APPENDIX A FORM A PROTOCOL FOR RESEARCH INVOLVING HUMAN SUBJECTS. Department/College:

Transcription

1 APPENDIX A FORM A PROTOCOL FOR RESEARCH INVOLVING HUMAN SUBJECTS Project Title: Department/College: By signing below, I acknowledge that I have read the attached research protocol and that it meets the current IRB requirements listed in both Appendix B and C of the Guidelines for Investigators. Principal Investigator (Printed): Principal Investigator (Signature): Faculty Advisor (Printed): Faculty Advisor (Signature): Researchers Department Head (Printed): Department Head Signature: IRB USE ONLY IRB FILE NUMBER: ALABAMA STATE UNIVERSITY S INSTITUTIONAL REVIEW BOARD FOR THE USE OF HUMAN SUBJECTS IN RESEARCH PROTOCOL APPROVED w/modifications OR REVISIONS PROTOCOL DISAPPROVED EXEMPT FROM REVIEW EXPEDITED REVIEW FULL BOARD REVIEW Revised Reviewed by: 1

2 APPENDIX B INSTRUCTIONS FOR HUMAN SUBJECTS PROTOCOL 1. Purpose of the Study: Provide a brief statement of what you expect to learn from this experiment. 2. Subject Population: Estimate the number of human subjects to be involved in each phase of the study. State the ages of proposed subjects, your reasons for their selection, and identify the locations from which they will be drawn. 3. Experimental Methods and Design: Provide a brief summary of your research project. Explain, in lay language, what you are proposing to do and how you will conduct each phase of the project. Do not assume certain procedures will be understood. Explain them. Avoid general terms such as tests or groups, unless you have clearly identified them and explained how they will be used or classified. Use examples if it will clarify your intent. Attach extra sheets if necessary. Identify test instruments (surveys, questionnaires, etc.) you plan to use in this experiment. If you are using a specially constructed format, please provide copies of each document for distribution to Board members. If deception is to be involved in this study, provide adequate rationale for its use. Describe provisions for debriefing or follow-up contact with your subjects. 4. Risks: Describe all potential risk (physical, psychological, social, and confidentiality). Estimate frequency, severity, and reversibility of risks. Be sure to identify risks in consent form. 5. Precautions: Describe steps you have taken to minimize or eliminate risks. Explain the means for monitoring to detect hazards. State the point at which a subject s participation (or research project) would be terminated. Clearly define circumstances under which a subject would be referred to an appropriate agency for counseling or treatment to an appropriate agency for counseling or treatment of preexisting or acquired conditions. 6. Benefits: Describe perceived benefits to subjects of this research. Include any form of compensation offered participants, explain proposed reimbursements, and identify services which would be provided at reduced or no cost to subjects. Explain provisions for withdrawal of subjects from experiment and how this would affect benefits. Describe possible benefits to persons other than subjects. 7. Confidentiality: Describe procedures you will use to maintain confidentiality of data and identity of subjects. Tell who, besides yourself, will have access to the data and what safeguards have been taken to assure complete confidentiality. If data will be coded, explain methods to be used. 2

3 8. Location of Experiment: Specify the location(s) where contact with subjects will occur. You should be sure to obtain permission for use of facilities from proper authorities. 9. Duration: Estimate the duration of the entire study. IRB approval is given for one year; studies which exceed one year must be returned to the IRB for renewal of approval. This does not mean that once contact with subjects is complete your need not request renewal. IRB overview is required as long as you are in possession of data in which subjects can be identified. A final report will be required to close IRB files. These forms can be found in the appendices of this document. 10. Source of funds: State source of funds for this research. 11. Informed consent: Alabama State University s IRB will work with a format which contains the basic elements of informed consent as required by the Department of Health and Human Services. Consent forms submitted to the Board must conform to the approved format. Be sure that the language and terminology used in your consent form is appropriate and understandable to your subject population. Special circumstances may require more than one consent form. You should check with the Chairperson of the IRB if you feel this may be the case with your study. 3

