Abraham Research Participants

Study Participant’s Rights

• To be given the information on:
  • the nature and purpose of the clinical trial
  • the attendant risks, side effects or known discomforts that might be reasonably expected
  • benefits that can be reasonably expected
  • the procedures to be followed in the study, and any drug or device to be used
  • what options or alternative procedures are available and their relative risks and benefits
  • any medical treatments available if complications occur during the trial
• To be allowed to ask questions about the trial before giving consent, and at anytime during the course of the study
• To be allowed ample time, without pressure, fraud, deceit nor any undue influence, to decide whether to consent or not to consent to participate
• To refuse to participate, for any reason, before and after the trial has started
• To receive a signed and dated copy of the informed consent form

 

Study Participant’s Responsibilities and Obligations

By signing the consent form and agreeing to participate, you also assume certain responsibilities. Consent is a covenant of trust between researchers and research subjects. It is your responsibility to tell the truth and to comply with the rules of the clinical trial. If you fail to meet these obligations, the data collected during the clinical trial have no integrity.

 

Always be completely honest when applying to participate in a research study. Some people might neglect to mention things, like a prior medical condition or daily treatment of pain symptoms, which would automatically exclude them from some studies. Others might knowingly participate in two drug studies at the same time – a standard exclusion criterion.

 

Dishonesty invalidates the study results and it is dangerous. Taking two drugs at the same time, for instance, exposes a person to unknown and difficult-to-detect interactions that can cause serious health problems – even death. One drug also may be mistakenly credited for the action of the other, or mask its harmful side effects. Faulty data lead to faulty conclusions about a drug’s safety and, in the end, it may endanger public health.

 

Always follow the study protocol. Protocols are very carefully designed. Failure to comply with the protocol can endanger you and can make the results of the trial inaccurate. Study volunteers who are instructed not to drink any alcoholic beverages but do so anyway may alter important lab results. Volunteers who fail to take the study medication as instructed or ignore their promise to use birth control and become pregnant (not to mention the unknown harm done to the fetus), may invalidate the clinical trial results, not to mention putting themselves at risk. Researchers need to understand how a study medication is working, whether doses need to be adjusted and what side effects the study participants are experiencing.

 

Maintaining a diary is important if it is required in the protocol. Be aware that you must devote time for keeping the diary. Hastily made diary entries will not benefit the research effort.

 

Source: Informed Consent: A guide to the Risks and Benefits of Volunteering for Clinical Trials by Kenneth Getz and Deborah Borfitz.