Instructions for Expedited and Full Review Application Form

Tulsa Community College Institutional Review Board (IRB)
 

The application must be typed using a font no smaller than 11-point.

Cover Page

Principal Investigator (PI) Information: Provide the requested information (name, phone, status, email, and address) of the individual with primary responsibility for the project. If there is more than one PI, one must be designated here as the primary / contact PI. All IRB correspondence will be sent to this PI, who will be responsible for sharing IRB communications with other members of the research team.

Title of Study:  The title of the study should be listed here.

Student Information:  If the PI is a TCC student, provide the college wide ID #, the department, campus, and the name and email address of the research advisor.

Estimated Start and End Date of Study: Research projects that involve human participants must be reviewed by, and receive approval from, the IRB PRIOR to initiation. 

Type of Project:  Mark the appropriate box(es).

Signatures:

  • Principal Investigator (PI): The PI is the person with primary responsibility for the research project.
  • Faculty Research Advisor: This signature line is required only for student research. Signature certifies that the faculty member has read, reviewed, and approved the content of the application and is responsible for the supervision of this research study.
  • Academic Administrator: This signature certifies that the administrator has read, reviewed, and approved the content of the application. The academic administrator is generally the department chair, directors, or associate dean.

Criteria for Exemption Status

If your study meets one or more of the exemption criteria listed on the application form, mark all that apply and complete the exempt application form.  Complete the IRB application form for expedited and full review studies if none of these apply.  If you have any questions or want more detail about the exempt categories, you may refer to the 45 CFR 46.101 which can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm or contact the IRB.

Methodologies

1.   Describe the purpose of study, including research questions and/or hypotheses.

List the broad, long-term objectives and the goal of the specific research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology. For thesis or dissertation research, the purpose stated in the prospectus should be used.

Define any unusual terminology in layman's terms so that the reviewers will understand what is being studied.  Spell out and clarify any acronyms that will be used.

2.     Participant information:

a.    Describe participants in study: Provide a general narrative description of the participants.

b.    Provide the approximate number of participants you plan to include in your study.

c.     Identify any vulnerable populations that will or may be included in the study.

d.    List the age (or age range) of participants (e.g., 18 years and up; 14 year olds; 60 - 70                                                                                 years of age). Provide the rationale for inclusion / exclusion on the basis of age.

e.    Provide the sex of participants. Provide the rationale if you are including or excluding participants on the basis of sex.

f.     List and provide rationale for any other inclusion/exclusion criteria that will be used to select research participants.

3.     Describe the participant recruitment process in detail. Attach any recruitment materials or scripts.

Consider the following when stating the recruitment details:

  • If using any type of list to contact potential participants, how will you obtain this list and from whom or where will you obtain it?
  • Is anyone involved in the recruitment process that is not part of the research team? If yes, explain who this person is, their relationship to the participants, and their role in the recruitment process.

4.   Describe in detail the research procedures. Answer the 3 questions (a, b, and c) regarding the use of video, audio, and/or internet media.

Describe step-by-step the process that will be used for this research study. This section should explain the steps of the research chronologically and in detail. Explain what the research participants will be expected to do or what intervention will be used and what will be done to them. It should be written so that an educated layperson can understand the terminology. It is crucial that sufficient detail is provided in this section in order to give the committee a clear picture of the study.

The following statement is required in the risk section of the application and on the consent document "There is a potential risk of loss of confidentiality in all email, downloading, and internet transactions."

5.   What is the time commitment for the participants?  Include the number of sessions, maximum time commitment per session, and the maximum cumulative time commitment.

Consider the following when describing the time commitment for each procedure:

  • How long will it take the participants to complete any interviews or written / on-line instruments (e.g., demographic questionnaires, surveys, evaluations)?
  • If the study involves multiple sessions over a period time, provide the number of sessions, the length of each session, and the schedule of these sessions. Calculate a total amount of time that these sessions represent.
  • If participants are traveling from a distance to participate, include this as part of the time commitment.
  • Assure the committee that procedures will be in place for breaks if needed based on length of sessions, needs of participants, etc.

6.     Site / location of the study.

  • Explain the physical location (i.e. library within hospital, conference room at clinic, school classroom, meeting room at church, restaurant, e.g.). Describe the privacy arrangement (i.e. one-on-one, group, proximity of other individuals, etc.).
  • If the study will take place at a specific agency or organization, provide the following:
  • Name of site
  • Affiliation of Principal investigator with this site, if any
  • Affiliation of participants with this site
  • Description of any privacy issues such as proximity to other individuals and how these issues will be handled.
  • The IRB requires a letter from all study sites on official letterhead and signed by an agency official stating that the research may be conducted on the premises. If an approval letter is not included with this application, explain. The IRB may approve a study prior to receipt of the letter, but no data may be collected at the site until the letter is received.

7.     List all potential risks to participants and the steps to minimize these risks. Consider the vulnerability of the population you are studying when completing this section. This information must exactly match the risk information in the consent form.

