What risks are present for subjects that participate in

Question

Research questions

What is the prevalence of asthma in Norfolk, Virginia?

Data Collection Instrument Instructions

• Based on your Research Question (s), Specific Aims, and Study Approach, you will design an instrument using the slides from Class 9, 3/29/18 lecture as a guide.

• You will each design a missed methods data collection instrument containing both quantitative and qualitative questions.

• You will decide whether you want your data collection instrument to be primarily quantitative or qualitative.

• For Quantitative studies, a survey or similar data collection instrument with a MINIMUM of 10 items (may have more) is required. You will also include 3-5 open-ended, qualitative questions at the end.

• For Qualitative studies a GENERAL (SEMI-STRUCTURED) INTERVIEW GUIDE of at least 10 questions is required. You will also include an quantitative introductory (3-5 question) set of questions at the beginning. For example, you might ask some demographic questions (age, gender, yes-no questions, how many times.... Etc.)

• For each question, you will briefly tell what research question, aim, or variable you are collecting.

• For primarily quantitative surveys, you will describe how you propose to establish validity (and what type(s) of validity) and reliability(types).

• For qualitative interview guides, you will describe the field notes you will collect in advance to inform the questions. You do not need to discuss validity/ reliability for the introductory quantitative questions preceding your interview guide.

Subject population

Question 1(How will you identify your subjects? How will you recruit?)

Question 2(Who is eligible? List your inclusion/exclusion criteria.)

Question 3(If conducting a retrospective review of records, what are the dates of inclusion?)

Question 4(If using vulnerable subject groups (under 18 or over 89, prisoners, pregnant women, elderly, low income individuals), provide justification for your selection.)

Procedure

Question 1(Provide a step-by-step account of what participants will be asked to do at each stage of your study.)

Question 2(What study tests/procedures will be performed?)

Question 3(If accessing medical records, will you be accessing paper records, electronic records, or both?)

Question 4(If accessing records, where are the records located, and how will they be accessed?)

Question 5(What tools will you use to collect your data (forms, surveys, etc.)?)

Question 6(Exactly what data/variables will you collect? Provide data collection sheets to support your protocol.)

Question 7(Will you be maintaining a link between study records and patient records (such as a list that links a Study ID Number to a subject's name, MRN, etc)?)

Question 8(Will you have access to personally identifying information about your subjects? Who else will have access to this information?)

Risks to subjects/Minimization of Risks

Question1 and 3(What risks are present for subjects that participate in your study?) and (Include risks such as breach of personally identifying information.)

Question 2(How will you minimize these risks?)

Question 4(Where are study records stored? Are they secured? Who has access to them?)

Question 5 (How will you maintain privacy and confidentiality of your subjects and their information?)

Attachment:- Research Guide.rar