Instructions for Exempt Application Form

Instructions for Exempt Application Form

 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 TTC 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://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm or contact the IRB.

Methodology

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.     Mark any vulnerable populations to be used (check all that apply).  All local, state, and federal laws must be considered when working with any vulnerable populations. If using minors, consider the federal mandate to report child abuse.  According to the Texas Family Code, anyone, including individuals conducting research, must report known or suspected child abuse.  Report child abuse by calling the Child Abuse Hotline at 1-800-252-5400 or your local law enforcement office.  All researchers conducting expedited or full review studies must include the following statement in their consent form: "Confidentiality will be protected to the extent that is allowed by law."

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.     Will participants be excluded based on ethnicity?  If yes, you must explain the criteria to be used and provide the rationale for using these criteria.  If using non-English speaking individuals, make certain that issues regarding the translation of documents provided to participants are addressed throughout the application (specifically the questions regarding the instruments and consent form). Describe how the documents will be translated, the language(s) of the translations, and the qualifications of the translator.

g.    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?
  • Will you use written materials for recruitment (e.g., flyers, brochures, letters, email)? All written materials must include the PI's name and contact information, the title of the study, a statement that participation is voluntary and that participation maybe discontinued at anytime.
  • Will the participants be recruited via face-to-face contact? Describe the location and setting where recruitment will take place. The IRB requires a written version of the script to be used.
  • How will participant contact be made? (e.g., Will PI or another member of research team contact the participants? Will the participants contact the PI? What method will be used to make this contact?)
  • Is anyone involved in the recruitment process who 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.

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.

If you will be video or audio-recording, explain the purpose of the recordings and who will have access to the recordings. If the recordings will be made publicly available for any reason, this must be disclosed in the consent form and participants must be allowed to specifically consent to this use. If applicable, explain how confidentiality of non-consenting individuals in the recording will be maintained. If the recordings will be digitized, explain the security precautions used for these digital files.

If you will be using e-mail and/or internet, provide a detailed explanation of how it will be used. Explain how access to email lists, listservs, or web postings will be obtained. If using a server, the IRB will need assurance that the data will be secure. This includes encryption methods, data retrieval and data storage information. If you are downloading survey information that is identifiable, the method you use to retrieve the data should encrypt the information. When using any internet tools caution should be taken to ensure that the data requested are not identifiable.

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.

For example, Dr. Smith is conducting a study with classroom children. Each child will be pulled out of class and receive special instruction two times per week for 1 hour each time for 12 weeks. Therefore, the total time commitment for this child to participate in the study would be 24 hours (1 hour x 2 sessions per week x 12 weeks = 24 hours).

  • 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.

Exempt studies should pose little risk. If more than minimal risks are listed, the IRB may require an expedited or full review.

8.     HIPAA

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 TCCU administration will be contacted regarding the feasibility of conducting the study.

9.   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.

10.  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.

TCC