A major component of any proposal is the method by which the researchers will obtain voluntary and informed consent from subjects. Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand.
Copies of signed consent forms must be retained for three years after completion of the research and must be available for IRB review if necessary.
It is your job as a researcher to make sure that each person thinking about being in your study has the information necessary to make an appropriate decision about participation. You may have struggled with a number of ways to speak to each participant in a language that they can understand. The consent process becomes informed when risks and benefits are known and when purposes are clear prior to making a decision about participation.
Consent must be documented in some way. Written consent forms are most frequently used with adult participants. Written forms are signed by the participant and dated. A copy of the consent form should be given to the participant. If your study includes persons under the age of 18 you must receive documented approval from the parent or guardian of the child. The document you write is called a "Parental Permission Form". The form includes all the elements of an adult's consent form. Additionally, you must tell the children about the study and their rights. If this is done in writing, the form should be labeled "Assent Form." Keep the language simple and the idea paramount.
Make a clear statement that you plan to do research. List the objectives of your study and a short description of your methods. Remember to keep the statements free of words that are long and complex.
Make a clear statement that people have the right not to participate in the study. Continue by telling them that they have the right to withdraw at any time for any reason. Let the participants know that withdrawal from the study will not effect any benefits that would normally come to expect from you or the University.
t is important to tell the participant about the estimated time involved to participate, the number of participants in the study, and the procedures to be done. This information will help participants understand what to expect.
In simple non-technical language, tell which parts of the study are experimental, and if there are alternatives to these procedures.
Every study has some form of risk to it even though the risks may be unforeseen and remote. List the risks that come with participation in your study. Risks may be discomfort or in some cases physical or psychological pain. Help define the cost of participation in a realistic manner. List how you intend to provide for, or minimize the potential risks. Share who is responsible for paying for treatment should adverse effects occur.
List any of the benefits or compensation that can reasonably be expected by volunteers. If none can be foreseen, include a statement that no immediate or direct benefits may be expected. You may wish also to include benefits to society. Tell who will receive benefits from the study.
All participants need to know that they can leave the study at any time, for any reason. This right should be prominent. Additionally, you should state conditions that would lead you to terminate the participation of a subject. Tell the participant that there are no negative consequences for leaving the study.
You may not be able to answer all the questions about your study when you first meet with a participant. To help with questions that may occur later, list your name and how to contact you. For questions about subjects rights list Dr. Louis De Maio, IRB administrator, as the appropriate person (218-477-4643).
Research involving minors may require their assent, i.e., the minor's agreement or willingness to participate in the study. This is in addition to parental or guardian permission. Assent may only come from children capable of making this decision. Parental permission may suffice when a child is not capable of making this decision. Regardless of the situation, investigators are required to provide a method of assent with their IRB proposals involving minors. This may include, but not limited to the following: 1) letter of assent signed by the minor; 2) statement of assent read or communicated to the minor; 3) a procedure whereby assent is implied by the child's active participation; and 4) a statement explaining why assent is not necessary. In the latter case, a minor's assent may not be required, e.g., minors involved in classroom activities that are part of their required curriculum and instruction.
Regardless of the method of assent used by the investigator, minors may not be coerced, actively or passively, into participating in a study. Furthermore, any statement, written or expressed verbally, must be communicated in ways that the minor will understand.
Investigators may request exception to or waiver of assent procedures in their particular study. However, their request must come before the entire IRB for approval, and may not be handled through exempt status or expedited review proposals. In order to do this, investigators must submit to the IRB 10 copies of a written proposal along with any supporting documentation explaining their reasons for exception or waiver. Federal regulations provides for exceptions and waivers.
Answers to Frequently Asked Questions (FAQ) regarding the treatment of minors by the U.S. Department of Health and Human Services, Office of Human Research Projections may be found at the following link: http://www.hhs.gov/ohrp/researchfaq.html.