• 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).