Fillable Form Research Informed Consent

What is a Research Informed Consent form?

A Research Informed Consent form is a document used to convey voluntary participation in research or investigation.

It is often used in clinical trials and other high-risk studies where potential participants are subject to highly competent decision-making.

How to fill out a Research Informed Consent form?

Page 1

Consent form version date

Enter the consent form version date.

Title

Enter the title of the research or investigation.

Principal Investigator

Enter the principal investigator’s name.

Department

Enter the principal investigator’s department.

Address

Enter the principal investigator’s address.

Phone

Enter the principal investigator’s phone number.

Email

Enter the principal investigator’s email.

Co-Investigator/Faculty Sponsor

Enter the name of the co-investigator or faculty sponsor.

Department

Enter the department of the co-investigator or faculty sponsor.

Phone

Enter the phone number of the co-investigator or faculty sponsor.

Email

Enter the email of the co-investigator or faculty sponsor.

Co-Investigator

Enter the name of the co-investigator.

Department

Enter the department of the co-investigator.

Phone

Enter the phone number of the co-investigator.

Email

Enter the email of the co-investigator.

Research Staff

Enter the name of the research staff.

Phone

Enter the phone number of the research staff.

Email

Enter the email of the research staff.

WHAT IS THE PURPOSE OF THIS RESEARCH

Enter the purpose of the research.

Approximately

Enter the approximate number of participants.

Participants will be included at

Enter the study where the given approximate number of participants are included.

HOW LONG WILL I BE IN THIS RESEARCH

A week

Mark the box if you will be participating in the research for a week or five business days.

A month

Mark the box if you will be participating in the research for a month or twenty business days.

Others

Mark the box if you have other options and enter the details.

Page 2

Consent form version date

Enter the consent form version date.

WHAT WILL HAPPEN IN THIS RESEARCH?

Enter all expectations regarding the research.

WHAT ARE THE RISKS OR DISCOMFORTS INVOLVED IN THE RESEARCH?

Enter the risks and discomforts involved in the research.

ARE THERE ANY BENEFITS TO PARTICIPATION?

Enter the benefits if participants will be given compensation for their participation.

ARE THERE ANY ALTERNATIVES TO PARTICIPATION?

If yes, enter the alternatives to participation.

Note: An alternative is to not participate.

WILL MY INFORMATION BE PRIVATE?

Enter Yes, if the participant’s information will be in private. If No, enter specific data or explanation as to why the information is needed for publication.

Page 3

Consent form version date

Enter the consent form version date.

WHAT WILL HAPPEN IF I AM HURT OR INJURED?

This section is to be filled with the researcher or investigator.

Box 1

Mark the box if you will be assisting the participant in obtaining appropriate attention (not paying for all the expenses) when complications arise as a direct result of participation in the study.

Will not pay

Enter the name of the research company.

File against

Enter the name of the research company.

Please contact

Enter the name of the legal counsel, in events where participants want to file a complaint against the research company.

At

Enter the legal counsel’s contact information.

Box 2

Mark the box if you will cover all the participant’s expenses when complications arise as a direct result of participation in the study.

Paid by

Enter the name of the payor.

DO I HAVE TO PARTICIPATE?

Participating in any study or investigation is completely optional. Participants must know their rights to emancipate from the study.

WILL I BE TOLD ABOUT THE STUDY RESULTS?

This section must be filled with the researcher or investigator.

Box 1

Mark the box if you will contact the participant regarding the result of the study.

Box 2

Mark the box if you will not contact the participant regarding the result of the study.

Reason

If not, enter the reason.

WILL IT COST ME ANYTHING TO PARTICIPATE?

Box 1

Mark the box if the participant will be spending anything to participate in the study.

Amount

If yes, enter the amount.

Box 2

Mark the box if the participant will not be spending anything to participate in the study.

Page 4

Consent form version date

Enter the consent form version date.

WILL I BE PAID FOR MY PARTICIPATION IN THE RESEARCH?

Box 1

Mark the box if the participant will be paid for participating in the study.

Amount

If yes, enter the amount.

Box 2

Mark the box if the participant will not be paid for participating in the study.

WHAT IF I HAVE QUESTIONS REGARDING THIS STUDY?

TIP:

For participants, always ask when in doubt. Even after you have decided to participate in the study, asking for clarifications and explanations will give you new insights on whether to continue or not.

Contact

Enter the name of the researcher in case the participant raises some questions regarding the study.

Phone

Enter the phone number of the researcher who is responsible for answering the participant’s inquiries regarding the study.

Email

Enter the email of the researcher who is responsible for answering the participant’s inquiries regarding the study.

Located at

Enter the address of the researcher who is responsible for answering the participant’s inquiries regarding the study.

Contact

Enter the name of the individual responsible for answering the participant’s inquiries regarding their rights in the study.

Phone

Enter the phone number of the individual responsible for answering the participants’ inquiries regarding their rights in the study.

Email

Enter the email of the individual responsible for answering the participants’ inquiries regarding their rights in the study.

Located at

Enter the address of the individual responsible for answering the participants’ inquiries regarding their rights in the study.

CONSENT TO PARTICIPATE

Enter the individual or organization’s name approving the Research Informed Consent form for the study.

Name of Participant

Enter the participant’s name.

Date

Enter the date.

Signature of Participant

Enter the participant’s signature.

Date

Enter the date when the participant has signed the Research Informed Consent.

Signature of Investigator

Enter the investigator’s signature.

Date

Enter the date when the investigator has signed the Research Informed Consent.

What is the purpose of a Research Informed Consent form?

The main purpose of a Research Informed Consent form is manifesting the unforced agreement between a researcher and a participant. It shows that the participant has given informed consent to engage in the study.

Obtaining a Research Informed Consent also implies that:

1. The participant decided without coercive measures or undue influence;
2. The participant was given a chance to ask questions regarding the study;
3. The participant has a thorough understanding of the objective of the study;
4. The researcher provided sufficient information and answered the participant’s sentiments regarding the study; and
5. The researcher provided information that complemented the literacy of the participant.