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Information and Consent Materials & Normal Educational Practices Discussion

Question Description

2.. Information and Consent Materials (i.e., Consent letter (if paper), email script (for online survey), etc.)

3. If you are using an online survey PROVIDE A FULL CITATION for the instrument and discuss reliability and validity of the instrument. Provide a link to your online version just as participants will see it.. Single line text.

4. Interaction with Research Participants: Will the researcher be collecting data by directly interacting with the participants (electronic, paper, or in person)?

yes / no

19. Interaction with Research Participants: Will the researcher be collecting data by directly interacting with the participants (electronic, paper, or in person)?Required to answer. Single choice.

20.Identifiable Private Information: Will identifiable private information be collected from existing records (i.e., medical records, assessment data)?Required to answer. Single choice.

No

2 – Exemption Categories

Research activities may be classified as exempt when the ONLY involvement of human subjects falls within one or more of the categories below. If any activities do not fit in the categories below, the project is not eligible for exemption. Check one or more of the categories below that apply to the research project.

21.Research involving normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction such as:. Multiple choice.

22.Research that only includes interaction involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following is met:. Multiple choice.

23.Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collected and at least one of the following is met. Multiple choice.

24.Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria are met. Multiple choice.

25.Research and demonstration projects, which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine. Multiple choice.

26.Storage or maintenance for secondary research for which broad consent is required:. Multiple choice.

27.Secondary research for which broad consent is required: Research involving the use of identifiable private health information or identifiable biospecimens for secondary research use, if the following criteria are met. Multiple choice.

The investigator does not include returning individual research results to subjects as part of the study plan. (This provision does not prevent an investigator from abiding by any legal requirements to return individual research results).



28.Background (Why is this important? What problem are you trying to solve?)Required to answer. Multi Line Text

29.Which type of study is this?Required to answer. Single choice.

30.Research questions (at least two)Required to answer. Multi Line Text.

31.Study PopulationRequired to answer. Multi Line Text.

Describe the characteristics of the study population, including the anticipatednumber of subjects, age range, gender, ethnicity, and health status. Specify any inclusion andexclusion criteria.

32.Subject RecruitmentRequired to answer. Multi Line Text.

Describe the process of identifying and recruiting subjects for theresearch activities.

33.Research procedures, consent, data Collection and data AnalysisRequired to answer. Multi Line Text.

Specify the data collection process that will be used. If a survey is sent- who sends it. If data are provided who sends it? If interviews- where and when? This must be clear enough that someone else could follow your steps.How will you analyze your data? For example, how will you measure your independent and dependent variables? What survey items measure the construct and what statistical analysis (if applicable) will you use?

34.Potential RisksRequired to answer. Multi Line Text.

Describe any potential risks that the study poses to subjects, whether seen orunforeseen, including physical, social, psychological, legal, or other risks.

35.Data retention, Records, and Privacy IssuesRequired to answer. Multi Line Text.

Identify the sources of material that will be obtained from subjects, what information will be recorded, concerns relating to privacy of subjects, or confidentiality. (Note: all research-related records must be maintained for three years after the study is completed and these records are subject to audit.)

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