1. Social Issues Associated with Occupational Health Studies W. G. Tankersley, D. Cragle Oak Ridge Associated Universities Presented at American Industrial Hygiene Conference and Exposition New Orleans, LA June 5, 2001

2. Acknowledgements ORAU staff –Oak Ridge, Tennessee –Arvada, Colorado DOE overseers DOE contractors staff Participants

3. Contacts Donna Cragle – Oak Ridge, TN – 865/576-2866 Bill Tankersley – Oak Ridge, TN – 865/576-3141 Duane Hilmas – Arvada, CO – 303/423-9585 Bill Stange – Arvada, CO – 303/423/9585 Elizabeth White – Washington, DC – 301/903-7582 Paul Wambach – Washington, DC – 301/903-7373

4. Goals of Medical Research Ideally –No harm to participants –Measurable benefits to participants and/or others –Uncompromised researcher integrity –Results add to scientific knowledge Achievable –Some fraction of ideal

5. History Health studies marked by –Study topics chosen by researchers –Experimental design and protocol determined by researchers –Participation determined by employer management –Little/no input by participants –Results reported in scientific journals –Little direct reporting to participants –Little feedback received by participants

6. Resulting Social Issues/Problems Physical abuse of participants Misuse or abuse of information Negative repercussions from study findings –Employee discrimination –Loss of job –Loss of insurability Lack of communication –Perception of deception by researchers –Guinea pig syndrome

7. Negative Effects on Research Lack of participation Lack of cooperation Data collection handicapped Less than optimal results –Insignificance –Bias –Incompletion of study

8. Perspectives/Goals/Requirements of Researchers versus Participants Researcher –Focus on population –Bound by protocol –Future oriented –Eager to disseminate information –Results = End Participant –Focus on individual –Personal health oriented –Present oriented –Concerned about privacy –Results = Action

9. Addressing of Social Issues Recognition of participants rights –Institutional Review Board approval –Voluntary participation Involvement of participants –Description of methods and goals of study –Solicitation of stake-holders input Communication with all participating members –Reporting of study progress and findings –Acknowledgement/response to participant feedback

10. ORAU-Specific Actions Arrange onsite employee information meetings Participate in support groups Provide participant question/response phone line Assure participants are informed Maintain researcher integrity Involve stakeholders in protocol development for new work

11. Future Issues Reporting of findings to management –Advantages –Disadvantages –Problems Effects of results on employment Genetic screening Insurability Compensation

12. Why be concerned ? Right thing to do Law Scientific benefit Litigation

13. Contacts Donna Cragle – Oak Ridge, TN – 865/576-2866 Bill Tankersley – Oak Ridge, TN – 865/576-3141 Duane Hilmas – Arvada, CO – 303/423-9585 Bill Stange – Arvada, CO – 303/423/9585 Elizabeth White – Washington, DC – 301/903-7582 Paul Wambach – Washington, DC – 301/903-7373