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Scientific research involves gathering data, information or facts in order to advance knowledge. At the Schroeder Institute, our research studies focus on tobacco use. All the studies listed on this site are clinical studies, meaning they involve human volunteers.  

There are strict rules for research studies, which are monitored by federal agencies such as the National Institutes of Health and the U.S. Food and Drug Administration. Some research studies involve promising treatments that may directly benefit you or others.

(Adapted from the NIH Clinical Center: http://clinicalcenter.nih.gov/participate/faqaboutcs.shtml)

IRB stands for Institutional Review Board, which is an independent committee outside of the Schroeder Institute that reviews, approves, and monitors research studies prior to the start of the study. The IRB monitors the conduct of the research study throughout the entire study to ensure that the research is conducted according to the protocol and that the appropriate steps are taken to protect human subjects.

Tags benefits, IRB, risks

Your participation in any research study is voluntary. For every study in which you intend to participate, you will receive a document called "Informed Consent" that explains the study in straightforward language. It will state who is conducting the study, the purpose of the study, and what your involvement in the study will be. It will clearly state if there are any risks to participating and what is being done to minimize those risks. It will also describe the benefits that you may receive from participating. The informed consent document will contain the contact information for the investigators as well as the IRB. This is an important document that you should save.

A member of the research team may discuss the research study with you, explain its details, and answer your questions. You will always be able to ask a member of the research team questions.

Reading and understanding the informed consent document is your responsibility. You may discuss it with family and friends. You will not be hurried into making a decision, and you will be asked to sign or accept the document only after you understand the nature of the study and agree to the commitment.

At any time after signing the informed consent document, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely, or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you just need to inform the research team of your decision and you will be free to leave the study.

(Adapted from the NIH Clinical Center: http://clinicalcenter.nih.gov/participate/faqaboutcs.shtml)

The involvement of participants as partners in scientific research is crucial to its success.  Breakthroughs in medical treatments have benefited millions of people, and this could not have happened without the involvement of people willing to participate in research. Your involvement in a research study will be short term, but can help to improve the health of future generations.

You may also directly benefit from participating in a research study. These potential direct benefits are described in the informed consent document of each individual study.

(Adapted from the NIH Clinical Center: http://clinicalcenter.nih.gov/participate/faqaboutcs.shtml)

Some of our research studies involve non-smokers while others involve current smokers. Each study provides detailed information about eligibility criteria and the nature of the research.

Each research study has a different time commitment. Some studies require a high degree of commitment (such as coming into the office in person, or taking many surveys over a long period of time), while others involve a much lower level of commitment (such as completing just one survey over the Internet). Each of the Active Studies listed here provide details about the commitment required. 

Many of our research studies do compensate participants for their time. Each of the Active Studies listed here provide details about available compensation.

Randomization is a process used in scientific experiments to assign study participants to a treatment condition randomly. It may involve a simple method, like a coin toss or drawing numbers blindly from a basket, or it may involve more elaborate methods that involve a computer program.

Participants that have been randomized to the intervention condition receive the treatment that is being evaluated.  Participants that have been randomized to the control condition receive a different intervention.

Because the assignment to the two different treatment conditions is done randomly, the two groups are expected to be statistically equivalent at the start of the study. Any differences at the end of the study can be said to be due to the intervention itself.

Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring.

The specific risks associated with any research protocol are described in detail in the informed consent document, which you are asked to sign before taking part in research.

Any major risks of participating in a study will be explained to you before you decide to participate. You may always ask questions to the research team about participating, either before, during, or after your participation in the research study.

Participating in a research study may have benefits to you as a participant. Well-designed and well-executed clinical trials provide the best approach for participants to:

  • Play an active role in their health care.
  • Gain access to new research treatments before they are widely available.
  • Receive regular and careful medical attention from a research team that includes doctors and other health professionals.
  • Help others by contributing to medical research.

(Adapted from the NIH Clinical Center: http://clinicalcenter.nih.gov/participate/faqaboutcs.shtml and http://www.nih.gov/health/clinicaltrials/basics.htm)

After a research study is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further research.

Results from research studies are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a research study, it may become the standard of medical practice.

Ask the research team members if the study results have been or will be published. Published study results are also available by searching for the study's official name or Protocol ID number in the National Library of Medicine's PubMed® database. You can also find links to published study results on this website, on each individual study page.

(Adapted from the NIH Clinical Center: http://www.nih.gov/health/clinicaltrials/basics.htm)