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Research Participants Rights and Responsibilities

Welcome! It's important to understand your rights and responsibilities as a member of our community. Bluebonnet IRB aims to provide you with essential information that empowers you to make informed decisions and engage positively.  

Reasons for IRBs and Informed Consents

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What is a consent form?

The Informed Consent document contains the required information as found in and required by the United States regulations regarding the protection of human subjects (Code of Federal Regulations, Title 21, Part 50 Protection of Human Subjects). As required by this regulation, the informed consent must be reviewed and approved by an Institutional Review Board (IRB).

 

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a group of people that reviews research studies. The main goal of this review is to protect the rights and wellbeing of the human subjects participating in research studies.

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IRBs were established as the result of unfair treatment of human subjects. Prior to this, other committees existed as a requirement of the United States Public Health Service (USPHS) policy established in 1965. IRBs are regulated by the Food and Drug Administration and the Office for Human Research Protections (OHRP). The FDA and OHRP regulations require IRB review and approval of the study design (Protocol), Informed Consent form, and any recruiting materials prior to the enrollment of study subjects.

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What does an IRB mean to me?

The purpose of the IRB is to inform and protect human subjects through the information provided in the informed consent document. Therefore, the IRB is acting as a supporter for the research subject. This means that the IRB, during its review of the informed consent document, has the right and responsibility to ensure that the research subject is fully informed of the procedures involved in the study as well as the risks and other treatments that are available if participation in the study is refused.

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How can I tell that an IRB has reviewed and approved this study?

The date that Bluebonnet approved the study design as well as the information in the Informed Consent document is featured on the bottom of each page of the Informed Consent form.

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Bluebonnet, the IRB for this study

Bluebonnet is an independent Institutional Review Board (IRB) with a majority of its board members offering IRB services throughout the United States. Bluebonnet delivers nationwide services to research professionals.

According to FDA regulations, the committee must consist of at least five members from diverse backgrounds to ensure a thorough and adequate review of research activities.

To meet these requirements, the Bluebonnet Board includes members from various professions, including physicians, pharmacists, Ph.D. holders, nurses, clinical research professionals, and laypersons (non-scientific).

The contact number for the Subject Advocate is listed in the Contacts section of every informed consent document. Subjects may reach out to the Subject Advocate if they have any concerns about their rights.

Research Subject Bill of Rights

As a subject involved in an investigational research study, you have the following rights:

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  • Be informed of the nature and purpose of the experiment.

  • Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be used.

  • Be given a description of any attendant discomforts and risk reasonably to be expressed from the experiment.

  • Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.

  • Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits.

  • Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.

  • Be given an opportunity to ask any questions concerning the experiment or the procedures involved.

  • Be instructed that consent to participate in the medical experiment may be withdrawn at any time. The subject may discontinue participation in the medical experiment without prejudice.

  • Be given a copy of a signed and dated written consent form when one is required.

  • Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision.

Websites of Interest:

The Center for Information and Study on Clinical Research Participation: CISCRP

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National Cancer Institute (NCI) Website: Comprehensive Cancer Information - NCI

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Clinical Trials.gov: Home | ClinicalTrials.gov

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