Clinical study guidelines
Taking part in a clinical study is entirely voluntary.
Personal benefit may not result from taking part in the study, but knowledge will be gained that may benefit others.
Any significant new findings that result from the study will be discussed with the research subject.
Participants may withdraw from this study at any time without penalty or loss of any benefits to which they are otherwise entitled.
If health conditions arise that would make the subject's participation possibly dangerous or if other conditions occur that would make participation harmful to the subject's health, his physician may discontinue the subject's participation.
All precautions are taken to maintain confidentiality of the participant's medical record. The image database established through this study will contain only the participant's information in the forms of an ID number, age, gender and race so as to identify attributes relevant to the study. However, medical records are available to physicians and researchers involved in the study for the purpose of evaluation of results. If the record is used or disseminated for government purposes, it will be done under conditions that will protect the subject's privacy to the fullest extent possible consistent with laws relating to public disclosure of information and law-enforcement responsibilities of the agency.
The participant or his insurance carrier is responsible for the costs of clinic visits, any hospital admissions, laboratory tests and any other tests. Insurance coverage cannot be guaranteed for all tests and treatments related to this study. Since all of the clinical visits are standard and approved, it is not expected participants will have many increased costs because of enrollment in the study.
Research subjects are provided no compensation for participating in the study. The policy of East Carolina University and/or Pitt County Memorial Hospital does not provide for compensation or medical treatment for subjects because of physical or other injury resulting from the research activity. However, every effort will be made to make the facilities of the School of Medicine and Pitt County Memorial Hospital available for the treatment in the event of such physical injury.