Managing Human Subjects Research Projects: A Tool Kit for Project Managers
5. Preparing for Data Collection
The role of the project manager may vary in the early phases of data collection depending on several factors, including the scope of work, the investigator's knowledge and familiarity with the research process, and the structure of the research institution. Because project managers often serve as collaborators on some or all of the design and budget phases, helpful strategies for the preparation of research and communication with investigators are outlined in this section.
5.1 Establishing the Study Design, Timeline and Budget
Typically, investigators have ideas about the type of study they would like to conduct initiate most research projects. The role of the project manager in the study design phase may be limited, but often investigators work closely with project managers to adjust the design, timeline and budget as financial support is allocated. In any case, it is useful for the project manager to prepare complete budget estimates for the study and to review budgets with investigators at the beginning of the study and periodically throughout the project. Many project managers specify the project timeline and budget in a formal proposal letter that is reviewed and signed by investigators.
Research budgets and timelines often are influenced by many factors in the study design - primarily by the interview mode (e.g., telephone or in-person), questionnaire length, and sample size. Project timelines often are useful for keeping track of projected goals for both the entire grant period and each fiscal grant year. Important milestones should be noted in the timeline for future reference. Periodic reviews of the timeline should be included as a standard procedure for all research projects.
5.2 Designing the Study Questionnaire and Qualitative Data Guides
The instrument design process will vary depending on the type of study, the length of the questionnaire and the number of questionnaire revisions. In particular, there are three main survey modes: mail (self-administered), in-person interviews, and telephone interviews. Data from both self-administered questionnaires and those administered by an interviewer can be collected using a paper and pencil method or computer assisted method. The questionnaire types and instrument design will vary depending on the mode of administration and data collection. Common procedures used for the development of various types of data collection instruments are outlined in this section.
Creating a Measures Binder for Quantitative Survey Instruments
As questionnaires are developed, the project manager can assist the PI by developing a Measures Binder. A Measures Binder is useful to document each scale and individual item considered for use in the study. The project manager can help track in-house and existing scales and items by collecting hard copies to include in the binder, labeled with the author's name and citations for validation studies. This documentation will be helpful to investigators as they begin to develop publications and need to describe the scoring and psychometric properties of each scale and individual item.
The project manager may also help to obtain approval from researchers to use the existing, published scales and/or individual items, and document the permissions in the Measures Binder. A hard copy and an electronic copy of permissions and relevant scales and items should be kept on file.
Upon selecting a final survey instrument, the project manager may develop a data codebook consisting of all study variables and values along with a description of each variable. The final survey instrument and associated codebook should be kept in the Measures Binder, along with labeled and date-stamped copies of all previous versions of the data collection instruments.
Quantitative Data Entry Software Systems
There are many software systems available for data entry and analysis, as well as survey development. Common software programs utilized for programming research questionnaires include:
- Blaise: Blaise is powerful and flexible software available for Windows-based systems. The software is designed to support telephone interviewing, face-to-face interviewing and data entry. The system includes methods and utilities for conditional question routing, using multiple languages, coding, looking up data in external files, data manipulation, weighing data, data documentation and exporting data to external statistical packages or databases.
- CASES: CASES (Computer-Assisted Survey Execution System) is a software package used for computer assisted telephone interviewing (CATI). It is useful for collecting survey data based on structured questionnaires, using telephone or face-to-face interviewing as well as self-administered procedures. It also contains built-in quality assurance and scheduling features.
- Surveycraft: Surveycraft is software that allows researchers to create questionnaires and administer questions in any format (using pen and paper, CATI, CAPI, Web or any combination of these). The software also helps to manage the revision process and is capable of producing questionnaires and analyses in Asian languages such as Chinese, Japanese and Korean. See https://www.ibm.com/analytics/us/en/technology/spss/.
- Access: Access is a data management program useful for data entry and subsequent analysis using various programs such as SAS, SPSS, and EXCEL. It is also useful for the development of spreadsheets. See https://products.office.com/en-US/access.
