Understand what Phase 1 is designed to learn

FDA describes Phase 1 (opens in a new tab) as early human research that examines safety, dosage, how a drug interacts with the body, and side effects as exposure changes. Phase 1 can involve healthy volunteers or people with the condition, depending on the product and disease.

Ask what is already known, what remains unknown, which dose or cohort you may enter, and whether any participants have received the product. Do not translate “first in human” or “healthy volunteer” into a personal risk estimate without the consent discussion.

Request the cohort and dosing plan

Ask whether the study uses single ascending dose, multiple ascending dose, food-effect, drug-interaction, bioavailability, or another design. Record the planned dose, route, dosing day, sentinel process, stagger between participants, escalation decision, placebo ratio, and conditions that pause dosing.

Ask what the safety review has learned from earlier cohorts and what information can be shared. Confirm emergency unblinding and the after-hours clinical contact.

Build a line-by-line schedule

Count prescreening, screening, check-in, confinement nights, dosing, observation, outpatient visits, and phone follow-up. Ask for the blood-draw count and approximate total volume, meal schedule, sleep interruptions, urine collection, ECGs, vital signs, monitoring, and discharge criteria.

Mark standby or alternate-participant status. Ask whether you can be checked in and released without dosing, how that decision is made, and what payment accrues.

Map every restriction to dates

Record restrictions on prescriptions, over-the-counter products, supplements, nicotine, cannabis, alcohol, caffeine, grapefruit or other foods, exercise, blood donation, driving, sun exposure, and other studies. Record reproductive precautions and the end date for each requirement.

Never stop a needed medication to qualify without the study investigator and your clinician. Report new care, illness, vaccination, dental work, or medication changes when the protocol requires it.

Inspect confinement conditions

Ask about sleeping arrangements, bathrooms, privacy, work access, phone and visitor rules, dietary accommodation, personal belongings, nicotine policy, outdoor access, infection control, accessibility, and how staff respond to symptoms. Confirm what delays discharge and what transportation rules apply after dosing.

Plan for the possibility of an extended stay or unscheduled follow-up described in the consent. Identify work, caregiving, pet care, parking, and travel obligations that cannot move.

Read payment as a schedule

Separate screening, check-in, standby, dosing, confinement, outpatient, follow-up, travel reimbursement, and completion incentives. For FDA-regulated research, FDA guidance says compensation should accrue as participation progresses; ask how partial participation and investigator removal are handled.

Confirm payment method, processing time, card fees, tax documentation, and dispute contact. Keep a visit ledger.

Sources for this guide

Official guidance controls regulatory claims. Peer-reviewed research is identified when participant experience requires evidence beyond agency guidance. Links were checked September 5, 2026.

  1. U.S. Food and Drug Administration. Step 3: Clinical Research (opens in a new tab).
  2. National Institutes of Health. Clinical Research Trials and You: The Basics (opens in a new tab).
  3. U.S. Food and Drug Administration. Clinical Trial Participation (opens in a new tab).
  4. Secretary’s Advisory Committee on Human Research Protections (SACHRP), HHS. Addressing Ethical Concerns: Offers of Payment to Research Participants (opens in a new tab).
  5. Office for Human Research Protections. Questions to Ask About Volunteering for a Research Study (opens in a new tab).