The Human Research Protection Program (HRPP) at WMed is committed to the protection of the rights and welfare of individuals who volunteer for research. Volunteers are also known as "subjects" or "participants." This webpage includes basic information about research and the rights of research participants.
- What is research?
- Research is a study that is done to answer a question
- Scientists and Doctors do research because they don’t know for sure what works best to help you.
- Some other words that describe research are clinical trial, protocol, survey, or experiment.
- Research is not the same as treatment.
The faculty, students and staff at WMed conduct research in many different areas.
People might participate in research that is being done to learn more about:
- how or why an illness occurs or spreads
- what treatments work best for an illness
- how people behave or make decisions
- the ways groups and societies are organized
- what people think or believe
- how people learn
- the best ways to provide social services or healthcare
- What is an Institutional Review Board (IRB)?
An Institutional Review Board (IRB) is a group of people that are not part of the research study team. These include specially trained doctors, scientists, and other people from the local community. An IRB reviews the research plan to make sure people in the research study will be treated fairly and that any risks will be explained to them.
Before a study can begin, the research plan must be approved by an IRB. You can reach the WMed IRB by calling 269.337.4345 or use the website irb@wmed.edu if you have questions, concerns, or complaints. The WMed IRB oversees research at the WMed offices, Bronson Hospital and Ascension Borgess.
- What is a clinical trial?
A clinical trial is a strictly controlled research study conducted in people. Each study is carefully designed to answer specific questions about a new treatment or a drug or a medical device to make sure it is safe and effective to use in people.
The details of the clinical trial, including all the tests and procedures used in the study, are outlined in a research plan, also called a protocol. The doctors, nurses and scientists who run the clinical trial must follow the protocol and run the tests according to the strict rules set by the Food and Drug Administration (FDA) and other government agencies. The rules ensure that people who participate in the clinical trial are treated as safely as possible.
- How does a clinical trial work?
In clinical trials, investigational drugs are often compared with approved drugs or placebo (pill, liquid, or powder that does not have any drugs or medicine) to assess if it is safe or effective. Clinical study participants may be assigned to take:
- Investigational drugs
- Approved drugs
- Placebo
- Any combination of the above
A placebo is a product that does not have any drugs or medicine. The participant, physician, and research staff may not know which participant receives a placebo or which receives the investigational treatment. Not knowing which participants are receiving the actual treatment allows the physician and research staff to impartially observe the participants during the study. Regardless of which treatment participants receive, the level of medical attention and care that each receives is the same.A drug or device is considered "experimental" because the U.S. Food and Drug Administration (FDA) has not approved it for any use, or to treat a certain illness.
As a research participant, you may be asked to:
- Take investigational drugs as directed
- Come in for your office visits
- Have laboratory and diagnostic tests
- How are my rights protected if I volunteer to participate in a clinical trial?
As a participant in a research trial, protecting your rights is one of the most important jobs a researcher has.
Before you enter a trial, you have the right to be given all the information you need to make an informed decision about being in the study. Some example of what you must be told are:
- Why the study is being done
- Your option to withdraw from the study at any time without any penalty and without having to give a reason
- What is expected of you
- What will be done to you for research reasons
- How long you will be in the study
- The bad and good things that could happen to you in the study
You have the right to be given all information in words that you understand.You also have the right to be given as much time as you need to make your decision.
Another right you have is to ASK QUESTIONS and have a detailed talk about the study with the person asking you to volunteer. That is what helps you make an informed decision about whether to be in a study, or continue once you have said yes. You may ask as many questions as you like, as many times as you like, to make sure you understand what is being told to you. The person who is asking you to be in the study may also ask questions to make sure you
Research participants are encouraged to share their concerns or complaints regarding their involvement in a research study with the investigator or study staff. However, research participants may also report their concerns. To report a concern or complaint to the WMed HRPP click here.
- Where can I find research opportunities for myself or others in the Kalamazoo area?
- WMed Center for Clinical Research (Currently Enrolling Clinical Trials)
- Kalamazoo Community-based Participatory Research
- Cancer Research Consortium of West Michigan
- ClinicalTrials.gov (a federal government-run registry that lists many clinical trials conducted in the US and around the world. It is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of disease and conditions.)
- Ask your healthcare providers if they are doing research, or if they might be able to refer you to another researcher or to other sources of information.
- Advocacy groups, interest groups or social organizations often work with researchers who are looking for people with certain characteristics, with a particular disease or from a specific community or group of people.
- Searchclinicaltrials.org (a website run by a non-profit organization called Center for Information and Study on Clinical Research Participation [CISCRP])
- The clinical trials website of the National Cancer Institute (listings and information).
- Subjects may be contacted about research study opportunities by their health care provider, a research study coordinator or a research team member via phone or letter. Subjects may also contact WMed directly if responding to radio, television, or newspaper ads or other types of recruitment material.