  • Risks to participants can include, but are not limited to:
  • Loss of confidentiality (this risk exists in most studies)
  • Possibility of embarrassment
  • Physical or psychological harm
  • Physical or emotional discomfort
  • Fatigue
  • Loss of time
  • Monetary loss (transportation, time off work, etc.)
  • The administration of drugs or radiation
  • Unusual physical exertion
  • Subjection to deceit
  • Public embarrassment and/or humiliation
  • Topics of a sensitive nature
  • Anxiety
  • Harassment
  • Invasion of privacy

 

  • To minimize the risks of fatigue or discomfort, assure participants that they can take a break or stop the study at any time.
  • If there is a possibility of emotional discomfort or psychological harm, provide all participants with a referral list of agencies that can be contacted for assistance.
  • If using email or internet as a way to communicate with participants or obtain data, add the following statement, "There is a potential risk of loss of confidentiality with any email, downloading, and internet transactions" to the cover letter or consent form.

8.     Will participants be told about the intent of the study prior to participating?

This section must be completed. Initially withholding the intent of a study from participants is considered to be deceptive. If participants will not be informed of the intent of the study before it begins, provide a detailed explanation of the need for this deception, how the participants will be briefed on the intent after the study, how participants' questions will be answered, and how participants will be informed of the option to allow or disallow the use of their data in the study.

9.     Describe how, when, and in what format (verbal, cover letter, consent form) participants will be informed of their right to ask questions at any time during the study.

The participants must have the opportunity to ask questions. This can be done in a variety of ways and at different times such as:

  • during the interview or session
  • during recruitment
  • when the researcher is explaining the intent of the study
  • when the researcher is explaining the consent form

Explain here how the participants will be made aware that they may ask questions at any time throughout the study and explain when and how they may do so.

10. Identifiable data

This question addresses how identifiable data will be handled. Identifiable data include documents, audio and video recordings, electronic data, and blood or other human specimens where the participants can be identified.

a.    What type of identifiable data will be collected? Examples of identifiable data include surveys with identifying information, information from medical or school records, etc.

b.    Where will this data be stored? Describe the exact location, storage arrangements, and the security measures that will be in place (i.e., locked cabinet in office, password protected computer in the lab, etc.). Use caution when storing data electronically, especially when storing the data on a laptop or flash drive. This includes the storage of digital audio or video recordings.

c.     What is the exact date that study data will be destroyed? If data will be retained indefinitely, explain why and include the explanation on the consent form.

d.    How will the identifiable data be destroyed on the specified date? Hardcopies of any collected data with identifiable information should be shredded. Electronic data should be deleted or destroyed in a manner that insures the information cannot be retrieved.

e.    Because the academic component of TWU is classified as a non-covered HIPAA entity, identifiable health or health-related data cannot be transmitted electronically. Health-related data is data that would be found in a medical record. You must be able to answer "no" to at least one of the questions listed in order for your study to be approved. If you must answer "yes" to all three of these questions, then appropriate TWU administration will be contacted regarding the feasibility of conducting the study.

BENEFITS/REMUNERATION

11.  What will the participants receive?

Explain what the participants will receive as a result of participating in the study. If providing monetary remuneration such as cash, gift cards, entry in a drawing for a prize, explain the conditions that must be met to receive the remuneration (example: participants will receive $10 for completing the initial survey and $25 for participation in all subsequent study activities). Detailed information about remuneration and benefits must be on the consent form.

12. Generalizable benefits

Explain what the general benefits of the study are (e.g., this information could further the understanding of how or why certain concepts should or shouldn't be used, the results could assist administrators to develop a curriculum for schools in rural areas, the results will contribute to the body of knowledge in a certain field)

13. Results of the study

Explain whether or not the results of the study will be accessible to all research participants or if the participants must request the results. If the results will be provided, explain how this will occur. If the results are not going to be provided to the participants, explain why.

14. Written informed consent

A consent form is necessary for studies in which risks are more than minimal and/or when minors are participants. This section should describe the process that will be used for obtaining informed consent, including where and when the consent form will be signed, how the participants will have the opportunity to discuss the information on the consent form with the researchers, etc.

Instructions for developing a written consent form can be found in the Guide to Writing a Consent Form.

The consent form must be consistent with the information provided to the IRB in the application.  Especially make sure that the title on the consent form matches that on the application form, that the risks in the application are also included on the consent form, etc.

15. Detailed rationale for not using written informed consent

As required by federal guidelines, barring certain exceptions, no investigator may involve a human being as a participant in research unless the investigator has obtained the legally effective informed consent of the participant or the participant's legally authorized representative. The IRB may waive the requirement for the investigator to obtain a signed consent form if it determines that:  (1) the only record linking the participants and the research would be the signed consent form and the risk of potential harm resulting from a breach of confidentiality would be high (e.g., individuals participating in a study of HIV/AIDS, sexual behavior, family violence, etc.); or (2) the research presents no more than minimal risk of harm to participants and involves no procedure for which written informed consent is normally required outside of the research context.

If written informed consent will not be obtained, use this space to explain how consent will be obtained for the study. For example, if an anonymous questionnaire or survey is to be used, the following statement may be placed at the top of the survey, "The return of your completed questionnaire constitutes your informed consent to act as a participant in this research."

16. Research team members

List all research team members including the PI, the research advisor if the PI is a student, all Co-PIs, research assistants, research staff, and any other research team member who will have direct contact with the participants or access to identifiable data from participants.

17. Attachments

List and describe all forms, scripts, flyers, consent forms, agency approval letters, signed confidentiality agreement forms, referral lists, surveys, questionnaires, or any other instrument used in the study.

  • Attach copies of all items in this list
  • If an item is exceptionally lengthy, contact the IRB to request a waiver of this requirement.
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