For study participants, especially those with complex illnesses, “protected” does not mean “risk-free”—all studies carry some risk. Some of the principles that protect study participants include the following: study organizers identify risks, they inform potential study participants of the risks, and they formalize a risk-management plan.
Some of the protections for study participants include (but are not limited to):
- Knowing what will happen during a study—Study protocols. A study protocol is a document that describes in detail the plan for conducting a clinical study.
- Federal regulations define study protocol contents, particularly if the study involves investigational (not FDA approved) products.
- Clinical studies are designed to include a listing of the characteristics that allow a person to participate called the “eligibility criteria.”
- Studies also schedule relevant procedures and evaluations for participants often enough so that potential risks can be detected and addressed in a timely manner.
- Study participants also have specific contact information so that they can get in touch with someone related to the study for any reason at any time.
- Knowing the possible risks and benefits of participating—Study participation consent process. One of the primary safeguards for study participants is that they are informed about the potential risks, benefits, alternatives, and responsibilities of the clinical trial before they agree to participate. When a potential study participant understands the risks, alternatives, and responsibilities, he or she formalizes the decision to participate by communicating with the study investigator or representative and by documenting the agreement in writing. The interactive process of receiving information, asking questions, and indicating agreement is known as the consent process.
- Reviewing the study before it begins—Institutional Review Boards (IRBs). An IRB is an independent body authorized by federal regulations to evaluate a clinical research study to ensure ethics and safety. The IRB reviews the study protocol at length. At the federal level, the Office for Human Research Protection regulates IRBs and ensures that they meet criteria for IRBs as described in federal regulations.
- IRBs review study protocols and the documents used to obtain consent from study participants to ensure that potential risks are clearly stated, and that investigators take sufficient and appropriate measures to address risks before the study can proceed.
- If a study protocol uses a product regulated by the Food and Drug Administration (FDA), then the FDA may also review the protocol and has the option to request changes before the study can proceed. In some cases the FDA may waive the requirement for an IRB to approve a study. IRBs that review FDA-regulated research must follow Title 21, Part 50 of the CFR.
- Monitoring the study while it is underway—Data and Safety Monitoring Committee. Some studies rely on an additional independent committee to monitor the study results and its conduct while the trial is underway. Such an independent chartered committee is known as a Data and Safety Monitoring Committee (DSMC) or Data and Safety and Monitoring Board (DSMB) or Data Monitoring Committee (DMC). The functions and oversight of such committees are distinct and independent from IRB activities and approvals. The NICHD has its own Data Safety and Monitoring Policy which outlines the Institute's expectations for this type of clinical research activity.
- Protecting privacy—Certificates of Confidentiality. In general, confidentiality of study participants is covered under the Health Insurance Portability and Accountability Act. In addition, if the release of study data could have negative consequences if linked to a certain participant, due to the nature of the disease or condition, the study can receive a Certificate of Confidentiality. A Certificate of Confidentiality is issued by the NIH, and is a legal document that protects investigators and institutions from being compelled to reveal information that would identify research participants.
- Ensuring ethical conduct and scientific quality—Good Clinical Practices.
- International policies. International ethical and scientific quality documents, such as the Good Clinical Practices, created by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, provide further protection for those who take part in clinical studies. Such standards are agreed to by regulatory agencies in the United States, Europe, Japan, and other countries to provide general guidance for assuring that participants in clinical research are respected and protected.
- FDA Good Clinical Practice Guidelines. The Food and Drug Administration (FDA) has developed guidelines related to good clinical practices. Guidances, Information Sheets, and Important Notices on Good Clinical Practice
This information sourced from : http://www.nichd.nih.gov/