What is an IRB?

The U.S. Code of Federal Regulations addresses the protection of human subjects participating in clinical research, and outlines the role of an institutional review board (IRB). An IRB reviews research studies to assess safety, privacy and confidentiality concerns as they relate to the research that is being considered. The IRB also determines what information should be provided to the potential research participant and approves the consent document that is to be used before the study is started. The IRB can approve or modify studies to ensure that they include proper protections, or disapprove any study that poses excess risk to a research participant. The main purpose of the IRB is to protect the rights and welfare of research participants who participate in research studies.

Who serves on an IRB?

According to the regulations, an IRB should have at least five members with varying backgrounds to ensure a sufficient review of the research studies. The IRB members are qualified based on their experience and expertise and the IRB should be diverse in terms of race, gender and cultural backgrounds. The IRB should also have at least one member who has scientific expertise and at least one member who does not have a scientific background.

What does an IRB review?

The IRB reviews research studies involving human subjects to ensure that the risks are appropriate in relation to the benefits and that there are safeguards in place to address risks encountered in the research. The regulations require an IRB to specifically review various aspects of a research study such as the study design, risk vs. benefit, the informed consent document and process, privacy protection and confidentiality.

About Chesapeake IRB

How often does your IRB meet?

Our IRB meets five times a week (Monday, Tuesday, Wednesday, Thursday and Friday) excepting holidays.

What type of research and therapeutic areas can your IRB review?

Our IRB oversight has included all phases of clinical research including Phase I-IV IND studies, IDE studies, NIH/federally funded research, social science and behavioral studies, registry studies, retrospective chart reviews and investigator initiated studies.

Are there deadlines for submissions?

There are no deadlines for submissions.

What is the review timeline for submission of a new protocol?

Once your submission is complete, IRB review will occur within five business days. You will receive the IRB’s determination within one to two business days following the review.

What is the review timeline for submission of an additional investigator for a previously approved protocol?

An investigator’s submission is reviewed within 24 hours upon receipt of a complete submission. You can expect the outcome of the review within one to two days after that.

Does Chesapeake IRB require qualifications of sub-investigators and personnel involved in the informed consent process plus the respective 1572 (if applicable) to be submitted?

No. Chesapeake only requires information on the principal investigator of the study and does not need the 1572 document (if applicable).

What documents are needed for initial site submissions?

A site application needs to be completed through our 21 CFR Part 11 compliant CIRBI website at CIRBI.net. In the application, there will be areas where you can upload attachments, including the CV of the principal investigator and any FDA findings within the past five years that are required as part of the submission. There are other places where you can upload SOPs, site-specific informed consent form language and any other supporting document that may aid in the IRB’s review.

What are the costs associated with IRB review?

Please request a fee schedule on the contact us page.

How are investigators, CROs and sponsors informed of approvals or requests by the IRB?

Any time approval information is posted or there are additional requests from the IRB, you will be prompted by email notifications sent from our CIRBI website.

Will the IRB provide hard copies of documents?

No. All IRB documentation is electronically available through our 21 CRF Part 11 compliant CIRBI website at CIRBI.net.

How do I submit information to Chesapeake IRB?

Chesapeake IRB is a paperless IRB. All submissions, from the beginning of the study to the termination of a study, need to occur through our 21 CFR Part 11 compliant CIRBI website at CIRBI.net.

Do I have a point of contact for my study?

Yes. Chesapeake IRB has a dedicated project coordinator assigned to all your studies to ensure that any questions you have are rapidly addressed.

Does Chesapeake IRB provide translation services?

Yes. Chesapeake IRB can assist with certified translation using our approved vendor, or we can accept a valid certificate of translation. Please contact us for additional information.

Where do I go if I have questions about your online submission management system, CIRBI?

Please see get started or contact us.

Chesapeake IRB Accreditation and Compliance

Has your IRB ever been audited by the FDA, OHRP or any other government agency?

Chesapeake IRB has been audited by the FDA five times: 1998, 2000, 2004, 2009 and 2014. There were no significant findings in any of the audits and no FDA 483s were issued.

Is your IRB accredited?

