Designing an informed consent process for a medical research study requires careful attention to clarity, ethics, and regulatory compliance. The goal is to ensure potential participants fully understand the study before deciding to join, without feeling pressured.

Here's a detailed design, including a plain language consent document and a robust process plan.

Informed Consent Process Design

Study Title: [Insert Study Title, e.g., "Understanding the Effect of 'Healthy Heart Pill' on Blood Pressure"]
Principal Investigator: [Insert PI's Name and Affiliation]
Sponsor (if applicable): [Insert Sponsor Name]

Part 1: Informed Consent Document (Plain Language - 8th Grade Reading Level)

This document is designed to be clear, concise, and easy to understand for someone with an 8th-grade reading level.

Consent Form to Join a Research Study

Study Title: [Insert Study Title - e.g., "Understanding the Effect of 'Healthy Heart Pill' on Blood Pressure"]

Principal Investigator: Dr. [Last Name], [Your Institution/University/Hospital]

Why are you getting this form?

We are asking you to be part of a research study. A research study is a way to learn new things. We hope to learn more about [mention disease/condition/intervention briefly].

This form tells you about the study. It explains:

• Why we are doing the study.


• What will happen to you if you join.


• The good things and bad things that might happen.


• Your rights as a participant.

Joining this study is completely up to you.

1. Why Are We Doing This Study? (Study Purpose)

We are doing this study to learn more about [briefly state the problem, e.g., "how to better manage high blood pressure"].

Specifically, we want to find out if a new medicine (let's call it the "Healthy Heart Pill") works better than a sugar pill (a placebo) or your usual blood pressure medicine. We want to see if the Healthy Heart Pill can lower blood pressure and keep it low, and if it is safe to use.

We hope what we learn from this study will help many people with high blood pressure in the future.

2. What Will Happen If I Join This Study? (Procedures and Duration)

If you decide to join this study, here's what will happen:

Before You Start (Screening Visit - about 1 hour):

• We will ask you some questions about your health.


• We will do a quick health check (like checking your blood pressure, heart rate, and weight).


• We will take a small amount of blood (like for a routine check-up). This helps us make sure you can safely join the study.

• Study Groups: You will be put into one of two or three groups by chance, like flipping a coin. You will have an equal chance of being in any group.


• Group 1: Will take the new "Healthy Heart Pill."


• Group 2: Will take a "sugar pill" (placebo) that has no medicine in it.


• Group 3 (if applicable): Will take your usual blood pressure medicine.


• Neither you nor the study team will know which group you are in. This helps us see the true effect of the medicine.


• Study Visits: You will come to the clinic for [e.g., 6] visits over [e.g., 6 months]. Each visit will take about [e.g., 30-60 minutes].


• At each visit, we will:


• Check your blood pressure and heart rate.


• Ask you how you are feeling and if you have had any problems.


• Sometimes, we will take a small amount of blood for tests.


• Give you your study medicine.


• Taking Your Medicine: You will take your study medicine every day at home as we tell you. We will ask you to keep a simple diary of when you take it.

3. What Are the Risks and Benefits of Joining?

Risks (Things that might bother you or be harmful):

Even though we will do our best to keep you safe, there are some risks to joining any study.

• From Study Procedures (like blood draws):


• You might feel a little pain, bruising, or lightheaded when we take blood.


• There is a very small chance of infection where the needle goes in.


• From the "Healthy Heart Pill" (or your usual medicine):


• The new medicine might cause side effects. Some common side effects of medicines like this can be: headache, dizziness, feeling tired, or an upset stomach.


• There could be more serious, but rare, side effects that we don't know about yet. We will tell you right away if we learn about any new serious risks.


• If you are in the sugar pill group, you will not be getting active medicine for your blood pressure for 6 months. This means your blood pressure might not be as well controlled during the study. We will monitor you closely and let you know if your blood pressure becomes too high.


• Privacy Risks: There is a small risk that your personal information could be seen by someone who shouldn't see it, even though we take many steps to protect your privacy.

