The greatest risk to your subjects when participating in genetic research is the inappropriate release of personal and private information. Therefore, concerns for how the investigator and study team will maintain the confidentiality of the data and specimens collected during the conduct of research studies are primary concerns of the CPHS. The protocol and informed consent form should be certain to address the following points:

• Addition of a statement indicating that all study information is coded and personal identifiers maintained securely.
  
• Addition of information regarding how confidentiality will be maintained throughout the life of the study. This description should include information regarding who will be responsible for care and release of samples from the human derived biological samples (HDBS) bank.
  
• Clarification regarding the investigator’s plan to maintain the HDBS specimens, the time frame for storage (for a limited time or indefinitely), and timeline for discarding the collected samples.
• Clarification whether clinically relevant information may be uncovered during the course of the study; and providing the participants the opportunity to decline receiving this information.
• Addition of specific information when children will be the research participants, including how consent will be obtained and how collected data will be handled.
• Addition of a statement indicating that participants may derive no benefit from participation.
  
• Addition of a statement indicating that study data will not be recorded in the patient's medical record. CPHS stipulates that research records are kept separate with controlled access.
  
• Addition of information regarding any special risks associated with their participation (e.g. changes in family relationships, risks to privacy, confidentiality, insurability, employability, immigration status, paternity suits).
• Clarification regarding the release of study results to participating subjects.
  
• Clarification regarding the development of clinically relevant information from the genetic sample, and a query to participants if they wish to be re-contacted with this information.
• Addition of a statement regarding if there is a potential for commercial value that could be derived from the research, and a statement regarding whether subjects will be asked to waive any rights or control over the genetic sample collected.
  
• Addition of the following statement (if applicable): Human derived biological samples (HDBS) bank administered by the University of Texas Health Science Center Houston (UTHSC-H) will remain with UTHSC-H unless the UTHSC-H agrees to release and/or transfer the samples. Please be aware that if the PI leaves the University, the samples within the HDBS bank will remain the property of UTHSC. The University’s ownership includes the right to transfer ownership to other parties, including commercial sponsors.
  
• Addition of the following statement: The (PI) or the subject does not have any ownership or proprietary interest in the human derived biological samples (HDBS).
  
• Addition of a precise description of the purpose for which human derived biological samples (HDBS) will be used. Research subjects should be offered the options of allowing the use of their samples for any research purpose (including purposes beyond those contemplated at the time of the initial study), of restricting the use of their samples for specific enumerated purposes (for example excluding research involving abortion or reproduction), or of restricting the use of their samples only to the specific research outlined in the initial proposal.
  
• Addition of information regarding the participant’s rights and explanation of the procedures that will be implemented if the participant decides to withdraw from the study. The research subject must be advised of the options available to them following a decision to withdraw from the study involving the human derived biological samples (HDBS) bank. For example, the right to discontinue participation in the research project may be restricted to the right to withdraw from further donations of HDBS; existing samples would remain within the HDBS bank and used in any manner initially described. Alternatively, the research subject may be offered designated options which transpire on study withdrawal. For example, the research subject may be offered the right to have any samples destroyed, stored indefinitely, or request that the samples become anonymous.

For HDBS research that includes genetic analysis, the following additional items must be addressed:

• Clarification regarding who will receive derived genetic information (e.g. the patient, family members, non-participating family members, family physician, other physicians, other investigators).
  
• Clarification regarding whether a family pedigree will be published or presented; and clarification regarding if there is a possibility of individuals being identified as a result of their participation.
  
• Clarification regarding if genetic counseling will be made available to participating subjects; and clarification of who will cover the costs of the offered genetic counseling (if applicable).
  

Additional Consent Language for Genome Wide Association Studies

Purpose: The purpose of Genome Wide Association Studies (GWAS) is to compare your genetic information (information passed down to you from your parents that determines all of your traits such as your eye color and body size) with genetic information from other individuals to look for similarities and differences that may help doctors find new or better treatments for many diseases (such as asthma, cancer, diabetes, heart disease, mental illnesses, etc).

If you agree to take part in this study your DNA (genetic information) will undergo genome-wide analysis (all of the instructions that make up your body) and your genotypic (the genetic code) and phenotypic (the expression of the genetic code) data will be shared for research purposes through the NIH GWAS data repository.

Risks of GWAS – The greatest risk of sharing your genetic information is the possible loss of your privacy. Although no identifiable information (name, address, etc.) will be given to the National Institutes of Health (NIH) (the federal government agency that will store your genetic information), the possibility exists that your genetic information may be taken, used for reasons outside of this project and linked back to you. If your genetic information is linked back to you in the future, it may be used by employers and insurance agencies to discriminate you, or by law enforcement to link you (or your family member) to a crime.

If you are part of a small community or a special group of people, your genetic information may be used to draw conclusions about your community or group. Your information may also be used to increase the information available about genetic differences between groups or communities. Genetic differences that cause health problems can lead people to have negative ideas about certain groups or communities.

You should also be aware that the NIH GWAS database is the property of the U.S. government and that these records are subject to the Federal Freedom of Information Act. If people request information under this act, NIH may be required to release records, including your genetic data, but will not release identifying information about you.

Study Withdrawal – You can withdraw your consent to take part in this GWAS study at anytime. If you withdraw your consent, the study doctor will request that your information be removed from the governmental data bank for future sharing. However, if your genetic information has already been given to other researchers, it can not be taken back.

Return of GWAS Results - there is no plan to return to you or your doctor the results from this GWAS study.