HUMAN SUBJECTS

Human subject review, confidentiality and ethics are huge issues, and every proposal must address these, and be accompanied by appropriate consent forms and questionnaires.  We do not have time in this class to cover this topic in depth, but to help you, here is an example of the Human Subjects section of a recent NIH grant we submitted.

C.                 HUMAN SUBJECTS

E.1.      Proposed Involvement of Human Subjects

This study will rely on material previously collected and now being collected in our ongoing studies of chronic disease among Mexican Americans in Starr County, Texas. To these resources we will add 950 Mexican American individuals from Brownsville. This will include 800 individuals aged 15 to 54 representative of the population and 150 individuals collected in trios consisting of a young onset diabetic and their parents. All individuals will be Mexican American. Children are included in that systematic sampling will go to age 15 and young onset cases will emphasize pediatric cases. The study is designed for equal representation of men and women though in practice our experience shows that differential participation leads to more women than men (estimated to be in the range of 60% women).

E.2.     Sources of Research Material

This study will use the data files from the investigations described above. All previous data have been computerized.  No identifiers are included in the files used for analysis.  DNA has been extracted from buffy coats on all individuals and will be the raw source of genetic material.  These samples are identified by ID number only.  The collection of new data will involve protocols and safeguards similar to that which we have used previously. 

E.3.     Recruitment and Consent

All data collected and protocols (as well as ongoing protocols permitting the use and analysis of the data and samples) have been reviewed and approved by the institutional committee for the protection of human subjects.  Written consent was obtained from all previous participants for the examinations and use of biological materials obtained and will be obtained from all new participants

E.4.     Potential Risks

For existing data resources, there are no substantive risks to participants other than confidentiality. The newly recruited 950 individuals will have minor risks from the phlebotomy involved in blood collecting.