Information for research participants

Research is an organized way of collecting information to help understand problems and test ideas for the benefit of society. University faculty, students and staff do research in many different areas.

People might participate in research about things like:

• 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

You may have heard the phrase "clinical trial." That is a name for research about health and illness in people, especially when the research compares treatments or uses experimental drugs or devices. You can find more information about "clinical trials" at ClinicalTrials.gov.

A drug or device is called "experimental" when the U.S. Food and Drug Administration (FDA) has not approved it for any use. A drug or device is also "experimental" when the FDA has not approved it to treat the illness that is being studied.

The websites listed in the section below also include general information about research:

• U.S. Office for Human Research Protections
• U.S. Food and Drug Administration
• U.S. Department of Veterans Affairs
• U.S. National Institutes of Health - Clinical Center
• U.S National Institutes of Health - Clinical Trials.gov
• U.S. National Cancer Institute

If you are already participating in research, you are encouraged to communicate with your research team first, especially if you are experiencing medical problems.

You can also contact Research Integrity (see contact information below) for help if:

• you want general information or have general questions about research or your rights
• you wish to discuss problems, suggestions or concerns
• you do not feel comfortable communicating with the study team
• you want advice about how to communicate with the study team
• you have communicated with the study team, but they have not been able to help you

If you contact Research Integrity, every precaution will be taken to maintain your confidentiality. If you report a problem, we might need to reveal your name or other information about you in order to investigate the problem. A representative from Research Integrity will contact you before revealing information about you.

You may contact Research Integrity by phone, mail or e-mail:

Research Integrity
1664 North Virginia Street
217 Ross Hall/Mail Stop 331
Reno, NV 89557
Telephone: 775.327.2368

E-Mail: diaconum@unr.edu

If you do not want to discuss your complaint or concern with the study team, you may contact Research Integrity.

• Advertising appears on television, radio, public transportation and the Internet. Advertising also appears in community newspapers and public areas (bulletin boards, clinic waiting rooms, telephone poles, etc.). Advertising always includes a way to contact the researchers for more information.
• 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.
• University students can ask their professors or department administrators about research participation opportunities. There is also the SONA student pool where students can search studies at the University that offer research experience credit for participation. Students may participate in research in order to satisfy course requirements or to obtain extra credit. However, no student may be required to participate in research without alternatives to satisfy the same course requirement or extra credit. Instructors who require or offer extra credit for research participation will also offer students the choice to substitute comparable non research participation alternative assignments.
• Clinicaltrials.gov (a federal government-run registry that lists many clinical trials conducted in the US and around the world)
• Searchclinicaltrials.org (a website run by a non-profit organization called CISCRP)
• AIDSinfo (a UNAids organization website that lists HIV/AIDS research)
• The clinical trials website of the National Cancer Institute (listings and information)

When you complete everything (or if you leave early), that is usually the end of your participation.

The consent form might describe extra contact with the study team after the study. The researcher might send you information about your participation, including any new information that might 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.

Sometimes the study information from the University will be combined with information from other places doing the same study. If a drug company paid for the research, the company might 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.

You always have the right to leave the research at any time and for any reason, and you do not have to explain your decision to anyone. For example, you might feel less comfortable than you thought you would, or maybe the research takes up too much of your time. Nobody should pressure you into staying in the research if you do not want to.

 You do not have to, but you might want to discuss any problems with the researcher before leaving. They might not be able to do anything if the research plan is not flexible, but it might be helpful for them to know why you cannot continue.

If you leave a medical study, you might be asked to come back once or twice for some extra safety tests. This is to make sure that you are not having any problems related to the study. You do not have to come back, but it is usually important for your safety that you do.

Members of the research team, and when appropriate, others who are involved with your care or who have permission to see your records, will know that you are participating in research. It is a good idea to let your primary healthcare provider know that you are participating in a medical research study because s/he will want to know how this affects your medical care. Otherwise, information about your participation is kept confidential unless you choose to tell someone.

The most important thing to do is take an active role and communicate with the study team before, during and after the research. You should always ask questions if you are not clear about something, if you are curious about something, or if it seems like the research plan is different from what you were told. You have a right to have your questions answered.

Take your time making decisions about whether or not to participate. You should seek the advice of trusted family members, friends or healthcare professionals before and during the research.

If you feel uncomfortable with what you are doing, or if you think you might be experiencing changes in your health (whether good or bad), let the study team know so that they can help you.

Always keep in mind that participation in research is voluntary. If you feel like you are being pressured to join or stay in a study, you can always say no. You can leave the research at any time for any reason, and you do not have to explain your decision. You may, however, be asked to have certain procedures performed for you to safely withdraw from medical studies.

You can also contact Research Integrity with questions about your rights, or any problems or complaints about your experience with research at the University. Click on the link above for contact information.

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 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.

Researchers are searching for new information and new answers to societal or health-related problems. With these answers they hope to design solutions or programs, but these solutions take time. Most research is not intended to provide you with direct benefits. When you participate in research, you are, however, contributing to scientific progress and helping society.

Research is not the same as treatment. In medical research, many of the drugs, devices and procedures being tested are experimental (this means that they have not been proven to work) and there is no guarantee that your condition will get better. There may also be both serious and unknown risks. Some medical research, however, may result in improved health.

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 you questions to make sure that you understand the information.

Once you understand the information and decide 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.

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. 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 fit exactly what they are looking for.

If you do not qualify, it does not mean something is wrong with you. It just means that the study was not for you. There might be other studies that you qualify for.

 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.

Your participation in a research study is voluntary and it is your decision whether or not you want to participate. It is important that you have the information needed to make such a decision. To help you prepare questions you may want to ask the researcher.

Remember: You have the right to get all of your questions answered. If you do not understand the answer, ask the question again.

The researcher will usually give you the information listed below. The information that is followed by an asterisk(*) will be given to you only for medical studies.

• Why the research is being done
• Why you are being asked to participate
• How long your participation will last
• What will happen during the research (what you will do, the drugs you will take, etc.)
• How the research is different from your usual medical care (research is not the same as treatment)*
• Any expected risks or discomforts that you might experience
• How information about you will be protected
• Any expected benefits
• Any expected costs to you or your insurance provider*
• What you can do instead of participating, such as what treatments you can take that might work for you, and how those treatments compare to the research procedures*
• What medical treatment you will get in case of problems*
• Reasons you might be asked to leave the research
• Who can help you with problems or give you more information about the study or your rights

If you are concerned about any issue or you do not feel like you have enough information, ask the researcher your questions at any time before, during or after the research.

While you are participating, you also have the right to be given new information that comes up. This information might include changes to what you will be asked to do, new risks or new treatment options. If you are given new information, you will be asked if you are still willing to participate in the research.

It is a privilege to involve people in research. The University takes this privilege very seriously. Federal regulations, state laws and University of Nevada policies require that the University protect the rights and welfare of research participants. The sections below describe some of these requirements.

Everyone at the University is responsible for following these requirements. Every participant receives the same high level of protection. This is true no matter who pays for the research or where the research actually takes place.

Participants help researchers in many different ways. Depending on the goals of the research, participants might be asked to do things like:

• Take part in interviews (sometimes as part of a group)
• Complete questionnaires, tests or special tasks
• Allow access to private information (such as medical records or school records)
• Let researchers observe behavior
• Complete physical, psychological or other kinds of examinations
• Give samples of blood, saliva, urine or other materials
• Take experimental drugs or use experimental medical devices