Yes. Chesapeake IRB is the only independent IRB to receive full accreditation simultaneously from both the Association for the Accreditation of Human Research Protections Programs (AAHRPP) and Partnership for Human Research Protection (PHRP). (As of today, only AAHRPP exists). Chesapeake IRB also received full re-accreditation in 2010 and 2015 without any delays. This seal re-affirms our commitment to excellence to the subjects participating in research and to our clients for whom we serve as a risk management partner.

Is Chesapeake IRB registered with the Office for Human Research Protections and FDA?

Yes. Chesapeake’s registration number is 00000790.

Why Participate in Clinical Research?

What is a clinical study? Why are studies done?

Before a new medicine can be used by study participants, their doctors must understand:

  • What disease the medicine treats
  • How much better participants can expect to get
  • How soon they may feel better

They must know things like whether two medicines for different diseases can be taken at the same time or if they can cause medical problems and shouldn’t be taken together. Most importantly, they must know that the medicine is safe for the intended participants. Clinical research studies help answer these questions and others. Clinical studies are a necessary step toward making new medicines and treatments for all of us.

How are they organized?

Clinical studies are done in steps or phases. Each phase looks at different questions:

  • In Phase I studies, the study medicine is administered to people for the first time. Only a small number of people (usually between 20 and 80) are part of Phase I studies. Phase I studies focus on the safety of the study medicine and how much medicine may be safe to take in future studies.
  • In Phase II studies, study doctors begin to look at the effect of the study medicine on disease and continue to study its safety. Usually between 100 and 300 people are in a Phase II study.
  • Phase III studies are done to better understand the effectiveness and safety of the study medicine or treatment. Phase III studies include large groups of people (1,000 to 3,000 – or even more) so that doctors can have a thorough understanding of the study medicine.
  • Phase IV studies are done with medicines or treatments that can be prescribed for patients. Phase IV studies are done for many reasons, including to find out more about the safety of the medicine or to see how it works for other diseases.

How are study participants protected?

Clinical studies and the study doctors who work in them are regulated by the U.S. government. The law requires that every study be reviewed by an independent group of scientists and community members, whose job is to make sure that the study is as safe for the volunteers as possible. This group is called an institutional review board or IRB.

You might consider volunteering for an IRB — these boards need community members and always need help to review studies. The IRB looks at the plan for the study (called the research protocol) before anyone can join the study. They may ask for changes in the study to make it safer for the people who participate. The IRB also looks at the participants’ confidentiality and privacy. If you join a study, your name and contact information will be carefully guarded. Your information will not be in any of the reports about the study. If new information that may be important to you and your decision about the study, especially information about safety, is discovered during the research, you will be informed.

Why join a study?

People have many reasons for joining a study. Some people like the feeling that, by joining, they are helping new medicines to become available for all. They may feel that they are helping to improve medical care for the next generation. Many studies include health education and medical tests, which some people particularly like to have and join a study for this reason. Some studies need participants who are suffering from a particular disease or condition. In these cases, these people often participate hoping to find a better treatment.

Remember, your confidentiality and privacy will be carefully guarded by the study. Your name will not be in any reports about the study.

What are the risks?

A study medicine is an untested medicine. Clinical studies are done to test the study medicine or treatment. It is important to talk to your doctor and the study doctor about the study. Ask them what is known and what risks they see. And, when you have asked them all your questions, ask them what else you should ask.

All medicines have unpleasant side effects. Some people may experience the side effects, and others may not. Ask the study doctor about the kinds of side effects that may happen in the study.

The study likely will require appointments with the study doctor. Make sure that the schedule is convenient for you. If it isn’t convenient, ask the study doctor if it can be more flexible. These appointments are important for checking the effects of the study medicine on your health. Additionally, some studies may require overnight stays. Rest assured, researchers are required by law to tell you all about what is required before you agree to participate.

What are placebos?

A placebo is an inactive substance. Studies use placebos to compare with a drug or treatment to check the effectiveness of that drug or treatment.

How do I decide?

Talk with the study doctor and with your own doctor. Ask the study doctor to explain the study — including any details you would like to know. Feel free to ask all your questions. The study staff want you to feel comfortable with the study. Here are some questions you may want to ask:

  • What will I have to do in the study?
  • How long will it last?
  • How many times will I have to come for study appointments?
  • How long will the study appointments last?
  • Who will be watching out for my health?
  • What are the risks in the study?
  • Will my transportation and parking be reimbursed?

