Committee for the Protection of Human Subjects (CPHS Research Proposal) Application for Investigation Involving Human Subjects
A. DATA COLLECTION DATES:
B. Human subjects description:
1. Age range:
2. Approx. number
3. % Male:
4. % Female:
C. Project Summary: (provide 3-5 sentences that give an overview of your proposed study [similar to an abstract])
1. Background and Significance
Provide a brief portion (1/2 page to 1 page in length) of your literature review, to provide a rationale for your proposed study. Include at least 3 citations (in APA format) of your peer-reviewed journal article sources. (Note: You MUST attach a References page to this proposal)
2. Specific Aims
What is your research question? Hypothesis? What are your specific variables, and their levels of measurement (nominal, ordinal, scale/continuous)? Provide an operational definition for your variables.
3. Research Method, Design and Procedures
A. Describe your research methodology and design; Is this an exploratory, descriptive or experimental study? Which specific type of research design are you going to use? What are the specific threats to validity of your study? Explain HOW these are threats.
B. Provide step-by-step description of procedures and how they are to be applied: How are you going to collect your data? How will the data be analyzed (i.e., which statistical test do you plan to use to analyze the data)?
C. What are participants asked to do? When and where are they to participate? How long will it take to participate? Describe type of research information gathered from participants (i.e., data being collected).
Note that ethical responsibility of researcher to participant does not end until participant's information has been destroyed. Research documentation cannot be destroyed for up to three years after completion of a study.
4. Instruments for Research with Human Subject
A. Describe the instruments to be used: What are the constructs your instruments are measuring? How are the instruments scored? What are the strengths and weaknesses of your instrument(s) regarding validity and reliability?
B. Explain how your instrument or specific items on the instrument will answer your research question.
C. If using a previously published scale/instrument, give information about the original author of the scale (full name, agency/university association, email, phone number or physical address), whom you would contact to ask for permission to use for your research.
5. Human Subject Source and Selection Criteria
Describe the procedures for the recruitment of the participants (provide step-by-step detail):
A. Describe relevant characteristics (demographics) of participants in your sample.
B. Where and how participants are drawn for subject selection criteria. Coercion or undue influence needs to be considered and eliminated.
C. The specific random or non-random sampling theory/technique used. Explain how your chosen sampling technique will be carried-out.
D. Criteria for inclusion and exclusion for sample participants, and provide rationale.
6. Informed Consent
A. Describe procedure for obtaining informed consent.
B. Explain how your informed consent and/or assent document is culturally competent.
7. Confidentiality or Anonymity
A. Describe how data will be safeguarded: (a) how confidentiality or anonymity will be maintained; use of personal identifiers or coded data; (b) how data will be collected and recorded; (c) how data will be stored during project; (d) who has access to data or participant's identifiers; (e) who is to receive data, if applicable; (f) what happens to data after research is completed.
Note that research documentation, including signed informed consent forms, are safeguarded for three years after completion of study for federal audit purposes. Faculty sponsors are responsible for safeguarding research documentation completed by students.
8. Research Benefits
Describe any anticipated benefits (direct or indirect) to participants, as well as incentives (if any) for participation.
9. Risks
Describe any foreseeable risks to the subjects, whether physical injury, psychological injury, loss of confidentiality, social harm, etc., involved in the conduct of the research. Explain precautions taken to minimize these risks. Describe the specific contact information of organization(s) for professional treatment that you are going to provide to the participants on the Informed Consent (Note: The researcher cannot be listed as a referral source for intervention in the case that the participant experiences injury or harm).
10. Other Sites or Agencies Involved in Research Project
Indicate specific site if not TSU, e.g., school districts or school, clinics, agencies, etc.
If your proposed research would take place at a location other than TSU, describe how you would obtain permission to conduct study at a partnering location/agency, and describe who you might obtain permission from at that location/agency.