Please read Items 1–4 below before developing your research plan on the following page. These items to be included in your research plan/project summary as applicable.
1. Human participants research:
- Participants: Describe age range, gender, racial/ethnic composition of participants. Identify vulnerable populations (minors, pregnant women, prisoners, mentally disabled or economically disadvantaged).
- Recruitment: Where will you find your participants? How will they be invited to participate?
- Methods: What will participants be asked to do? Will you use any surveys, questionnaires or tests? If yes and not your own, how did you obtain? Did it require permissions? If so, explain. What is the frequency and length of time involved for each subject?
- Risk Assessment: What are the risks or potential discomforts (physical, psychological, time involved, social, legal, etc.) to participants? How will you minimize risks? List any benefits to society or participants.
- Protection of Privacy: Will identifiable information (e.g., names, telephone numbers, birth dates, email addresses) be collected? Will data be confidential/anonymous? If anonymous, describe how the data will be collected. If not anonymous, what procedures are in place for safeguarding confidentiality? Where will data be stored? Who will have access to the data? What will you do with the data after the study?
- Informed Consent Process: Describe how you will inform participants about the purpose of the study, what they will be asked to do, that their participation is voluntary and they have the right to stop at any time.
2. Vertebrate animal research:
- Discuss potential ALTERNATIVES to vertebrate animal use and present justification for use of vertebrates.
- Explain potential impact or contribution of this research.
- Detail all procedures to be used, including methods used to minimize potential discomfort, distress, pain and injury to the animals and detailed chemical concentrations and drug dosages.
- Detail animal numbers, species, strain, sex, age, source, etc., include justification of the numbers planned.
- Describe housing and oversight of daily care.
- Discuss disposition of the animals at the end of the study.
3. Potentially hazardous biological agents research:
- Give source of the organism and describe BSL assessment process and BSL determination.
- Detail safety precautions and discuss methods of disposal.
4. Hazardous chemicals, activities & devices:
- Describe Risk Assessment process, supervision, safety precautions and methods of disposal.
- Material Safety Data Sheets are not necessary to submit with paperwork.