Skip to main content

Mood Guide

Find clear information about services, treatments, research, and practical next steps.

Mood Guide provides general information from this website. It is not medical advice. Do not enter personal health information.
Safety Ask Results

No personal health details.

Resources

Research Participants

Informed-consent support during research visits

Coordinators prepare consent materials and give you time to read, while the investigator explains the study and you decide whether participation is right for you.

Content

Lisa Harding MD and Mood Institute featured on Bloomberg Television · Credit: Bloomberg Television

Informed consent is more than signing a form. It is a conversation and a document that explain a research study so you can decide whether participation is right for you. You should have time to read the materials, ask questions, and consider the information before making your own decision about whether to take part.

Research staff may prepare consent materials, make sure you have time to review them, and support documentation of the consent process within assigned responsibilities. The investigator explains the study's purpose, procedures, risks, and alternatives. Operational support can make materials and timing easier to manage, while the investigator provides the study explanation needed for informed decision-making.

Bring questions that help you understand the practical experience. You might ask: 'What happens at each visit?' 'What would I be asked to do?' 'What are the possible risks?' 'What alternatives are available?' 'Who should I contact later with a question?' and 'Will I receive a copy of the consent document?' Ask for clarification if any part is unfamiliar.

You can take the time you need to decide, ask for more explanation, or decline participation. Research consent is separate from routine clinic registration. Signing should follow the approved study process and your voluntary decision, without pressure from staff. Consent does not establish study eligibility; that determination follows required screening and investigator-led review.

Before a consent discussion, set aside time to read without rushing and write down questions you want answered. If the research team requests information or records, ask for the appropriate secure channel rather than placing them in Mood Guide or general contact fields. Ask when the consent discussion will occur and who will explain the study procedures.

It can help to separate questions about the study itself from questions about visit logistics. Write down anything you want explained about procedures, risks, alternatives, timing, transportation, or future contacts. Bring that list to the conversation, and ask who can answer each question. A written list can make it easier to revisit details after you have had time to consider them.

Sources: FDA — Informed Consent guidanceNIH — Clinical Research Trials and You

Contact Mood Institute

Ready to continue the conversation?