Appendix ADefinitions (Based on definitions in the Federal Regulations 45 CFR 12/13/01)
Classifications of Research Review
Code of Federal Regulations 45 CFR 12/13/01
Sample Disclosure Form
I am currently conducting a study on____ (purpose of proposed research)______.
I am seeking the assistance of_____ (subjects)______ in completing a questionnaire concerned with______ (focus of questionnaire)_______.
The questionnaire is brief and should take about______ (length of time)_______ of your time to complete. Every effort will be made to keep the information provided confidential. You name does not appear on the questionnaire.
Your cooperation and participation are strictly voluntary and your choice to participate or not to participate will in no way affect your grade. You may leave any particular questions unanswered or may choose not to complete the questionnaire. Your participation is very valuable and will help me ______(contribution of the proposed research)_______.
If you have any questions about this study or would be interested in the results, please contact______(name, title, affiliation)______ ,_____(telephone)_____.
Thank you for your cooperation.
If you have any adverse effects or concerns about the research, please contact the primary investigator or the Office of Graduate Studies and Research at Salisbury University at 410-548-3549 or toll free 1-888-543-0148.
Experimental Subject’s Bill of Rights
To be told what the study is trying to find out
To be told what will happen to you and whether any of the procedures, drugs, or devices is different from what would be used in standard practice
To be told about the frequent and/or important risks, side effects or discomforts of the things that will happen to you for research purposes
To be told if you can expect any benefit from participating and, if so, what the benefit might be
To be told the other choices you have and how they may be better or worse than being in the study
To be allowed to ask questions concerning the study, both before agreeing to be involved and during the course of the study
To be told what sort of medical treatment is available if any complications arise
To refuse to participate at all or to change your mind about participating after the study is started. This decision will not affect your right to receive the care you would receive if you were not in the study
To receive a copy of the consent form
To be free of pressure when considering whether you wish to agree to be in the study.