Clinical Trials – Know the Facts about Protecting Research Study Participants like You

By Stephanie Pyle

As a cancer patient, carefully examining your options and discussing them at length with your doctor is important when considering a clinical trial for experimental treatment. Being a research volunteer plays a key role in improving the health of others in this country and around the world. By taking part in a research study, you make the important decision to help advance the scientific understanding of your health condition.

Throughout the study, a group of people known as an IRB will be keeping an eye on safety—so that your contribution is valued and treated with the respect it deserves.

What Is an IRB?

IRBs, or institutional review boards, protect the rights and welfare of research participants. Global research standards require clinical research involving human beings to be monitored by research ethics boards.

In the US, IRBs are diverse groups of people, including:

  • Scientists
  • Non-scientists
  • Doctors and nurses
  • Pharmacists
  • Researchers
  • Members of the clergy
  • Other community members.

IRBs must remain separate from the research they are reviewing. If an IRB member is somehow involved with a study the IRB is reviewing, that person cannot vote on whether to approve the study. This helps keep the IRB’s review unbiased and focused on the safety of study participants.

What Does an IRB Do?

1.       Before a study can officially start, the law requires that an IRB first review the study to make sure it is as safe as possible. The IRB also reviews any study-related material, like a TV ad promoting the study and a diary you might fill out during the study. Nothing misleading may be included that could pressure you into participating.

2.       IRBs also review the study’s informed consent form, or ICF. The ICF provides important information about what is being studied, potential risks and benefits you might experience, what happens at study visits, and other critical details. The ICF is there to help you make an informed decision about taking part in the study.

3.       The IRB needs to make sure you know that when you participate in a research study, you do not give up any of your rights. You are always free to leave a study at any time, for any reason.

4.       The IRB stays involved throughout the entire study. If researchers want to change the study, the IRB must first approve that change. If problems come up during the study, researchers must notify the IRB so IRB members can decide if the study should be changed to make it safer.

5.       At least once every twelve months, the IRB reviews the entire study to get a complete snapshot of what’s been happening. This information helps the IRB decide whether extra protections need to be added so the study continues to be as safe as possible for you and other participants.

How Do I Contact the IRB?

The IRB works for you, the study participant. If you ever have questions or concerns about the study that you want to discuss with someone outside of the research staff, contact your study’s IRB. Each ICF has the IRB’s contact information so you can easily call or write.

One of the most important parts of the IRB’s job is to talk with participants like you. The IRB will make sure your concerns are taken seriously.

IRB Oversight in Cancer Breakthroughs 2020

Announced in March 2016, Schulman IRB was selected to provide review services for the Cancer Breakthroughs 2020 QUILT program. Schulman IRB will be involved in every Cancer Breakthroughs 2020 trial, helping ensure that volunteers’ rights and safety consistently are protected across the entire program. Schulman IRB is one of the oldest central IRBs in the US, with more than 30 years’ experience overseeing practically every type of research.

Cancer Breakthroughs 2020 works with Schulman IRB because their members have extensive experience reviewing oncology research and are familiar with innovative cancer therapies. Some IRB members are cancer researchers, cancer treatment specialists, and some are even cancer survivors.

Schulman also uses cutting edge technology to support its review process. This makes the review process more efficient, so studies can start sooner and move faster. Cancer Breakthroughs 2020 is an ambitious initiative, which needs an IRB to keep pace with its goals without sacrificing participant safety. Rest assured, should you consider participating in the Cancer Breakthroughs 2020 QUILT program, your safety and protection is given the highest priority.

For More Information

The National Cancer Institute (NCI)’s booklet discusses taking part in cancer treatment research studies.

The Office of Human Research Protections (OHRP)’s brochure explains what research participation means.

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