• To you (Direct Benefits):


• You might feel better if the "Healthy Heart Pill" works for your blood pressure.


• You will get regular health checks and blood tests from our study team, which might help you understand your health better.


• You will not have to pay for the study medicine or study visits.


• To others (Societal Benefits):


• What we learn from this study could help doctors better treat people with high blood pressure in the future.


• It could help us understand if the "Healthy Heart Pill" is a safe and helpful new treatment option.

4. Can I Choose Not to Join, or Leave the Study Later? (Voluntary Participation and Right to Withdraw)

Yes, joining this study is completely your choice.

• You do not have to join if you don't want to.


• If you choose not to join, your regular medical care will not change, and no one will be upset with you.

• You don't need to give us a reason for leaving.


• If you leave, your regular medical care will not change, and no one will be upset with you.


• If you decide to leave, please tell the study team so we can make sure you stop the medicine safely and arrange for your regular doctor to take over your care.


• We will keep and use the information we have already collected from you up until the day you leave the study. No new information will be collected after you leave.

5. How Will My Information Be Kept Private? (Confidentiality and Data Security)

Keeping your personal information private is very important to us. Here's what we will do:

• Coded Information: We will use a special code number instead of your name on all your study records and samples. This code will only be linked to your name in a secure, password-protected file that only the study team can access.


• Secure Storage: All paper records with your name will be kept in locked cabinets. All electronic records will be stored on secure, password-protected computers with special encryption.


• Who Sees Your Information:


• Only the research team members will see your coded information.


• The [Institutional Review Board (IRB) / Research Ethics Board (REB)] – a group that checks if research is safe and ethical – may look at your records to make sure we are following the rules.


• Government agencies, like the [e.g., FDA in the US, Health Canada in Canada], may also look at your records to make sure the study is being done correctly.


• If the study results are published or shared, your name will never be used. We will only talk about groups of people, not individuals.


• HIPAA (Health Insurance Portability and Accountability Act) for US Participants:


• In the US, this law protects your health information. By signing this form, you are allowing us to use and share your health information for this research study as described above. You can take back this permission at any time by telling the study team in writing. However, if you take back your permission, we may not be able to collect new information, but we can still use the information we have already collected.

6. Will I Be Paid or Have to Pay for Anything? (Compensation)

• Compensation: You will be paid $50 for each completed study visit to thank you for your time and effort. This will be given to you at the end of each visit by a [e.g., gift card or check]. You could earn up to $300 if you complete all 6 visits.


• Travel Reimbursement: We will also pay for your travel costs to and from the clinic, up to $20 per visit. Please save your bus tickets or parking receipts.


• Study Costs: You will not have to pay for any study medicines, tests, or clinic visits that are part of this research. These costs are covered by the study sponsor.


• Taxes: Please know that any payments you receive might be considered taxable income. We will provide you with a tax form (like a 1099 form in the US) if you receive more than $600 in a year.

7. Who Can I Contact If I Have Questions?

• For Questions About the Study: If you have any questions about the study itself, your participation, or if you feel unwell during the study, please contact the Principal Investigator or a member of the study team:


• Dr. [Last Name] (Principal Investigator)


• Phone: [Insert Phone Number]


• Email: [Insert Email Address]


• Business Hours: [e.g., Monday – Friday, 9:00 AM – 5:00 PM]


• [Study Coordinator Name] (Study Coordinator)


• Phone: [Insert Phone Number]


• Email: [Insert Email Address]


• For Questions About Your Rights as a Research Participant: If you have questions about your rights as a research participant, or if you have concerns or complaints about the study, you can contact the [Institutional Review Board (IRB) / Research Ethics Board (REB)] at [Your Institution]:


• Phone: [IRB/REB Phone Number]


• Email: [IRB/REB Email Address]


• This is an independent group that reviews research studies to protect the rights and welfare of participants.

Your Agreement to Join the Study

• I have read this consent form.


• I have had a chance to ask questions, and my questions have been answered.


