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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 Â鶹´«Ã½Ó³»­’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 Â鶹´«Ã½Ó³»­'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

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.

Investigators must keep track of which subjects provided broad consent and which subjects refused. Tracking broad consent may require a complex system to tag and track biospecimens and subject consents.

Below is an outline of the broad consent.

Broad Consent

1. Study Title:
2. General description of the types of research that may be conducted using the secondary data:
3. Description of the information or biospecimens that might be used in future research; whether sharing might occur; and the types of institutions or investigators that might conduct research:
4. Description of the length of time that the information or biospecimens may be stored, maintained, and used:
5. A statement about whether subjects will or will not be informed of the details of any subsequent research.
6. A statement that research results either will or will not be disclosed to subjects.
7. Contact information of the investigator
8. Elements from the list below to be included as deemed appropriate
• Risks/Discomfort to human subjects
• Benefits to human subjects
• Confidentiality of the data
• Voluntary participation statement
• Commercial profit (when appropriate)
• Whole genome sequencing (when appropriate)