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Managing Human Subjects Research Projects: A Tool Kit for Project Managers

4. Fielding Research Projects

This section focuses on the day-to-day tasks involved in research project implementation.

4.1 Managing Data Collection

Effective data management is crucial to the validity and reliability of the data collected. Project managers should ensure that all data are collected and entered in a standard format and that the data quality assurance checks are conducted on a regular basis. The following describes techniques that are useful when collecting data using an in-person or telephone interview approach:

Distribution of work to interviewers

The smaller the workload, the better the quality of work performed by project interviewers. This rule applies to assigning the number of homes that the interviewers need to approach or calls they need to make to collect data for the study. Interviewers are more likely to follow a sampling scheme and specific instructions for home-based interviews if a list of homes by blocks is assigned. This is possible when the project manager conducts a pre-visit to the study area to document the specific characteristics of the area and homes and prepares unique instructions for the interviewers. For telephone interviewers, the project manager should assign calls by equally dividing the sample among interviewers.

Ways to avoid "cherry picking" among interviewers
When the interviewer does not apply the sampling procedure and deliberately selects participants that are to his or her liking, they are "cherry picking" participants. This act of selectively choosing whom to interview will eventually skew the data to a preferred outcome, therefore resulting in an unrepresentative sample of the study population. Possible ways to avoid cherry picking are to:

  • Assign the interviewer a previously screened list of homes to approach.
  • Make sure the list of homes is by the block level or equivalent.
  • Keep track of the total number of homes, not to exceed 50 to 100 per assignment.
  • Conduct periodic quality control checks. This can be accomplished by calling or visiting 10 percent of a random sample of the interviews submitted per interviewer and increasing the percentage by 5 for each discrepancy found.
  • For telephone and in-person interviews, the project manager can review hard copies of a random sample of interviews and compare the captured data to those entered into the database.

4.2 Recruiting and Retaining Respondents

While research studies might differ with regard to institutional preferences and target populations from which to recruit, there are certain key aspects to recruitment that apply to all research institutions and populations. Below we have outlined eight key strategies that were written for recruitment of African-Americans to cancer prevention and control studies; however, the basic concepts can be used to recruit individuals from any population and for any type of research study. Project managers should review Section 2 of this document (Involving Community Members in Health Research) for additional information on how community advisors can assist in recruiting research participants.

Adequately characterize the target population
Project managers should fully understand the study's target population.

Involve members of the target population in planning efforts
Members of the target population will have insight into the community or population that is vital to the conduct of the study and to successful recruitment. Not soliciting some input from the community can alienate the community from the research team and hamper research efforts.

Take the message to the target population
Those involved in communicating with target population should clearly define the purpose of the research. Having a full understanding of the research study will afford individuals the opportunity to make an informed decision about participating. If the message or intent of the research is clearly stated to the research population, this may help to alleviate any rumors or negative press about the study.

Give something back to the community
Assure the community that at the end of the study, results will be disseminated to them.

Enhance credibility of study by using a community spokesperson
If possible, recruit community advisors who are recognizable in the community to assist the research team with promotion and recruitment efforts. This individual or group of individuals should be intricately involved with the study from inception to final data collection and analysis. Working with members of the target community will enhance the validity of the research efforts.

Identify and remove barriers to participation
Each community or population group has its own barriers to participating in research. It is important not to make general statements about a population, but rather to assess the specific needs of the target community and address them in a way that is respectful and conducive to effective research. For example, project managers should think about the differential transportation needs of potential participants in rural and urban areas, as well as possible literacy and language barriers in all settings.

Improve staff sensitivity
Respect for individuals and communities should be the primary factor involved in all recruitment activities. Ensure that all study staff have been provided cultural competency training. Training should include a component on the appropriate manner in which to recruit people of various ages, genders, incomes, etc.

Educate the target population about the importance of prevention and early detection
This statement is true for all types of research. It is important to educate the population about the health concern being studied. It is important for the target population to understand how the disease may affect them on a personal level.

In addition to the aforementioned community recruitment strategies, clinic/hospital-based studies have unique recruitment issues. The buy-in of the clinic administrators and other personnel is imperative to the successful recruitment of patients from clinic/hospital settings. Project managers should consider involving key staff members as community advisors.

4.3 Reviewing Data Quality

Managing incoming interviews can become an overwhelming task if a quality check is not performed periodically. Project managers should conduct quality checks on 10% of the incoming data per interviewer and increase the percentage by 5% for each discrepancy encountered. An initial visual check is recommended before deeming the data as acceptable. Currently, electronic data are commonly used among primary data collectors because they facilitate simple queries/analyses to detect discrepancies at any given moment. Hard copy data collection is limited to visual checks and quality control checks via telephone for verification purposes before it is used in simple analyses to detect more detailed discrepancies.

4.4 Collecting Biological Samples

Research studies may involve the collection of biological samples for use in the analysis of specific biomarkers of interest. Examples of commonly used biological samples include blood, saliva, and hair. It is important to establish detailed protocols for the collection and storage of biological samples in the research proposal and to hire and train staff accordingly.

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