Use this template to provide a description of your research proposal. All applications for review should contain at least the following information. Please be sure to include a version number and/or date on your proposal. It can be done in the footer as seen below.
II. Investigators (including co-investigators) and their institutional affiliations
List all investigators (including the Principle Investigator (PI), Co-Investigators (Co-I)), credentials, and primary affiliation or employer (Seton, UT-Austin, UT Dell Medical School, community, other).
III. Sponsor/source of funding
IV. Hypothesis, research questions, or goals of the project
V. Background and significance
Describe relevant background literature to support the rationale for doing this study. This rationale should provide sufficient information to justify the study. It should be limited to no more than two to three pages. Cite appropriate references & list at end of proposal.
VI. Research method, design, and proposed statistical analysis
Provide a brief overview of your research methodology and design. Discuss your proposed analysis of the research data.
VII. Human subject interactions
- Identify the sources of potential participants, derived materials, or data. This includes data obtained solely from medical records or other patient-care data bases. Describe the characteristics of the subject population such as their anticipated number, age, sex, ethnic background, and state of health. Please describe whether some or all of the participants are likely to be vulnerable to coercion or undue influence, and if so, what additional safeguards are included to protect their rights and welfare. Identify the criteria for inclusion and/or exclusion. Explain the rationale for the use of special classes of participants whose ability to give voluntary informed consent may be in question. Such participants include students in one’s class, people currently undergoing treatment for an illness or problem that is the topic of the research study, people who are mentally retarded, people with a mental illness, people who are institutionalized, prisoners, etc. When do you expect human subject involvement in this project to begin and when do you expect it to end?If some of the potential participants or the parents of child participants are likely to be more fluent in a language other than English, the investigator must assure that proper procedures are followed in the consent process to assure that the person giving consent is fully informed. (See SIRB policy on Obtaining and Documenting Informed Consent of Participants Who Do Not Speak English).
- Describe the procedures for the recruitment of the participants. Copies of fliers and the content of newspaper or radio advertisements must be provided to the IRB. If potential participants will be screened by an interview (either telephone or face-to-face), provide a script of the screening interview.
- Describe the procedure for obtaining informed consent. If you do not plan to obtain active written consent, specifically point this out and explain why not. Copies of the consent form(s) must be provided to the IRB for review. Children (people under 18) need parental consent to participate in studies. Participants between 7 and 17 should be given an opportunity to assent to their participation. (See Sample Assent Forms for Children).
VIII. Research protocol
What will you ask your participants to do? When and where will they be participating? How long will their participation be? What interventions or procedures, if any, will be done for the research? Who will implement these procedures?
If this study involves data collection, describe the type of research information that you will be gathering from your subjects (i.e., the data that you will collect).
Copies of all surveys, testing materials, questionnaires, and assessment devices must be provided to the IRB for review. Copies of topics and sample questions for non-structured interviews and focus group discussions must be provided to the IRB for review. For studies that will include data collected from medical records or patients’ charts, copies of the data collection sheet must be provided to the IRB for review.
Please include a timeline of important study events. This should include, but is not limited to, day/month you expect to recruit first participant, dates of important milestones throughout the project, day/month you expect to recruit final participant, as well as the approximate schedule for data analysis and when you expect to no longer need access to participants or protected health information (PHI).
X. How will you protect the privacy and confidentiality of participants?
Please note the two terms are different and should be addressed individually. Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality pertains to the treatment of information or data that an individual has disclosed in a relationship of trust with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure. Remember ensuring privacy of participants is different from maintaining confidentiality of data.
Discuss the procedures that will be used to maintain the confidentiality of the research data. Specifically, how will data be stored to ensure that it is secure and remains confidential? How will the investigator handle that data? For data obtained from medical records or patients’ charts, describe the procedures you will follow to either code or de-identify the data.
If the subject’s responses are taped and the tape can be linked to a participant because his or her name is on an audiotape or because the tape is a videotape, precautions must be taken. These safeguards include storing the tape in a secure place (file cabinet in a locked office), limiting access to the tape to the researcher and his or her associates, and destroying the tape, if it is reasonable to do so, after it has been transcribed or the information on it has been coded. Describe the disposition of the tapes in the consent form. If the tapes are to be retained after the study is completed and they have been analyzed, explain the rationale for doing so in the proposal and state that they will be retained in the consent form.
XI. Describe your research resources.
Discuss the staff, space, equipment, and time necessary to conduct research and how these needs are met. Include a description of the proximity of any resources such as emergency facilities, emergency care or medical/psychological care, and/or any support services, if applicable.
XII. Describe any potential risks (physical, psychological, social, legal, loss of confidentiality, or other) and assess their likelihood and seriousness.
Describe alternative and potentially less risky methods, if any, that were considered as possible methods and why they were not used. If the research methods impose risks on the subjects, include evidence that may justify their use (such as previous experience with the procedures). Most studies pose some degree of risk, even though the risk may be minimal. For example, one common risk is the loss of the confidentiality of the participants’ responses/data.
One risk that may arise in studies with children or interviews with parents about their children is the risk that you may acquire information about familial child abuse. If you acquire this information, you are required to report it to Child and Family Protective Services, 1-800-252-5400. If your study is likely to result in responses that may suggest child abuse and you do not provide anonymity to the respondents, you must inform the parents in the consent form (and the child in the assent form) that you are legally required to report this information. Research data can be subpoenaed by a court of law, so questions about illegal activities such as drug use place respondents at risk unless the participants’ responses are anonymous. A Certificate of Confidentiality can eliminate the risk of having one’s data subpoenaed.
Describe the procedures for protecting against (or minimizing) any potential risks and include an assessment of their effectiveness. For all research involving human subjects research, you should understand what is meant by an “unanticipated problem” or adverse event in relation to your study. Note that you are required to report adverse events to the Ascension Seton IRB office within 24 hours of notification of the event by contacting the Office of Research Facilitation (ORF). A message can be left for after-hours and weekend events. The investigators must follow-up the message by submitting the Local Adverse Event Report Form within 3 working days of notification of the event.
In some cases, studies that are greater than minimal risk, involve greater than minimal risk interventions or devices, include vulnerable populations, your sponsor and/or the IRB will require inclusion of a data safety monitoring plan (DSMP).
If the study involves a procedure that introduces a physical risk, specify arrangements for providing medical treatment if it should be needed. If the study involves a procedure that introduces a psychological risk, such as the recall of a traumatic event, specify arrangements for providing psychological treatment if it should be needed. Please state whether or not you will provide payment for physical or psychological harm if it is incurred.
XIII. Describe and assess the potential benefits to be gained by participants (if any) and the benefits that may accrue to society in general as a result of the planned work.
Discuss the risks in relation to the anticipated benefits to the participants and to society.
XIV. Indicate the specific sites or agencies involved in the research project.
Demonstrate that PI has the resources and facilities necessary to conduct proposed research. These agencies may include school districts, day care centers, nursing homes, etc. Include in your IRB application, approval letters from these institutions or agencies on their letterhead. The letter should grant you permission to use the agency’s facilities or resources; it should indicate knowledge of the study that will be conducted at the site. If these letters are not available at the time of IRB review, approval may be contingent upon their receipt.
XV. If the project has had or will receive review by another IRB, indicate this.
Provide the IRB with a copy of this approval.