Instructions

All research projects conducted at HealthPartners must be approved by the appropriate subcommittee and by the HealthPartners Institutional Review Board or Animal Care and Use Committee. To start the process, the Application to Conduct Research must be completed.

There are separate applications for each type of study:

          Clinical Research (direct intervention with patient care),

          Health Services (care improvement using data, surveys, interviews etc.)

          Exemptions – category 1 & 2, (surveys)

          Exemptions – category 4 (retrospective review of data/specimens)

          Exemptions – release and/or use of coded or de-identified data or specimens

          Animal Studies

The Clinical and Health Services application forms can be used to apply for Full IRB Review or Expedited Review. These forms may not be used to apply for exempt research status. (Need help deciding which level of review is appropriate for your research? Contact the IRB Office, 651-254-3391.)

The application contains three sections:

• Part A, General Information and Required Signatures;
• Part B, Science and Merit;
• Part C, Human Subjects Protections. 

The application form is available at the end of these instructions. The form runs in Microsoft Word and contains fields that you need to complete. To move from field to field, use either the tab key or click the field with the left button of your mouse.  

How to complete an application form prior to review

1. Make sure you are completing the most updated version of the appropriate form from this website.
2. All application forms must be typed.
3. Fill out all of the questions completely. (If there are questions about using the text form fields or checkboxes, please contact Research Administration at 651-254-2928).
4. Make sure to include the e-mail addresses of the PI and Co-investigators.
5. Fill out and attach the appropriate appendices required by responses in this application.
6. Remember to attach supporting documentation: consent form(s), assent form(s), protocol, survey instruments, interview schedules, solicitation letters, advertisements, etc.  If there are items to come at a later date, please state this information in the application.
7. Complete the checklist that accompanies each form to ensure all requirements for submission are completed so that review is not delayed.
8. Submit the application and appendices along with the supporting documentation to researchapp@HealthPartners.com.

APPLICATION FORM

Part A, General Information and Required Signatures

Title:

A good title is brief (up to 3 lines or up to 325 characters and spaces), clear and distinguishable from previous studies on the same topic. If appropriate, include pilot or feasibility in the title. Please do not exceed 325 characters or spaces, as it will cause problems on the bottom of the form. If you are having trouble cutting a long title down to three lines, feel free to repeat the full title in the lay summary.

Pilot/Feasibility Checkbox:

If the project is a pilot or feasibility study, it is suggested that you include “pilot” in the study title.

HP PI:

The Health Partners Principal Investigator is the Health Partners employee who is responsible for all research activities. All projects must have a HealthPartners investigator working on the project.

Overall Principal Investigator:

If the study is in collaboration with another organization and the Principal Investigator is not the HP Principal Investigator, provide that person’s name, organization, address, and phone numbers.

Contact Person:

A person (other than the PI) at HP who is familiar with the study details and can assist the research administrative staff in the event that the HP Principal Investigator is not available as needed.

Timing:

Note the proposed start date and the duration (i.e.: 9 months, 1 year, 18 months, 5 years, etc.) of the project.

Total Subjects This Site:

Indicate the total number of subjects to be recruited at this site.

Total Subjects:

If this is a multi-center study, list the total number of subjects to be recruited from all sites.

Funding Information:

Funders: If there are more funding sources than space allows, record the primary sources and include a full description in the Resources and Expenses section of the application.

Lay Summary:

This summary is limited to the space remaining on the first page of the application and is restricted to 1204 characters and spaces or about 12 lines of text. Anything beyond the space provided will be deleted. This summary must include a brief description of the project purpose and methods.

Funding & Grant Information:

Complete this section as indicated.  This information is useful for research administration and the review committees to better understand the research.

Personnel

List all study personnel as well as their associated department or work location. List external investigator level personnel. Obtain the signature of the person responsible for approving your departmental budget.  This may the person that has authorized you to spend time on this project.  Indicate that you have also sent a copy of the application to your department head by inserting the department head’s name and name of department.

Financial Interests Disclosure

Financial interest or no financial interest must be indicated for all key personnel. Key personnel are defined as, and should be limited to, individuals who contribute in a substantive way to the scientific development or execution of the project.

It is the policy of HealthPartners Research Foundation that any person engaged in the design, conduct or reporting of a research project must disclose significant personal financial interests related to the project, or to the sponsor of the project or the sponsor’s affiliated entity(ies).  If the Foundation determines that such an interest might reasonably appear to directly and significantly affect the project, the Foundation will take steps either to eliminate, manage or reduce the financial interest conflict.

This policy applies to any researcher, physician, IRB member or research committee member or employee responsible for the design, conduct or reporting of a research project at HealthPartners facility sponsored by the government or private industry, including HPRF as well as persons engaged in the administration of a research project such as research committee members and the Research Management Team.

All financial disclosures must be updated by the researcher during the period of the project as new reportable Significant Financial Interests are obtained.  Researchers have a continuing obligation to scrutinize any transactions in which they are involved for potential conflicts and to disclose per the policy below.

