Important Information For Developing Informed Consent Forms

Research Involving Human Participants Informed Consent

Informed consent is one of the primary ethical requirements underlying human subjects research, reflecting the principle of respect for potential subjects. Informed consent assures that prospective human subjects understand the nature of the research and can decide knowledgeably and voluntarily whether or not to participate.

Informed consent refers to the voluntary choice of an individual to participate in research based on an accurate and complete understanding of, among other things, its purposes, procedures, risks, benefits, alternatives, and any other factors that may affect a person's decision to participate.

The basic concepts of the consent process include full disclosure of the nature of the research and the subject's participation, adequate comprehension on the part of the potential subject and voluntary choice to participate.

Informed consent must be documented by use of a written consent form approved by the IRB and signed by the participant or the participant's legally authorized representative. A copy should be given to the person signing the form. Even though the IRB has approved a consent procedure, it is the investigator's responsibility to ensure that each potential subject understands the information and to take the appropriate steps necessary to gain that comprehension.

Individuals may not be involved as research participants unless a) they understand the information that has been provided and informed consent has been obtained, or b) the IRB has approved a waiver for informed consent.

REMEMBER: if the participant is under the age of 18, parental consent is required. This includes college students under the age of 18. If the research involves the participation of minors (under 18 years of age), read the description of requirements for research involving children. Additional requirements concerning parental consent forms and child assent are discussed.

Please follow the instructions for documentation carefully.

1. The consent form should be written in language that the participants can understand. Whenever possible, simple declarative sentences should be used. Ordinary language should explain technical terms.
2. Avoid the use of exculpatory language through which the subject or the representative is made to waive or appear to waive any of his/her legal rights or release the investigator, sponsor or institution or its agents from liability for negligence.
3. Important information that must be included on the Consent Form:
   1. Purpose of the research
   2. Procedures to be followed (what will the participants be asked to do? Include physical requirements or experimental procedures if applicable.
   3. Foreseeable risks or discomforts to the subjects. What are the risks associated with participating and what safeguards are in place? Include the following statement, where appropriate:
      “In the event of physical injury resulting from the research procedures, no form of compensation is available. Medical treatment may be provided at your expense or at the expense of your health care insurer (i.e., Medicare, Medicaid private payor) which may or may not provide coverage. If you have questions it is your responsibility to contact your insurer.”
   4. Benefits to the subject or others which may reasonably be expected to result
   5. Alternative procedures or alternatives to participation, if any
   6. Level of confidentiality of participant records. Is data anonymous? How will data be stored? If audio or visual records are obtained how will they be maintained? Who will have access to the data?
   7. Primary investigator’s contact information. Point of contact for questions or problems related to this study.
   8. IRB contact. Also note the study was approved by Florida Institute of Technology’s IRB and list the current IRB Chair and his/her contact information for questions about the rights of people who take part in research. "For information about the rights of people who take part in research, please contact Florida Tech's Institutional Review Board at [phone number]."
   9. Voluntary participation, refusal, and withdrawal. Include the following statement:
      “Participation is voluntary. Refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. You may discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled.”
   10. Signatures, if appropriate. Provide a place for:
       1. Signature of the participant (or his/her legally authorized representative)
       2. Date of signature

Waiver of Informed Consent

The IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent outlined above, or waive the requirements to obtain informed consent provided the IRB finds and documents that the following four conditions have been met:

• The research involves no more than minimal risk to the subjects;
• The waiver or alteration will not adversely affect the rights and welfare of subjects;
• The research could not practicably be carried out without the waiver or alteration; and
• Whenever appropriate, the subjects will be debriefed — provided with additional pertinent information — after they have participated in the study.