinical trials, researchers assign participants to interventions randomly. This means that researchers assign the participants by chance. Usually, participants (or their doctors) don't choose what intervention they will get when they join a clinical trial. (ClinicalTrials.gov)
Implementation Science
Implementation science is a field of research focused on identifying ways to bring evidence-based practices (EBPs) into real-world clinical settings. These EBPs are typically derived from clinical trials, and implementation science focuses on how to best improve adoption and uptake of EBPs into clinical or routine practice. Rather than focus purely on patient characteristics, implementation science includes a focus on providers, organizations, and policies that can enable or inhibit implementation.
Neuroimaging
Neuroimaging is a set of non-invasive techniques that allow researchers to visualize and measure brain structure, brain function, and neurochemical processes. In addiction research, neuroimaging is used to investigate brain regions known to be affected by substance use and related behaviors, such as those involved in reward, decision-making, emotion regulation, and self-control.
Behavioral Pharmacology
Human behavioral pharmacology studies involve the experimental administration of drugs under controlled laboratory conditions. These studies often use within-subject designs (i.e., those in which participants receive all drug conditions in a randomized order) and can vary in the population enrolled (e.g., healthy participants, people with substance use disorder). Study goals may include evaluating basic behavioral or pharmacological mechanisms underlying drug action, testing potential medications for substance use disorder, or determining the potential for the misuse of novel drugs and drug combinations. Rigorous ethical and regulatory standards are applied to these studies to ensure the safety of participants.
This content was collated by the CPDD Human Research Committee and is meant to provide an overview for early-career investigators, trainees, and those who may be new to conducting clinical research. The resources below are not meant to be exhaustive, and investigators should always consult with their institutional IRB and regulatory for specific questions and guidance.