For more information see the Objectivity in Research Policy.

Part B, Science and Merit Instructions and Examples

The ten sections included here correspond with the criteria used to evaluate your proposal.  Each section should provide sufficient summary information for a reviewer to determine whether the review criteria have been met. Part B should be a maximum of twelve pages.

Main Research Question Or Hypothesis And Specific Aims

State precisely what the research described in this application is intended to accomplish. State the specific aims of your study (an aim is a specific, measurable outcome) and the overall research question and/or a testable hypothesis.

Background & Significance - Approximate length: 2-4 pages

• State the importance of the research described in this application to the scientific community and to HealthPartners. Briefly identify the specific knowledge gap that the project is intends to fill.  Describe the effect on the concepts or methods that drive this field. Include a brief review of past research in this area. Attach your literature citations at the end of the Science and Merit form.
• Describe any preliminary results you may have that support your proposal. If this is a continuation of a previous study please include a progress report.

Impact

Provide information as to how the results of the study could impact the health of HealthPartners members and the community; include plans to disseminate the results in the public domain and to translate the results of the study into care within the HealthPartners’ system and for HealthPartners’ personnel.  All research conducted within HealthPartners Research Foundation is intended for publication. We encourage investigators to begin developing their publication and translation plans early in the development of the project.  Please outline how you will communicate your results within HealthPartners as well as possible publications and target journals for this study.

Approach

Some questions in this section will not apply to all study designs.  In this case, you may indicate “N/A.”  A thorough response in this area will better inform the reviewers and decrease the delays in approval due to incomplete applications.

Methods

Briefly summarize the conceptual framework, experimental design, methods, and the procedures to be used to accomplish the specific aims of the project. Please include specific information about what tasks you will accomplish when doing the study. Describe the protocols to be used and a tentative sequence or timetable for the investigation. Include a discussion of the kinds of data you expect to obtain, and specify the validity and reliability of data collection instruments to be used. The data to be collected and justification of its use should be clearly stated. Describe any new methodologies and their advantages over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.  Point out any procedures, situations or materials that may be hazardous to personnel, and the precautions to be exercised. Attach as Appendices, any questionnaires, surveys and/or data collection instruments to be used in the study.

• Analysis

Begin this section with a brief restatement of the primary hypotheses that will be tested. For each hypothesis, state the variables that will be included in the analysis (dependent/outcome, independent/predictor, and covariates), ensuring that it is clear whether each variable will be considered binary, categorical, or continuous in the analysis. Describe the statistical methods that will be used to test each hypothesis, including an explanation of their appropriateness. Finally, please describe how the results of the analysis will speak to the objectives of the study. Statements such as "appropriate analyses will be performed" or "a statistician or data analyst will be hired" and naming the statistical software package to be used do not provide sufficient information for review.

Example 1:

The primary hypothesis to be tested states that there will be a higher 24-hour survival rate in the experimental treatment group relative to the standard treatment group. The primary and secondary outcomes of interest are binary (i.e., yes/no, success/failure) and will be explained by treatment group (experimental, standard) with age (grouped into quartiles), gender (male, female), and whether the heart attack was witnessed (yes, no) as covariates. The primary hypothesis test will be performed using logistic regression analysis or the Cochran-Mantel-Haenszel test for the common odds ratio with emergency units as strata. This will allow us to test whether the relationship between treatment group and the binary outcome variables is significant while controlling for other factors. It is expected that the odds ratio predicting “yes” or “success” outcomes from treatment group will be significantly greater than 1.0 and indicate that the experimental group has a higher rate of success outcomes than the standard treatment group, controlling for age, gender, and whether the heart attack was witnessed.

Example 2:

The primary objective of this research is to obtain preliminary data speaking to women’s satisfaction with outcomes following a hysterectomy. Descriptive statistics will be computed for satisfaction ratings (1=not at all satisfied, 5 = extremely satisfied), including measures of centrality (mean, median) and dispersion (minimum, maximum, interquartile values, standard deviation, standard error) for each item separately and the mean of all items combined.

In addition to this descriptive information, we are interested in whether women who had a hysterectomy that fell within acceptable guidelines will be more satisfied following surgery than women who had a hysterectomy that did not fall within guidelines. As this is a pilot study, we do not have specific predictions about the proportion of women who will fall into each of these groups, or the likely satisfaction across these groups. However, based on the aforementioned chart review, women will be categorized into two groups (acceptable, unacceptable) and their satisfaction ratings will be compared. Presuming the aggregate satisfaction variable is normally distributed and the within-group variances are equal, a Student’s t-test will be performed. If either of these assumptions is sufficiently violated a Wilcoxon two-sample (Mann-Whitney U) test will be carried out instead. We expect the t-test to indicate that women in the “acceptable guidelines” group will be more satisfied with their surgery than women in the “unacceptable guidelines” group.