• I understand the risks and benefits of this study.


• I understand that my participation is voluntary and I can leave at any time.


• I agree to take part in this research study.

Participant Information:

Printed Name of Participant: _______________________________

Signature of Participant: __________________________________

Date: _________________________________________________

Person Obtaining Consent:

Printed Name of Person Obtaining Consent: ___________________

Signature of Person Obtaining Consent: ______________________

Date: _________________________________________________

Witness to Consent Process:
(A witness should be present if the participant is unable to read the form or for certain complex studies. The witness confirms that the information in the consent form was accurately explained to and apparently understood by the participant, and that consent was freely given.)

Printed Name of Witness: _______________________________

Signature of Witness: __________________________________

Date: _________________________________________________

Relationship to Participant (if any): _____________________ (e.g., None, Family Member)

Part 2: Informed Consent Process Plan

The document is only one part of informed consent. The process is crucial for ensuring true understanding and voluntary participation.

I. Pre-Consent Preparations:

• IRB/REB Approval: Ensure the entire study protocol, including this consent document and process, has been reviewed and approved by the Institutional Review Board (IRB) or Research Ethics Board (REB) before approaching any potential participants.


• Staff Training: All research staff involved in obtaining consent must be thoroughly trained on:


• The study protocol.


• The consent document's content.


• Ethical principles of research.


• Techniques for explaining complex information simply.


• The "teach-back" method (see below).


• Answering participant questions honestly and clearly.


• Recognizing signs of coercion or lack of understanding.


• Handling sensitive topics with empathy.


• Materials:


• Multiple copies of the approved consent form (paper or electronic access).


• A quiet, private, and comfortable space for the consent discussion.


• A comfortable chair, good lighting.


• Water/tissues if needed.


• Translation services/translated forms if a non-English speaking population is targeted.


• Initial Contact:


• When first contacting potential participants (e.g., by phone or in person), briefly explain the study's purpose and mention that more detailed information will be provided in a consent discussion.


• Schedule a dedicated appointment for the consent discussion, ensuring ample time (e.g., 30-60 minutes).


• Offer to send the consent form in advance (via mail or email) so they can read it at their leisure and prepare questions. Encourage them to bring a trusted family member or friend.

• Setting the Stage:


• Private & Quiet: Conduct the discussion in a private room free from interruptions, where the participant feels comfortable speaking openly.


• Introductions: The person obtaining consent (usually the PI or trained study coordinator) should introduce themselves and their role.


• Purpose of Meeting: Clearly state that the purpose of the meeting is to discuss the research study and answer any questions to help them decide if they want to participate. Emphasize that there is no pressure to join.


• Walking Through the Document:


• Do NOT just read the form aloud. Instead, use the form as a guide to verbally explain each section in simple, conversational language.


• Break Down Jargon: Re-explain any terms that might still be unclear despite the plain language.


• Pause and Ask: After explaining each major section (Purpose, Procedures, Risks, Benefits, Rights, etc.), pause and ask open-ended questions.


• "What questions do you have about what I just explained?"


• "Does that make sense?"


• "Is there anything I said that was unclear?"


• Checking for Understanding (Teach-Back Method):


• This is essential. Instead of asking "Do you understand?", which often elicits a "yes" even if understanding is limited, ask participants to explain key aspects in their own words:


• "Could you tell me in your own words what this study is trying to find out?" (Purpose)


• "If you decide to join, what are some of the things you'll be asked to do?" (Procedures)


• "What are some of the problems or side effects you might experience if you take the study medicine?" (Risks)


• "What are your options if you decide not to join this study?" (Voluntary Nature)


• "What would happen if you decided to leave the study early?" (Right to Withdraw)


• Listen carefully to their answers. If there are misunderstandings, re-explain and re-check until comprehension is satisfactory.


• Emphasize Key Elements:


• Voluntary Nature: Reiterate multiple times that participation is entirely voluntary and they can withdraw at any point without penalty.


