Need help writing a study summary?

Background and Introduction.

Identify the research area being studied and provide a review of the literature that provides the basis for understanding the objectives of the study.

Describe how this study contributes to existing knowledge. Remember to spell out acronyms the first time they are used. The answer does not need to be lengthy and it should be explained so that an “educated non-expert” can understand. Be sure to use consistent terminology and be sure to check your grammar.

This review should be written such that scientists outside the investigator’s area of expertise can understand the issues involved.

Any information about previous research related to this study involving animals and/or humans should be summarized. Include studies on pregnant animals if the research is conducted on pregnant women, fetuses, or neonates.

Always cite and include references.

Objectives, Research Problem, Research Question, and Hypothesis(es)

The objectives should be stated in such a way that the reader can determine the appropriateness of the study design below. The “Research Question” is the question that you are trying to answer when you do research on a topic or write a research report. It should be as specific as possible. In some cases, you may make two or more research questions to cover a complex topic. Use appropriate punctuation (question format).

If appropriate, state the specific hypotheses being tested and/or study aims.

Participant Selection Criteria.

Who do you hope to recruit? And, how many? For preexisting data, how much/many will you collect? And, from whom/where?

Participant-entry criteria should be as detailed as necessary to define the sample population under study and, for clinical studies, to reduce confounding treatments or diseases.

Precise criteria for age, gender, or any other factors (e.g., in a clinical study: diagnoses, extremes in signs or symptoms, etc.) should be included. Specific exclusion criteria should be listed which could interfere with the study or which place participants at risk during the study. What are your criteria for excluding someone from participation? And, who will you include? Are any criteria based on age, gender, race, ethnicity, sexual orientation, origin, type and stage of disease, the subject’s previous treatment history, and the presence or absence (as in the case of the “healthy” or “control” subject) of other medical, psychosocial, or emotional conditions. If so, justify. For example, if you are doing a study on pregnant persons, will you exclude men (most likely, you will)?

Keep in mind a representative and equitable sample, and state rationales as to the eligibility requirements.

Design/Methodology.

A simple statement of the design methodology proposed to test your hypothesis(es) should be included.

The IRB will need to know where the research is being conducted, how participants will be recruited and how you are going to conduct the study. The methods section of a research proposal contains details about how you will conduct your research. It includes your study design – the methodology and methods that you plan to use – as well as your work plan – the activities that you plan to undertake to complete your project. Describe the details of the procedure(s) to be used; how the data will be collected and/or what will be done to collect the needed data and when the data will be destroyed.  The methods section of a research proposal must contain all the necessary information that will facilitate another researcher to replicate your research. The purpose of writing this section is to convince the funding agency that the methods you plan to use are sound and this is the most suitable approach to address the problem you have chosen. You must also demonstrate your understanding of alternative methods to show that you have made a sound and well-calculated judgment. The methods section of your research proposal should answer the following questions:

What is your study design and why did you choose it?

Is the study qualitative or quantitative?

What are the methods you will use to collect data?

Who will be the participants of your study?

What procedures/activities will the study involve?

How long will the experiments/study take to get completed?

Randomization and control methods should be stated.

Of primary importance is clearly showing how the trial design will collect the study data and lead to the analysis and interpretation proposed. Any interim analysis or criteria for stopping a clinical trial should be stated.

For studies not proposing experimental design include detail about the scientific methods to be employed.

Study Procedures.

This section of the protocol should state both the chronological flow of the study and the procedures/activities that the participants must undergo. The investigational activities, treatments, or procedures must be clearly detailed as to how and when they will be performed. For clinical studies, a distinction should be made between the procedures for treatment evaluation versus procedures for safety evaluation.

Treatment endpoints must be defined as well as interim procedures for dealing with adverse events. Schematic diagrams may be helpful for understanding the flow of a study.

• Standard of Care vs. Research-Related Procedures. If applicable, please separate and explain what proposed procedures for this study are considered standard of care and which ones are strictly research-related.
• Data and Safety Monitoring Plans. The information provided to the IRB should describe the process and mechanisms in place for assuring 1) the oversight of data integrity, and/or 2) the safety of research participants.

Statistical Methods, Data Analysis, and Interpretation.

The anticipated methods to be used for analysis and interpretation of the data should be stated.

Naturally, these methods must compliment the design of the trial and the nature of the data which are being collected. The factors in the trial that determine the proposed sample size (e.g. power) should be stated.

Administrative Responsibilities.

Specify the resources available to conduct the research including qualified personnel, equipment, space, and what facilities will be involved.

Include an explanation of the methods for maintaining confidentiality of the study data.

Oftentimes, the PI gives access to data to co-PIs/key personnel. The IRB needs to know who, if any, is managing access to the data. Is it only the PI who gives access? Or, are there others who make that decision on behalf of the research team?

Recruitment.

If applicable, describe methods of participant recruitment which will be used to recruit participants such as newspaper/internet advertisements or flyers. Include who and how many participants will be recruited and upload any recruitment materials. Describe in detail the process to be used to recruit participants. Upload scripts, emails, letters, advertising and all marketing materials with your application. Provide a step-by-step description of how potential participants will be recruited for the study.

Attach all recruitment materials to the application for review.

References and Appendices.

If you are writing a proposal for eventual publication, presentation, or for a class, you will need references.

Citations from the literature should be included in the Background/Introduction section of your written proposal and the references listed.

Other supporting information, such as your own publications, should be submitted if you feel it would allow a deeper understanding of the project.

Risks and Benefits.

Explain how likely or serious each of the risks are, and if possible, what steps you still take to minimize them, including how to address any negative impacts that do happen to occur during or after participation.

There are risks to ALL research, even if the risks are no greater than what is experienced in daily life. All possible risks should be spelled out as well as how you will mitigate those risks. The risks on the IRB application must match what is written on the consent form, except that here they are written to the IRB reviewer.  Describe any potential risks to the dignity, rights, health or welfare of the human subjects and how these will be mitigated. Risks may be physical, psychological, social, legal, economic, to reputation, or others. All other possible options should be examined to minimize any risks to the participants.

Plans for Multi-Center Studies

If you are utilizing multiple sites around the city, state, nation, or world with a PI other than the local PI designated at each site, you need to communicate the following:

If you are the lead investigator for this study, or Utah Tech University is the lead site for this study, please describe the management and communication among sites of information obtained in this research that may be relevant to the protection of research participants, such as: unanticipated problems involving risks to participants or others, interim results, and protocol modifications.

Please attach an IRB approval from each participating site to the Documents and Attachments page of the application under “Other Documents”.

If the site does not have its own IRB of record, please contact the IRB for assistance.

Please include contact information (address, phone, and email) for each participating site. This can be attached separately to your application.