Research Participants

Information

Are you, your friends, or family members participating in or considering participating in a clinical research trial? We have compiled some important links below to help you learn more about clinical research and our roles through the clinical trial. IRBco is an ethics review board responsible for protecting the rights and well-being of people who participate in research studies. We have been providing ethical review services since 1981. Please contact us by email or phone if you have any questions.
  • Becoming a Research Volunteer: It's Your Decision. The Office for Human Research Protections (OHRP) has launched a campaign to inform the general public about research participation.
  • Clinical trials.gov: ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.
  • National Cancer Institute: Clinical trials information from the US National Institutes of Health (NIH) National Cancer Institute
  • CISCRP: The Center for Information and Study on Clinical Research Participation (CISCRP) is a nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process.
  • Belmont Report: Ethical principles and guidelines for the protection of human subjects of research
  • Belmont Report Video OHRP also developed a video (9 minutes) that provides the context for the Belmont Report for those who are not familiar with its principles and uses.
  • The Nuremberg Code Directives for Human Experimentation
  • Declaration of Helsinki: World Medical Association, Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects

Informed consent process

The informed consent process in a clinical research trial is not just about signing a very long document. Informed consent explains the clinical study, procedures, risks and benefits, alternatives to participation etc. using simple and clear language. It is very important that you understand your rights as a research participant. Your participation in clinical research trial is voluntary and you have the right to withdraw from study at anytime during the clinical trial.

The Principal Investigator or any member of the study team should explain the consent process to you and help you make a decision about participating in study. You have the right to ask questions or raise concerns before, after or anytime during the clinical trial.

In general, the following are integrated parts of an informed consent in clinical trials:

  • A statement that the study involves research.
  • An explanation of the purpose of the study.
  • The expected duration of the study and the subject's participation in the study.
  • A description of the procedures to be followed.
  • A description of any reasonably forseable risks or discomforts of the subject.
  • A description of any benefits, to the subject or to others, which may be reasonably expected.
  • An explanation of the purpose of the study.
  • The expected duration of the study and the subject’s participation in the study.
  • An identification or any procedures that are experimental. A disclosure of alternative procedures or courses of treatment that might be advantageous to the subject.
  • A description of the confidentiality of records that identify the subject, and a disclosure that records may be made available to the FDA, study sponsors and IRB.
  • An explanation of medical treatments and any compensation that may be available, should any injury result from the research.
  • An explanation of whom to ask for information about the research or subjects’ rights, and whom to contact in the event of a research-related injury to the subject.
  • A statement that participation is voluntary and that the right to refuse to participate in the study or leave the study exists without affecting the quality of medical care the subject would otherwise receive.
 
 

Awards

IRBco is awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP). Accreditation validates our comprehensive program which integrates ethical reviews, state-of-the-art technology and staff development to create an environment of responsible and ethical human subject protection. We provide our services at levels beyond client expectations and that exceed federal requirements for safeguarding participants. We believe that accreditation leads to an increased level of professional accountability.

 
 
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