• Sample Size and Power Analysis

The estimate of the sample size needed or the estimate of the power given a limited sample size should be driven by the primary objective of the research study.  The sample size should be large enough to have sufficient power to detect the minimum difference in the primary outcome variable(s) that is viewed to be clinically significant.  Reasons for picking this minimum difference should be provided.  The sample size should also be large enough to take into account dropouts if appropriate.  If the estimated sample size is unattainable due to various factors (limited recruitment time, limited number of patients, etc.), you may only have sufficient power to detect very large differences.  In these cases, a power calculation should still be performed and you should state the difference you will have sufficient power (>80%) to detect.  The power you will have to detect the minimum difference viewed to be clinically important (worth detecting) should also be stated.

The method used to determine the appropriate sample size depends on what type of analysis will be used for the primary outcome variable or hypothesis.  If there are more than one primary outcome variables or hypotheses, sample size calculations should be done for each one and the largest sample size selected.  The following are some examples and sample wording for various situations.

Example 1:
Primary objective is to estimate the prevalence of cesarean sections

Our primary objective is to estimate the prevalence of cesarean sections.  We anticipate 10% of births to be cesarean sections (cite source, i.e. preliminary study, historical value).  In order to achieve 95% confidence intervals of +/- 3% we need to include 500 women in our sample.  With a sample size of 500 there is a 95% probability that the estimate obtained will be within 3% of the population value.

Source: Fleiss, Statistical Methods for Rates and Proportions

Example 2:
Primary objective is to compare smoking cessation rates between two groups

Our primary objective is to compare smoking cessation rates between group A and group B.  Group A is expected to have a 20% cessation rate (cite source, i.e. preliminary study, historical value).  A 15% difference in cessation rates between the two groups is viewed to be clinically significant (provide reasons).  Randomizing 140 subjects to each group will give us >80% power to detect a 15% difference in cessation rates (p1=0.20, p2=0.35, two-tailed test, type I error rate=0.05).  With an expected 10% dropout rate we will need to recruit 156 subjects per group for a total sample size of 312.

Source: Power Analysis and Sample Size software, version 6.0

Example 3:
Primary objective is to compare average weights between two groups

Our primary objective is to compare the average weight between group A and group B.  Group A is expected to have an average weight of 150 pounds.  Previous studies have shown the standard deviation of weight to be 12 pounds.  We would like to have 90% power to detect an average weight difference of 10 pounds.  Using a two-sample t-test with a two-sided significance level of 0.05, we need 32 subjects in each group to have 90% power to detect this difference (x1=150, x2=160, standard deviation=12).

Source:  nQuery Advisor software, version 3.0

Limitations of this research

Describe the limitation of the proposed approach and analysis.  This may be especially true when collaborating with external researchers.

Investigators

• Describe the roles and responsibilities on this project of each member of the investigative staff (PI, co-investigators, and statistician). If the overall PI is not at HealthPartners, describe the role of the HealthPartners’ PI in the project.  Provide assurances that the HealthPartners’ PI is qualified to lead this project.

Environment

Explain what efforts have been made to minimize disruption and overuse of HealthPartners’ resources, personnel, or members/patients and why the proposed environment is the appropriate for the proposed study.  Include any efforts to establish collaborative working relationships with other entities, consortium contractual arrangements, and/or organizational structures that are being constructed, including appropriate funding responsibilities of all aspects.  Attach any flow charts as Appendices.

Resources and Expenses

• Describe all of the resources (i.e., clinics, charts, labs, equipment) needed to implement the project and the agreements you have with departments, clinics and managers to access these resources.
• Attach letters of support from other departments from all leaders accountable (financial and clinical) for any HealthPartners area affected by the study should be included. These signatures help assure the reviewers of your project that those who may be impacted by your work are aware of your plans.

Post Project Treatment Commitments

Acknowledge that the treatment strategy (drug or service treatments) proposed in the application does not commit HealthPartners to covering or continuing to provide the treatment or program support after the study is completed.  If this study is a drug study, state whether or not the drug is FDA approved and currently listed on the HealthPartners’ formulary.

Other Review

Explain whether or not this proposal has been submitted for other review and/or received approval/rejection in another review, including, but not limited to: Federal, collaborative agency, previous HealthPartners’ (rejected), or other funding sources (e.g. nonprofit foundation review).  Provide dates of submission and status of review (approved, pending, or rejected).

References

Attach literature citations that support this project.

Part C, Human Subjects Protections

Research Training

All researchers and staff at HealthPartners (any entity) who have direct involvement in proposing, performing, or reporting research are required to complete a training course.  Their ability to work on this research project is contingent upon completing this training requirement.  If anyone has taken this training elsewhere, please submit any certificates of completion for our records.

It is recommended that you complete Part A and Part B before you answer the questions in Part C.  If you have questions about Part C, please contact the IRB office at 651-254-3391.

Certifications & Assurances

Signatures:
The Principal Investigator MUST sign the application. The PI must also forward a copy to the head of their department.

Submission Information

Submission questions? Call 651-254-2928 for more information.

If you have any questions about how to complete these sections call the Office of Research Subjects at 651-254-3391 for assistance.

• Clinical Research
• Health Services Research
• Exempt Research
• Animal Studies