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HOW TO COMPLETE THE EHS RESEARCH ETHICS APPLICATION FORM September 2010 TABLE OF CONTENTS EHS REC Cover sheet Questionnaire 2 Chair s Decision Form. 3 Guidelines on Completing EHS REC Application
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14 Sample Questionnaires. 15 Appendix A—Questions 1, 3, and 5 of the Clinical Global Impressions — Impact of Healthcare Providers' Treatment, Attitude, and Engagement with Patients with Disabilities questionnaire. 16 Appendix B—Questions 1, 3, and 5 of the Patient-Centered Outcomes Research Institute questionnaire. 17 Appendix C—Results from a survey of patients with disabilities. 18 Appendix D—Questions 1, 3, and 5 of the Healthcare-Evaluating Survey. 19 Adverse Events. 20 Appendix E—A sample of patient survey questions. 21 Appendix F—Examining the results from studies of physical and mental health outcomes in persons with disabilities. 22 Appendix G—Sample of questionnaire results. 23 Appendix H—Survey Data on Disability Attitudes: A Comparative Survey (MADE). 24 EHS Risks of Reexamination in the Presence of Other Complications and Disability. 25 Appendix I—Questions 1, 3, and 5 of the Healthcare and Social Services Survey Questionnaire 23. All figures include patient enrollment and are subject to revision. Percentages and percentages in this table and in the Appendix A and B, Questionnaires, shall be interpreted as a range. The first digit represents a 1 to 8-point range. 1The purpose of EHS research is to develop and maintain a national database of knowledge related to EHS. Accordingly, this research is organized, managed, and evaluated under the policies and procedures of the National Institute of Mental Health, Division of Applied Research and Education (ARE). 2The EHS questionnaire is not a substitute for physical examination, especially in the preclinical environment. Physical examination of the patient may be helpful in gathering EHS-related information not covered in the questionnaire. The questionnaire is provided in addition to other evidence-based care. 3To be accurate, answers to the EHS questionnaire should be in accordance with the regulations of the U.S. Department of Health and Human Services, Office of the Secretary, Office of Human Research Protections. An error in or omission from this document, in whole or in part, is not grounds for refusal of participation in EHS research. This online EHS Research Ethics Application (Application), designed to help clinicians and patients decide how to comply, will serve as the basis for research data collection, data analysis, and publication. EHS Research Design The EHS research design is designed to be consistent with the principles of the U.S.

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