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

1. Staffing Research Projects

In order to successfully implement a research study, it is imperative to hire staff capable of achieving the desired outcomes. The following sections will address staffing issues, including hiring and training staff and building good staff relationships.

1.1 Hiring Staff

When starting a project, it is important to define the project's staffing needs. The project manager must translate the project's goals into tasks and positions needed to complete the tasks. This entails thinking about the process of determining what is necessary to meet the goals of the project (e.g., recruitment, interviews, data entry, etc.). It is important to think about key qualities and strengths that are crucial to the effectiveness of the project. The project manager needs to ensure that the number of employees matches the estimated workload while remaining within the budgetary limits for hiring staff.

In order to adequately staff the project, it is necessary to write detailed job descriptions for each specific role in the study. Job descriptions should be clear and concise so that expectations are comprehensible. The job description should include, but not be limited to, the following:

  • Position overview
  • Position requirements
  • Position responsibilities
  • Performance expectations
  • Physical and mental demands
  • Work schedule
  • Salary and benefits
  • Supervision

Once the job descriptions are written, they should be posted with the institution's human resources office, on the Web and/or in local newspapers. When potential candidates have been identified, the project manager must interview them to ensure that the most appropriate candidate is hired. It is also essential to consider how different qualities and personalities will work within the research team. The team should be balanced so that each individual brings a key quality or qualities to the group.

When conducting position interviews, it is advisable to prepare a comfortable environment to put the interviewee at ease. Begin by providing a brief explanation of the general details of the research project. Questions should be prepared in advance and should be open-ended so that the interviewee does most of the talking. Probe the resume to clarify any unclear points, and conclude the interview by giving the interviewee the opportunity to ask questions.

1.2 Orienting and Training Staff

Orientation is the process for welcoming new employees and providing general administrative information about the institution. New employee orientation is, for the most part, conducted by the institution's human resources office and generally contains information about the work environment, safety, benefits and benefit eligibility criteria. A separate orientation to the center or department should include the following:

  • History, mission and goals of the larger institution
  • History, mission and goals of the Center/department
  • Current Center/department status
  • Daily operations of the Center/department (e.g., staff meetings, work hours, lunch hours, leaves of absence, etc.)
  • Trainings
    • Human subjects training
    • Adverse event reporting
    • Roles and responsibilities
  • Performance planning and evaluation process
  • Institution policies and procedures
  • Introduction to staff, their responsibilities and chain of command
  • Workplace tour (restroom and kitchen facilities, cafeteria, etc.)

It is important to establish a clear chain of command so that new employees know who the project managers are. An ideal new employee orientation:

  • Has targeted goals and meets them.
  • Makes new hires productive on the first day.
  • Is not boring, rushed or ineffective.
  • Makes the new employee feel a part of the team (may use ice breakers and/or have a lunch outing).
  • Uses feedback to improve subsequent orientations.

1.3 Supervising Staff

Components pertinent to effective supervision are described below.

Clearly Define Expectations

The key to effective supervision is clear and reasonable expectations. In order to achieve a desired task related to the research study (e.g., five interviews per week, complete delivery of the intervention as instructed, etc.), the staff member needs to know what the goal is and how best to achieve it.

Expectations should be outlined in writing so that there is no question about the details of particular tasks and outcomes. Expectations should be clear and specific and can pertain to any or all of the following:

  • Hours
  • Quality of work
  • Completeness of work
  • Timeliness of work
  • Appropriate dress
  • Level of professionalism and conduct
  • On-going training

Once expectations are known, the PI, project manager, and employee must all be accountable for those expectations. If a staff member is not meeting expectations necessary to achieve the project goals, it may be that he/she is unable to meet the expectations. To correct this, additional training or extra encouragement may be needed to raise his/her level of proficiency. Not meeting expectations may also suggest that a staff member is unwilling to do so, which may require either exercises to increase motivation or reassignment. Probation and/or termination should be explored if the previous options are not possible or do not produce the desired result.

Communication

Communication is critical to effective supervision. It must work in both directions (i.e., from project manager to staff member and from staff member to project manager). Honest communication requires good listening skills (which may need to be taught and/or reviewed) and a supportive, non-judgmental environment in which each party feels comfortable sharing his/her feelings without concern for negative consequences.

Several factors contribute significantly to effective communication, including, but not limited to:

  • Availability: All parties should have adequate availability in order to facilitate effective two-way communication. Availability will be determined by the nature of the work to be performed and other responsibilities. It is helpful to know the best days and times to reach one another, and times when one person may be unavailable for contact (e.g., vacation, professional leave, family leave, etc.). If a project manager will be unavailable, it is imperative that an alternate contact be identified in the event that there is an urgent matter.


  • Responsiveness: Prompt response enhances effective communication; expectations for response times should be established at the start of employment. Responsiveness applies to phone and email as well as in-person contact.

Conflict Resolution

Conflict situations are those in which the concerns of two or more people do not seem to be compatible. In research project settings, conflict is almost inevitable, but does not have to be negative if managed properly. Project managers should establish a creativeand innovative environment that encourages the completion of the project goals, despite staff conflicts.

Aspects to consider when there is conflict in the workplace include:

  • Detecting conflict: The first step is to acknowledge the conflict and take responsibility for dealing with it in a comprehensive and open way.


  • Creating a communication plan: Project managers should create a work environment that is conducive to openly communicating about and resolving conflicts. Staff members should know the appropriate channels through which to communicate about conflicts and feel comfortable expressing concerns directly with other staff members and the project manager.


  • Understanding cultural differences: When there are projects that include employees from diverse backgrounds, especially projects that involve employees from different racial and ethnic groups, project managers should have a strong understanding and sensibility about the values, beliefs, and practices of the different cultures represented in the Center.

Follow-up

Without follow-up, expectations and communication have little value, and involved parties may lose interest and sight of the goal. Follow-up can occur in several forms, including individual or group meetings. