Ask questions that match the type of study

Interventional and observational studies

Interventional studies assign a drug, device, procedure, behavioral program, diet, diagnostic strategy, or other intervention. Observational studies collect information without assigning an intervention under the study design. Both can require visits, records, questionnaires, specimens, devices, or long follow-up.

Ask which actions occur because of research, which care continues outside the study, and what direct benefit is expected, if any. An observational label does not guarantee low burden or zero privacy risk.

Drug and biologic trials

Ask about phase, dose, route, frequency, escalation, placebo or active comparator, interaction restrictions, rescue medication, adherence checks, pharmacokinetic blood draws, reproductive precautions, and access after the study. Record what happens when a dose is missed or a side effect occurs.

In early phases, the study may focus on safety, tolerability, dose, and how the product moves through the body. Larger later-phase studies provide additional safety information; rare or delayed risks may emerge only after approval. Phase alone cannot tell you the personal risk.

Device studies

Ask whether the device is implanted, worn, used at home, or controlled by staff. Confirm training, fitting, charging, maintenance, software updates, data transmission, alarms, skin effects, removal, return, and access after the study.

For implanted devices, find the surgical, anesthesia, imaging, maintenance, explant, failure, and long-term follow-up terms. Ask who pays for related care and what happens if the sponsor stops supporting the device.

Behavioral and digital studies

List session length, homework, coaching, recordings, diaries, notifications, app permissions, device requirements, data plans, accessibility, time zones, and missed-task rules. Ask whether staff monitor entries for urgent symptoms or whether the tool exists only for data collection.

Remote participation can shift work into the home. Count setup, troubleshooting, charging, shipping, measurements, and family disruption.

Imaging and procedure studies

Identify radiation, contrast, sedation, anesthesia, fasting, medication restrictions, claustrophobia support, pregnancy testing, transportation limits, recovery, incidental findings, and return of results. Ask whether images enter the medical record or remain research data.

For biopsies or other invasive procedures, ask how many samples are taken, whether the procedure is research-only, who performs it, where complications are treated, and who pays for injury care.

Biospecimen and genetic research

Ask what is collected, whether collection is optional, how samples are coded, how long they remain, which future studies may use them, whether genetic sequencing occurs, whether results are returned, and whether samples can support commercial products.

Clarify whether withdrawal can stop future use and what happens after a sample has been distributed or data have been de-identified.

Expanded access

FDA describes expanded access (opens in a new tab) as a potential U.S. pathway for a patient with a serious or life-threatening disease or condition to receive an investigational medical product for treatment outside a clinical trial when no comparable or satisfactory therapy is available and other conditions are met. A licensed physician, the company, an IRB, and FDA each have defined roles. Ask about eligibility, authorization, manufacturer agreement, physician responsibility, costs, monitoring, alternatives, and why trial enrollment is unavailable.