4 APPENDIX C CHECK LIST FOR A WRITTEN CONSENT FORM The form should cover the following points: 1. A statement of the general purpose of the study should be given. 2. An invitation to participate should be offered. Points 1 and 2 can be combined in language such and You are invited to participate in the study of We hope this study will help us to 3. The reason this subject was selected (e.g. because he is a normal adult male, has asthma, or has relatives with a specific disease) should be stated. If the statement of purpose of the study identifies subject population, it need not be repeated here. 4. A description of the procedures to be followed should be given, including their purposes, how long they will take, and their frequency. Use of randomization or placebos should be disclosed. If any of the procedures are experimental, they must be identified as such. For purposes of this special identification, a procedure is experimental if there has not been sufficient experience with it to establish a general professional consensus concerning the risks of its use in circumstances similar to those of the study. This section should begin with If you decide to participate, we will 5. The discomforts and inconveniences that might be reasonable expected should be described. An estimate of the total amount of the subject s time must be included if it is not clear from the procedure description. For example: This study will take seven periods of approximately two hours each. The periods will be in seven consecutive weeks. 6. A description of any risks of involvement, if any, should be presented. Merely writing Minimal risks is not enough. If risks included possible physical injury, state if compensation and medical treatment are available and, if so, what it consists of any where further information may be obtained. 7. If any benefits to the subject can reasonably be expected, they should be described. The suggestion of a benefit can be a strong inducement to participate, so it should be limited to substantial and likely benefits. If benefits to controls are different from the benefits to other subjects, this should be made clear. If benefits are mentioned, it should be made clear that the research cannot and does not make any guarantee that the benefits will necessarily occur. 8. If any standard treatment is being withheld, this should be disclosed. If there are any other appropriate alternative procedures that might be advantageous to the subject, describe them. Appropriate and advantageous should be interpreted in terms of the spectrum of responsible professional judgment alone. If other members of the investigator s professional would consider 4

5 an alternative appropriate and advantageous, the investigator should mention it, notwithstanding his personal opinion to the contrary. He may, of course, mention the reasons for his opinion. 9. Confidentiality must be maintained. If data obtained will be made available to any person or organization other than the subject, the investigator, and the investigator s staff, the person or agencies to which information will be furnished, the purpose of the disclosure, and the nature of the information to be furnished must be described. This section should begin: Any information that is obtained in connection with this study and that could identify you will remain confidential and will be disclosed only with your permission. If you give your permission by signing this document, we plan to disclose.. Data in the form of recordings, photographs, movies, or videotapes will require special attention. If such records will be made, they should be described, regardless of whether they will be shown to others. The maximum period of time they will be retained before destruction should be disclosed. Showing or playing such data for any purpose must be disclosed. They can be shown or played only in the situations to which the subject consented. Special attention should be paid to disclosing all showing or playing for instructional purposes. There is always the possibility that someone in the audience will recognize the subject in a visual recording. Because of the significant risks to the subject, the investigator should exercise considerable discretion, even when consent to the showing has been obtained. If a subject can participate in the study without having information on audio or visual recordings shown to others, that fact should be disclosed. This can be accomplished either by indicating that the subject may cross out the portion of the consent form dealing with disclosure or by preparing a separate document. 10. A statement of the amount of payment to be received by the subject, if any, should be described or stated. If subjects receive services or treatment at a lower cost than would be charged non subjects, the reduction in cost is a form of compensation for participation in the study. If the subject receives extra credit for participation in the study, the amount of credit should be stated. If there is a potential of additional cost to the subject because of participation in the study, it must be disclosed. 11. An indication that the subject is free to decide not to participate, or later to withdraw his consent and discontinue participation in the study without penalty must be given. This can take the form of: Your decision whether or not to participate will not prejudice your future relations with Alabama State University. If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time without penalty. 5

