Application for use of Human Participants

Institutional Review Board

APPLICATION FOR USE OF HUMAN PARTICIPANTS
- This application must be completed, reviewed and approved by the Institutional Research Board (IRB) before any research is conducted at Frederick Community College (FCC). The review process will not be initiated until a completed application is on file with the IRB Chair. The IRB accepts only electronic submission.
- Application Date
  
  MonthDayYear
- Project/Research Title
- Principal Investigator
- Phone Number
  Please enter a valid phone number.Format: (000) 000-0000.
- Email Address
  example@example.com
- What is the reason for conducting this research? (MA, Ph.D., Publishing, or etc.)
- Name Institution Affiliated with the Research
- Department
- Faculty Advisor's Name
- Faculty Advisor's Phone Number
  Please enter a valid phone number.Format: (000) 000-0000.
- Faculty Advisor's Email
  example@example.com
- Funding Agency (If Applicable)
- Anticipated Starting Date of Research
  
  MonthDayYear
- Anticipated End Date of Research
  
  MonthDayYear
- What is the level of risk for your project/research?
- *Federal government defines risk as: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk."
- Investigator’s Signature
- Date
  
  MonthDayYear
  Date
- Investigator’s Full Name
- Faculty Advisor’s Signature
- Date
  
  MonthDayYear
  Date
- Faculty Advisor’s Full Name
- Provide an abstract of your research (250 words).
- 1. Purpose of the Study: What are the specific objectives (aims) of the research?
- 2. Investigator experience: Briefly describe the research investigator’s level of experience. Attach an abridged vita highlighting expertise as it relates to this study.
- 3. Background: If your project falls within the “More than Minimal Risk” category:
- a. Provide an evaluative summary of relevant literature on the topic. IF adverse affects occurred, indicate how your research is addressing or attempting to prevent such affects. Include full citations for included research. If possible, also include a copy of relevant articles.
- b. For More than Minimal Risk studies that also include invasive procedures, indicate which databases have been consulted (e.g., Medline). Summarize findings, including findings of adverse affects and steps taken by you to prevent this from occurring in your project. You may reference your response in 3a, as appropriate.
- 4. Subject selection Who will be the subjects? How and from where will they be obtained? What are the criteria for inclusion and exclusion? How will eligibility be determined, and by whom? Will the subjects be selected for any specific characteristics, e.g., age, sex, race, ethnic origin, religion, any social or economic qualifications, or from vulnerable populations include children, pregnant women, or people with intellectual disability?
- 5. Procedures: Describe the study design and all procedures to which human participants will be subjected.
- 6. Data Collection, Storage, and Confidentiality: How will data be collected and recorded? Will it be associated with personal identifiers or coded to protect personal privacy? Where will the data be stored during the study and how will it be secured? Who will have access to the data and/or to the codes? If data with subject identifiers will be released, specify the person(s) or agency to whom this information will be released. What will happen to the data when the research has been completed?
- 7. Risks/Benefits: What potential benefits may participants receive as a result of their participation in the research? What are the potential risks/discomforts associated with each intervention or research procedure? What procedures(s) will be utilized to prevent/minimize any potential risks or discomfort?
- 8. Process of Consent: How and where will the consent process take place? What steps will be taken to avoid coercion or undue influence? Also, enclose the informed consent form, waivers of consent, and the child assent process.
- 9. Location: Where will the study be conducted? If not on campus, what is the nature of your cooperative arrangement with those in charge of the research site? Provide approval documentation from the cooperating institution.
- 10. Independent reviewers: If your protocol is More than Minimal Risk, please list the names and contact information(telephone, e-mail, address) of three experts in your field who can independently evaluate your proposal and assist the IRB at Frederick Community College in the review process.
- The researcher must conduct the research within one year after receiving the approval.
- Shawn Peters
  Director of Institutional Effectiveness
  301-624-2791
  speters@frederick.edu
Frederick Community College
7932 Opossumtown Pike • Frederick, MD 21702
301.846.2400 • frederick.edu

Frederick Community College (FCC) prohibits discrimination against any person on the basis of age, ancestry, citizenship status, color, creed, ethnicity, gender identity and expression, genetic information, marital status, mental or physical disability, national origin, race, religious affiliation, sex, sexual orientation, or veteran status in its activities, admissions, educational programs, and employment. Under the ADA and Section 504, FCC makes every effort to accommodate individuals with disabilities for College-sponsored events and programs. For FCC employees needing accommodations, including interpreting, email humanresources@frederick.edu. For students and others with accommodation needs or questions, call 301-846-2408, or to request sign language interpreter services, please email interpreting@frederick.edu. Sign language interpreters will not be automatically provided for College-sponsored events without a request for services. Requests must be made at least five workdays before a scheduled event to guarantee accommodations. If your request pertains to accessible transportation for a College-sponsored trip, please submit your request at least 21 calendar days in advance. Requests made less than 21 calendar days in advance may not be able to be guaranteed.
frederick.edu/accommodations
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Institutional Review Board