Please provide a brief overall description of the research project. Include information about the background and rationale for the study, its purpose, and objectives.
Briefly describe the anticipated study goal(s).
3. Study Population Details
Please: a) Identify the organization(s) that you are recruiting from. b) Include a detailed inclusion and exclusion criteria. c) Include the total population at each recruitment site. d) Include the total sample size at each site based on the inclusions and exclusion criteria. e) Include the total number of participants needed to complete your study.
4. Recruitment Process
|How will prospective participants be selected, enlisted, or recruited? Explain any criteria being applied for participant inclusion and exclusion from the study. Include copies of recruitment materials (i.e. flyers, email, scripts, etc…) as supplemental documents in your IRB submission. Please also explain: How are you gathering the contact information of your potential participants? Who are you recruiting? How are you recruiting them? Are you conducting a meeting, sending an email, posting flyers?|
How will potential participants receive informed consent? Describe the consent process.
Please include a step by step plan that outlines your data collection protocol. For example: How are you scheduling interviews? How are the interviews being conducted? Where will these interviews be held? How are the participants accessing the survey? How are the surveys being delivered and collected?
Indicate whether or not there are any additional institutions, organizations, or colleges, or IRBs involved in this study. If there are, please list them and describe their involvement in your research plan. If appropriate, include any needed authorizations, permissions, or signed PRN forms for the site(s) in your submission.
Please describe your plan for communicating information between the institutions, organizations, or college campuses including: unexpected problems, protocol modifications, results of the study; security/protection of the data, and how confidentiality or anonymity will be maintained.
Signed consent forms and data, with the exception of transcribed or analyzed recordings, must be stored securely for at least three years after completion of the study. Informed consent documents typically include personal identifiers and a plan should be in place to keep the informed consent documents stored securely and separate from raw data. Please explain how the researcher will maintain and destroy materials. For more information on how to properly manage your data, please read: a) GUIDANCE-Privacy, Confidentiality and Anonymity and b) GUIDANCE-Data Management
Describe the procedures to ensure that information collected for the study will be kept secure, including subjects’ personally identifiable information (PII).
Describe your plans for maintaining personal identifiers securely. How long will the identifiers be associated with the data?
Describe your plans for the destruction of data linkages to personal identifiers and the time frame. If personal identifiers are not associated with the data at any point in the study, please indicate “N/A”.
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