Again, once you have asked every question you have, ask the study doctor what else you
should ask.

What is “informed consent”?

The U.S. government oversees medical studies that include people. One law ensures that no person can be forced to be in a clinical study or join against his or her will. Another law requires researchers to make sure that the people who join understand what to expect. Any person who joins a research study must “consent” to join, and that consent must be “informed.”

The study staff or doctor will give you an Informed Consent Form to explain the study. Please take your time to read it and understand it, and be sure to ask about anything you don’t understand. If you like, you may take it home and have a family member or your doctor look at the form. If you decide to join the study, the study staff or doctor will ask you to sign the form to show that you understand what has been explained about the study. You will also be given a copy of the Informed Consent Form to take home and keep.

Responsibilities

Everyone who joins a clinical study has responsibilities to the study. These are some of the important responsibilities that study volunteers have:

  • Come to the study appointments on time. If you have a conflict, please call and reschedule.
  • You may be asked to take a medication or fill out forms at home. Please try to do this on schedule and follow the study doctor’s instructions.
  • Always try to be honest when answering questions. If you had a headache, it is important for the study staff to know. If you don’t feel better, tell them. They want to know the truth. Ask the study staff what other responsibilities you may have in the study.

Rights

Everyone who joins a clinical study has rights. Ask the study staff about your rights in the study. The Informed Consent Form will also tell you about your rights. Some important rights are:

  • You do not have to join a study.
  • If you join, you can change your mind. You may leave a study at any time.
  • You have a right to ask questions and have them answered to your satisfaction.
  • You will not be charged for being in the study. Some studies reimburse volunteers for their time and transportation costs.
  • You have a right to confidentiality and privacy. Your name and contact information will not be on any study report.

You may have questions about a specific study, an injury that you think might be related to research, the instructions you received or a payment. Ask the study doctor or staff all your questions. If you have questions about your rights, or if you have complaints, you can also contact the IRB listed on your copy of the Informed Consent Form.

How do I learn more?

Below are links you can visit for more information about clinical studies:

  • The Center for Information and Study on Clinical Research Participation is a nonprofit organization that works to help the public understand clinical research. ciscrp.org
  • CenterWatch is a company that works to educate study participants about clinical research. centerwatch.com

To find lists of U.S. clinical research studies:

  • Clinical studies are listed on a website run by the U.S. government. You can use this site to find a study. clinicaltrials.gov
  • The National Cancer Institute lists cancer studies on its site. cancer.gov/clinicaltrials
  • The U.S. Department of Veterans Affairs also works to educate veterans about clinical studies. research.va.gov/default.cfm
  • The National Health Council is a group that works to improve health across the country. Its membership represents a breadth of disease-specific participant advocacy groups. nationalhealthcouncil.org

To find lists of Canadian clinical research studies:

Most medical schools offer information on clinical studies. You can also find information about research studies by searching the web for the participant support groups that meet your specific needs.

Pediatric and Adolescent Research

Can a child join a study?

Yes. Children can join studies, and they have an important role to help improve health care.

In 1960, only 20 percent of children with cancer survived. Now, because of the medicines that have since been discovered and studied, more than 85 percent of children who get cancer recover and go on to live a normal adult life. More than half of children with cancer in the United States enroll in at least one clinical research study.

What should I do if someone asks me to consider a study for my child?

Talk to your child’s doctor. No one knows your child’s health better than his or her doctor. If your child’s doctor is not the study doctor, he or she may want to consult with the study doctor. Get all the information you need to help you decide whether the study may be a good idea for your child.

Where do I go if I am looking for a study for my child?

Ask your doctor. Search the internet. If your child has a chronic or serious disease, ask the support group for that disease.

Will my child be safe in a study?

Government regulations require that studies including children receive special scrutiny. The IRB will carefully evaluate a study of children to see that it is as safe as it can be.

What else should I consider?

Ask your child. Explain the reasons for the study and what he or she will have to do. If you have questions, ask the study doctor, and ask him or her to speak with both you and your child. If your child doesn’t want to be in the study, don’t try to persuade him or her. No one ever should feel forced to join a study — including your child.