6 12. An offer should be made to answer any inquiries concerning the procedures or the study. Include the name and telephone number or address of an investigator that the subject can contact if they have further questions. 13. Conclude with (in all CAPS): YOU ARE MAKING A DECISION WHETHER OR NOT TO PARTICIPATE. YOUR SIGNATURE INDICATED THAT YOU HAVE DECIDED TO PARTICIPATE HAVING READ THE INFORMATION PROVIDED ABOVE. 14. Provide space for signatures and the date of signature. If the subject is legally competent, the subject must sign the form. If the subject is not legally competent (e.g. minor, an mentally disabled person), the guardian or parent of the subject must sign the form after receiving the explanation of the study. There should be space for the signer to indicate the relationship of the signer to the subject. 15. The person who actually explained the study and interacted with the subject in the consent process should sign the form. This person need not always be the investigator. The investigator can delegate the function of soliciting consent to anyone who is capable of answering the questions from the subjects; however, this delegation does not reduce the investigator s responsibility to obtain effective informed consent. Participant s Signature Witness 6

7 APPENDIX D RENEWAL OF APPROVAL FOR RESEARCH INVOLVING HUMAN SUBJECTS Project Title: Department/College: Department Head: Signature Faculty Advisor: If Appropriate Principal Investigator (Printed): Principal Investigator (Signature) 1) Review the activities of the proceeding year, in lay language. 2) Have there been any adverse effects to subjects or unexpected difficulties with procedures or techniques? 3) How many subjects were actually involved in the research? 4) If any of your subjects have withdrawn from participation, state how many and why. 5) Do you anticipate any changes from the original protocol? If yes, explain. 6) Have there been any unanticipated benefits resulting from your study? If yes, explain. 7

8 APPENDIX E FINAL REPORT FOR RESEARCH INVOLVING HUMAN SUBJECTS Project Title: Department/College: Department Head: Signature Faculty Advisor: If Appropriate Principal Investigator (Printed): Principal Investigator (Signature) 1) Please summarize and evaluate your research project. 2) Were there any unanticipated difficulties or adverse effects to subjects? 3) Were there any unanticipated benefits to subjects or others resulting from the study? 4) How many subjects were involved with the study? How many subjects completed the entire study? If there were any subjects who withdrew from this study, do you know why? (If yes, please explain) 5) If informed consent forms were required, where will they be maintained? 8

9 APPENDIX F DEFINITIONS 1) Human Subjects: An individual about whom an investigator obtains (1) data through intervention or interaction with the person, or (2) identifiable information. 2) Minimal Risk: The probability and magnitude of harm that is normally encountered in the daily lives of healthy individuals, or in the routine medical, dental or psychological examination of healthy individuals. 3) Research: A formal investigation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research whether or not they are supported or conducted under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 4) Subject At Risk: Any individual who may be exposed to the possibility of injury, including physical, psychological, confidentiality, or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet the individual s needs, or which increase the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service. 5) Confidentiality: The protection of data collected during the course of a research project in order to safeguard the identify and responses of participants. 6) Informed Consent: The disclosure and understanding of information which enables an Individual to make a decision whether or not to participate in a research activity. 9

10 APPENDIX G REQUEST FOR REVISION OF APPROVED IRB PROTOCOL Project Title: Approved Protocol ID: Department/College: Department Head: Signature Faculty Advisor: If Appropriate Principal Investigator (Printed): Principal Investigator (Signature) Changes to any section of Appendix B (Instructions for Human Subjects Protocol) must be approved by ASU s IRB PRIOR TO IMPLEMENTATION OF THOSE CHANGES. Please indicate the nature of the changes by checking the appropriate boxes below AND provide descriptions of the changes as notes below the appropriate items in your currently approved Appendix B. Changes to Appendix B are likely to result in changes to your Informed Consent. If changes to the Informed Consent are required, please include your revised Informed consent with Appendices B and G. Failure to include an appropriately revised Informed Consent will result in a delay in your request for revision. 10

11 Type of change requested (check all that apply) Change in Subject Population Increase in number of subjects Inclusion of vulnerable population Minors (under age of 19) Pregnant women Prisoners Cognitively-impaired persons Terminally ill persons Change in Design & Methods Change in Risks Physical risks Psychological risks Confidentiality Change in Precautions Change in Benefits to Subjects Change in Procedures for Maintaining Confidentiality Change in Location of Research Change in Duration of Research Change in Source of Funding Change in Informed Consent (may be required as function of other changes) 11