Qualitative Data Collection
In addition to collecting and analyzing quantitative data, many investigators also collect qualitative data via focus groups and/or key informant interviews. The project manager may play a role in developing the question guide for the facilitator or interviewer to use during focus groups and key informant interviews. Similar to a questionnaire, the guide consists of important questions to ask research participants. The difference between qualitative and quantitative data collection is that, while quantitative data mostly requires concrete answers to questions using a scale, qualitative data provides an in-depth explanation for the concrete answers given during quantitative data collection. Focus groups and key informant interviews are tape recorded and transcribed. Often, project managers summarize the qualitative data analysis using various software programs, including NUDIST (N6), NVivo, and Snap Survey software. These programs allow focus group and interview transcripts to be coded on screen and examined across multiple transcripts. www.qsrinternational.com
SNAP survey software allows researchers to design questionnaires and conduct analysis using two different models. The snap Internet Model provides five different ways of creating questionnaires for publication on internet and/or intranet web sites, as e-mail attachments and plain text e-mails. The PDA interviewer model uses snap professional software using pocket personal computers as interviewing devices. See http://www.snapsurveys.com
5.3 Drafting and Documenting Research Procedures
Data collection process and management are conducted simultaneously. Maintaining quality control is an important management function that is helpful in obtaining reliable and valid study data. As such, it is necessary and useful to develop study procedures for the various forms and manuals that will be used during the data collection process. This will maintain continuity and reliability for future researchers.
- Tracking Forms: Tracking forms are used by recruiters and interviewers to track daily contact with research participants. The interviewer should note the time and date for every encounter, whether in person or by telephone. Click here for examples of tracking forms: Interview Tracking form and Tracking form.
- Data Quality Assurance Forms: After data are collected and entered into a study database, it is necessary to examine for accuracy. Staff should use a standard form for citing corrections that were made in the database, including the instrument name, the question number of the answer that was corrected, and the date the correction was made. Both the person making the correction and the project manager should sign the form indicating responsibility for making the change in the database. Access to the database should be limited.
All research participants must sign consent forms before data collection begins. The grantor's required consent form template should be used and modified according to the project's needs and specifications. To protect the personal information of the research participant in the event that private parties, such as attorneys or representatives of the federal government, would ask for the data information to be released, a request for a Certificate of Confidentiality granted by the National Institutes of Health should be sought and added to the original consent form(s). In some cases, this form is called a Research Subject Authorization Confidentiality and Privacy Rights Form.
5.4 Developing a Study Procedures Manual
Developing standard procedures for implementing various aspects of the study is integral to the scientific rigor, and therefore the validity and reliability, of the research findings. Project managers often are responsible for making sure that all study activities are conducted in a standard way. One way to ensure standardization of study activities is to develop a manual of study procedures for all staff to follow. Examples include protocols for recruitment and consent procedures, interviewer guides, incentive payment procedures, etc. The investigators and research staff members should have access to the study procedures manual at all times.
5.5 Effective Communication and Meeting Facilitation Strategies
Effective communication skills are crucial to successful project management. The project manager is the key person responsible for demonstrating effective communication. Effective communication skills incorporate the following strategies:
- Paying attention/active listening
- Comprehension/review of expectations.
Clear and detailed expectations should be communicated to project staff with respect to the project timeline and goals that should be reached within the specified time. To ensure that all team members have an adequate understanding of roles/expectations: 1) communicate them effectively and consistently; 2) review guidelines/expectations as needed; and 3) provide written documentation of expectations with verbal follow up (or vice-versa).
One of the most challenging elements of effective communication is choosing the best method of communication (email, phone, in-person). Academic research environments often rely heavily on email as a form of communication. Although email is convenient, it does not allow you to understand the extent to which the involved staff member(s) have read and/or understood the communication. The preferred method of communication, especially for important guidelines and/or expectations, is verbal communication (telephone or in-person meetings) with written follow-up (meeting minutes or email). This way, all parties involved may engage in a dynamic conversation about expectations and duties, allowing for conversational nuances and details to be more clearly communicated.
