Research Question
Among older adults, 65 years or older (P), are the new fall prevention protocols (I), compared to the existing fall routine care (C), effective in the reduction of falls by twenty percent (O), within three months (T)?
Procedure section is clear, described in detail, specific, and all inclusive. Written in lay language (as documented by reading level score). Includes risks and benefits relevant to study. Address assent (if applicable).
IRB Application
1) Provide background information for the study including the objective of the proposed research, purpose, research question, hypothesis and other information deemed relevant.
2) Describe the research design of the study (i.e., state whether the study is correlational, experimental, etc. and define the variables).
3) Describe the tasks that participants will be asked to perform including a step by step description of the procedures you plan to use with your subjects. Provide the approximate duration of subject participation for each procedure/ instrument and the frequency and setting of each administration. Identify any personnel who will assist with data collection.
4) Describe the recruitment procedures. Explain who will approach potential participants and take part in the research study and what will be done to protect the individual’s privacy in this process.
5) Describe how participants will be debriefed.
1) Will data be recorded by audiotape? No 0 Yes 0
Will data be recorded by videotape? No 0 Yes 0
Will photographs be taken? No 0 Yes 0
a. How will subjects be identified in these recordings?
1) Will data be recorded by audiotape? No 0 Yes 0
Will data be recorded by videotape? No 0 Yes 0
Will photographs be taken? No 0 Yes 0
a. How will subjects be identified in these recordings?
1) Will data be recorded by audiotape? No 0 Yes 0
Will data be recorded by videotape? No 0 Yes 0
Will photographs be taken? No 0 Yes 0
a. How will subjects be identified in these recordings?
a. Explain why it is necessary to record these identifiers.
b. Describe the coding system you will use to protect against disclosure of these identifiers.
c. Describe how subject identifiers will be maintained or destroyed after the study is completed.
3) Where, how long, and in what format (such as paper, digital or electronic media, video, audio or photographic) will data be kept? In addition, describe what security provisions will be taken to protect these data (password protection, encryption, etc).
4) Will you place a copy of the consent form or other research study information in the participant’s record such as medical, personal or educational record? No 0 Yes 0
***If yes, explain why this is necessary.
***This information should be clearly explained in the consent document and/or process.
2) Describe the nature and degree of the risk or harm checked above.
3) Explain what steps will be taken to minimize risks or harms and to protect subjects’ welfare. If the research include protected populations (See Part V, Item 5 above), please identify each group and answer this question for each group.
4) Describe the anticipated benefits of this research for individual participants in each subject group. If none, state “noneâ€.
5) Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks.
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