• Right to Withdraw: Clearly explain the process for withdrawal and what happens to their data.


• Risks & Benefits: Ensure both are presented honestly and without exaggeration. Clarify that direct personal benefit is not guaranteed.


• Confidentiality: Explain the measures taken to protect their privacy.


• Contact Information: Point out where they can find contact information for questions or concerns about their rights.


• Addressing Questions:


• Encourage all questions, no matter how small.


• Answer truthfully and completely. If you don't know an answer, state that and offer to find out.


• Address concerns (e.g., time commitment, side effects, personal beliefs).


• No Pressure:


• State clearly: "You don't have to decide today. You can take this form home and think about it, or talk to your family."


• Offer to schedule a follow-up meeting if they need more time.


• Assure them that their choice will not affect their current or future medical care.

Once the participant confirms they understand the study, have had all their questions answered, and wish to participate, obtain their signature.

A. Electronic Signature Process (Recommended for Efficiency and Security):

• Platform: Utilize an IRB-approved, secure e-consent platform (e.g., REDCap's E-consent module, DocuSign for research, institutional e-signature systems).


• Guided Process: The research staff will guide the participant through the electronic consent process on a tablet or computer.


• On-Screen Presentation: The consent form will be presented clearly on the screen, often with features for scrolling, zooming, and highlighting.


• Comprehension Checks (Optional but Recommended): The platform may include short quizzes or "knowledge check" questions after key sections to confirm understanding before signing. This adds an extra layer of assurance.


• Electronic Signature: The participant will digitally sign by typing their name, clicking an "I agree" button, or using a stylus/finger to draw their signature, as guided by the platform.


• Date/Timestamp: The system automatically records the date and time of consent.


• Researcher Signature: The research staff will also electronically sign, confirming they conducted the informed consent discussion.


• Confirmation & Copy:


• The system should automatically generate a PDF copy of the signed consent form.


• This copy should be immediately emailed to the participant or printed out for them.


• Security & Audit Trail: E-consent platforms provide robust security, data encryption, and a detailed audit trail of when the document was accessed, signed, and by whom.


• Pros: Convenience, immediate delivery of copy, enhanced data security, improved legibility, automated version control, audit trail.


• Cons: Requires access to technology, potential digital literacy barriers for some participants, may require a physical presence to guide the process.

• Preparation: Print two identical copies of the IRB-approved consent form.


• Participant Signature: Once the participant confirms their understanding and willingness to participate, they will:


• Sign and date both copies of the consent form.


• Print their name clearly on both copies.


• Researcher Signature: The person who obtained consent will then:


• Sign and date both copies of the consent form.


• Print their name and role clearly on both copies.


• Witness Signature (if applicable): If a witness is required (e.g., for illiterate participants, or if deemed necessary by the IRB for complex studies), the witness will also sign and date both copies. The witness should be impartial (not part of the research team and not related to the participant unless specifically allowed by IRB for specific circumstances).


• Copy Distribution:


• Participant Copy: Provide one original signed copy to the participant to take home for their records.


• Study Copy: Retain the other original signed copy for the study records, stored securely.


• Storage: Store the study's original signed consent form in a locked cabinet in a secure location, separate from other study data if possible, or within a locked study binder.


• Pros: No technology required, familiar process for many.


• Cons: Paper management (printing, storage), risk of damage/loss, potential for illegible handwriting, no automated timestamp, less robust audit trail.

• Confirmation of Enrollment: Once consent is obtained, formally enroll the participant into the study according to the protocol.


• Ongoing Communication: Remind participants throughout the study that they can ask questions at any time and withdraw if they choose. Provide them with the contact information again at key points.


• Documentation: Document the consent process in the participant's study file, noting the date, time, who obtained consent, and any specific discussions or concerns.

This comprehensive design ensures that the informed consent process is ethical, transparent, and empowers potential participants to make truly informed decisions about joining the medical research study. Remember that this is a template and must be adapted to the specific details of your study and reviewed by your local IRB/REB.