Tips for Facilitating Research Meetings
An essential element of managing complex projects is effective communication throughout the entire implementation of the project. This would involve all members of the project, including field surveyors or interviewers, project coordinators, data managers, research assistants, project advisors, co-investigators, principal investigators, and funding agents. All study personnel must be held accountable for effective processing and dissemination of information. A primary mechanism for the distribution and dissemination of information is the staff meeting. A meeting is an indispensable venue for presenting and distributing information and, if used effectively, can be a strategic tool for productive decision-making.
Some basic elements of a productive meeting include the following:
- Meeting objective(s)
- Meeting facilitator
- Meeting participants
- Active participation
- Time management
- Meeting minutes
What is the reason for the meeting and what should the meeting accomplish? Some of the primary reasons for meetings are to 1) share information, 2) make decisions, and 3) accomplish tasks. Establishing meeting objectives sets the tone and format for the meeting. Meeting objectives should be clear.
Who should attend the meeting and what are their roles and expectations? Inviting the right attendees to the meeting is essential. Meeting attendees should be able to offer input on the meeting objectives. (For example, requesting the presence of a data manager at a recruitment strategy meeting would probably be unproductive because he or she is not directly involved with the recruitment process; however, requesting the attendance of a community advisor would be useful because such a person would have a clear understanding about community nuances that can make or break study recruitment efforts.)
Who conducts the meeting? Typically, the project manager and/or study PI facilitate team meetings because they are directly responsible for making sure that all study procedures are being implemented correctly. The facilitator should ensure that all items on the agenda are covered sufficiently within the allotted time for the meeting.
What items will be discussed during the meeting? The agenda should tie into the overall objectives of the meeting. Each item listed on the agenda should be able to be openly addressed during the designated timeframe of the meeting. Prior circulation of the agenda is extremely helpful.
How can the facilitator maximize attendees' input? The meeting facilitator should make sure all attendees have adequate opportunities to speak during the meeting. It is important to establish up front that everyone's input is not only valued and respected, but also essential to the successful implementation of the project or study.
How long will the meeting last? It is very important to be considerate of meeting participants' time. Having the meeting start and end on time shows consideration to those participating. If the meeting is stated to last 1 hour, try to keep the meeting on schedule. If it appears that discussion on particular topics is running over, the meeting facilitator may consider postponing additional discussion until the next meeting.
How should meeting items and resolutions be formally documented? All meetings should be documented through meeting minutes that are disseminated to all meeting attendees. Meeting minutes should include a list of attendees, agenda items and their resolution and/or action. Incorporating an "Action Item" list in the meeting minutes is useful to ensure timely follow up. Generally, meeting minutes should be reviewed and approved during the next scheduled meeting. This process shows that all meeting attendees are in agreement as to the items discussed during the previous meeting.
A productive meeting can have different formats, such as face-to-face, conference call, or web conferencing. The format or combination of formats chosen for your grant meetings will depend primarily upon attendee geography and available funding and resources, including meeting space and information technology.
The benefits of a traditional face-to-face meeting are that all attendees are in the same location, which allows for multi-faceted communication, including body language. The use of body language in a meeting, either conscious or subconscious, can effectively stimulate additional input and discussion and possibly minimize miscommunication.
Conference calls allow people from various locations to participate in the meeting without traveling. A conference call can be extremely convenient, as people can interact individually or as a group from their home or office. Conference calls organized through central conferencing centers offer the added advantage of meeting recordings, which can help tremendously when taking meeting minutes.
Web conferencing is a relatively new meeting format where participants log in to a specified location on the World Wide Web. It can serve as a forum to present data or reports and generate discussion in real-time to online meeting attendees. Web conferencing can be a true complement to face-to-face or conference call meetings by allowing presenters at different locations to communicate with a live audience and share immediate feedback.
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