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Infor for participants | Medical Research Council of Zimbabwe

Information for Participants

What is an IRB and what does it have to do with research?

Before research studies can start, they must be approved by a committee, usually called an “institutional review board,” or “IRB.” IRBs are made up of scientists, doctors, non-scientists and community members. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the consent form for the research to make sure that it is accurate. If it approves the research, the IRB continues to review the ongoing research after it starts. It is important to understand that IRB approval does not mean that a research project is safe or that it is right for you. When an IRB approves research, it means that the members of the IRB believe that the research is acceptable to present to people like you for your consideration. However, you need to carefully look at the details of the research and decide whether it is right for you.

What is Research?

Research is an organized way to learn more about almost anything. Research is done in many areas, such as engineering, basic science, psychology, and medicine. When research involves people as participants, it is called human participant research.

This website focuses on medical research involving human participants. Medical research is done to learn more about a drug, a medical device, a medical procedure, or a particular condition or behavior. Some of the terms used to describe medical research are: Research Study, Clinical Research, Research Trial, Experimental Study, or Protocol. Whatever it is called, the goal of medical research is to find better ways to treat conditions, improve health or cure diseases for future patients who have a particular health problem.

A research study is done to try and answer a question. The question varies from study to study. The research protocol (study plan) clearly states the question to be asked and discusses all of the tests and procedures that will be done during the research study. If you decide to enter a research study, be sure you know what question the research is trying to answer.

What is a sponsor?

Research is planned and initiated by a sponsor. The sponsor may be a government agency, a pharmaceutical or device company, a public institution like a University or Medical College, or an individual person.

What is a Principal Investigator (PI)?

The principal investigator is the person responsible for conducting a research project at one or more locations. The principal investigator is usually a medical doctor. Your own physician may be the principal investigator for a research study or the principal investigator could be a physician who only conducts research studies.

Principal investigators often have other professionals assisting with the research study. The principal investigator’s research team may include sub-investigators, research coordinators and research nurses. Even if there are other doctors on the research team, the principal investigator is the person ultimately responsible for ensuring that the research is being done according to the protocol (study plan).

What is a protocol?

The protocol is the action plan for how the study will be conducted. All the details of the study are described in the protocol. The principal investigator and other research staff must follow the protocol. If the protocol is not followed, the results of the research study may not be useful enough to answer the questions the research is trying to answer.

What is randomization?

In many research studies, participants are assigned to different groups. The participants in the different groups may receive different doses of drugs, or different drugs, or different devices or other medical procedures. Many times the assignment to a group is made randomly (like drawing a number from a hat). This means that neither the participant nor the investigator chooses which group the participant is placed in. Randomly assigning participants to groups helps ensure that the results from the study are more accurate.

What is blinding?

Research also often uses a technique called “blinding.” Blinding means that the participants and often the investigator do not know what drug or medical procedure they are receiving. There is both single blinding and double blinding. In double blinding, neither the participant nor the investigator knows which drug or procedure the subject will receive. In single blinding, only one person does not know, either the participant or the investigator. Blinding is done to help eliminate the possibility of bias by the investigator and or the participant, and to help the research results be accurate. There are several ways that a study can be blinded. One common way to blind a study is to use a placebo.

What is a placebo?

A placebo looks like a drug but contains no active medicine. In studies that use placebo, all the participants in the research receive drugs that look exactly the same, but do not all have the same ingredients. Researchers compare the information about participants receiving the active drug to the information about participants who receive the placebo. Placebos help ensure that research results are accurate.

Do I have to pay for any of the drugs or procedures in a research study?

You may be expected to pay for some or all of the tests and procedures that will be done during the study. It is different in each study. Sometimes everything is paid for in a research study, and sometimes you or your insurance will be responsible for all of the costs. Also, be aware that sometimes insurance companies will not pay for medical care that is given as part of a research study, so you may be responsible for those costs.

Will I be paid to participate in a research study?

Sometimes participants are paid to participate in a research study. For studies involving individuals with medical problems, the amount of payment is usually based on how inconvenient it is for participants to come in for the extra visits and to have additional procedures performed. Therefore, the payment will often cover costs like transport.

Research studies for healthy people generally pay more, as these participants have no medical problem and may have little other reason to join the study.

What is the consent form?

Before you enter a research study, you will be given a document called a consent form. Read the form carefully. It should tell you what you need to know in order to decide whether or not to enter the study. For example the consent form should tell you:

  • why the study is being done,
  • how long your participation will last
  • the potential benefits to you,
  • the potential risks to you,
  • the standard medical options for your condition
  • if there is payment for participation
  • the plans to deal with a research related injuries
  • who will receive information about you from study

 

Risks and benefits of research

 

Are there risks in research?

Joining a research study will usually involve risks. Those risks vary from study to study. You should understand what risks are anticipated in the particular study you are considering and remember that there can always be unanticipated risks for research participants. The risks should be clearly explained in the consent form.

Will I benefit if I participate in research?

Sometimes the person (participant) who joins a research study will benefit directly, and their disease or problem will be helped. However, the possibility of receiving benefit varies from study to study, just like the risks. It is important to remember that the main goal of research is to collect information that may help future patients, not the participants participating in the research study. You should always ask questions and keep asking until you understand how the research study is different from the treatment you would get outside of the research study.

What are my rights as a research participant?

You have several rights as a research participant:

  • You have the right to decide not to participate in the research, and there will be no penalty or loss of benefits.
  • If you decide to participate, you have the right to quit at any time. Again, there will be no penalty or loss of benefits.
  • You have the right to be informed about the research study, without any coercion, undue influence, or pressure. Your main source of information about the research study is usually the consent form.
  • You have the right to ask questions about the research study.
  • You have the right to get a copy of the consent form.
  • You do not waive any of your legal rights by joining a research study or signing a consent form.

Deciding to be in a research study is an important decision and requires that you understand what your expectations are. You should talk about your expectations with the study staff before you agree to be in a research study.

Who can I contact when I have questions or concerns?
  • If you are in a research study reviewed by the IRB (MRCZ), the consent form includes information about who you can contact.
  • For specific questions about the study or to make appointments, please call the study staff listed in the consent form.
  • You can call the MRCZ if you have concerns or complaints you would like to talk about with someone who is not working on the study. If you have a study consent form, please have it available during the time you are calling.