- What will happen if I volunteer for research at WMed
You will be presented with information about the study. This is called the informed consent process. Members of the study team, including the researchers, will discuss this information with you. They will usually ask questions to make sure that you understand the information that was discussed.
Once you understand the information and choose to participate, you will be asked to sign the consent form. You might also be asked to sign other documents, such as a form giving permission to use your medical records (HIPAA Authorization).
After you sign the informed consent, the researchers may need to ask some basic questions or perform procedures to make sure you qualify to participate. If you participate in medical research, this may include a physical examination, blood tests or other procedures. This part of the research is called "screening".
Even if you give informed consent, you are not guaranteed a place in the research study. In some cases, researchers can accept anyone who volunteers. In other cases, researchers can accept only a certain number of people or only people who meet the study requirements (inclusion/exclusion criteria).
If you do not qualify, it does not mean something is wrong with you. It just means that you did not meet the study requirements. There might be other studies in which you would qualify to participate.
If you qualify for a study, you will go through the exact steps of the approved research plan. What you undergo during the research should be exactly what is described in the consent form.
What will happen (and for how long) depends on the goals of the research. Sometimes researchers will be able to work around your schedule. In other studies, visits might have to happen at very specific times. All of this should be explained to you during the informed consent process.
- Will I be paid for participating in research?
Payment will be explained to you during the informed consent process. Some studies do not have the resources to pay you. Other studies might pay you for the time and effort it takes to participate. The money is usually only enough to cover expenses (parking, transportation, meals, etc.) and maybe for some of the time you spend away from work.
The payment should not be significant enough to convince you to take risks that you normally would not take.
If you leave before the end of the research, you will usually be paid for that portion of the research you completed.
- What happens when the study ends?
When you complete the study (or if you choose to leave the study early), that is usually the end of your participation except for the possible safety follow-up visit(s). The consent form might describe extra contact(s) by the study team after the study visits have concluded. The researcher might send you information about your participation, including any new information that becomes available that may affect your health. If you were taking an experimental drug, sometimes you may be able to continue taking the drug. You might be asked if you are willing to be contacted about other research in the future.
At the end of the study, the researchers put together all the information they have collected. They will analyze that information. They might be able to publish the results in scientific journals, present the results at conferences and use the results to get grants for more research. Your personal health information will not be included in the resulting publication(s) or presentation(s).
Sometimes the WMed study information will be combined with information from other research sites involved in the study. For an industry-sponsored study, the company who paid for the research may use the information to help get a product approved by the U.S. Food and Drug Administration.
Researchers may or may not be in the position to provide study results at the end of the study. Sometimes it takes many years to achieve study results. You should ask the study investigator about this before you enroll.
Reporting Research Concerns and Complaints
The HRPP is concerned about the safety, rights and welfare of all individuals participating in research projects at the medical school and its affiliated sites. We take all research concerns or complaints very seriously.
To resolve minor research concerns or complaints, you may prefer to speak directly with the study investigators and/or their staff. We understand that you may not wish to speak with the study investigator directly in some circumstances. We can help you whether you wish to speak with the study investigator or not.
If you have a research-related concern or complaint that we may be able to help resolve, contact our office as soon as you can.
- How to report a concern or complaint
To help us handle your report, please provide as much information as possible using one of the reporting methods suggested below. You can use our optional Reporting Form for Research Concerns or Complaints. Even if you do not wish to use the Reporting Form, you may still find it to be a helpful tool as you prepare to contact us.
- Making a phone report
You may report your concern or complaint by phone by calling the HRPP at 269-337-4269. In order to assure that we clearly understand your concern or complaint, we may encourage you to follow up your phone call with a written report in some circumstances.
- Completing the optional reporting form for research concerns or complaints
Please complete all of the sections of the Reporting Form for Research Concerns or Complaints with as much information as you feel comfortable providing. If you have questions about this form, or need assistance in completing the form, please call the HRPP at 269-337-4269. You may also contact us by email at IRB@wmed.edu.
- How we respond
The HRPP Director handles the research concerns or complaints that we receive. We will review the information you have sent us and contact you. If needed, we will follow up with appropriate actions to try and address your concerns or complaints as quickly as possible.
All information will be kept as confidential as possible and will be used only to contact you to follow up on the concern or complaint you are reporting. The medical school provides whistleblowing protection for anyone who reports an activity that violates any regulations and policies on the use of human subjects.
- How to contact the study investigator
Please let us know if you are having difficulties contacting the investigator of a study.
If you are a study participant, most research studies have a consent form or information sheet that is given to you when you are considering whether you wish to participate in the study. The consent form or information sheet will include a “Questions” section that will explain how you can contact the study investigator directly, if you wish to do so.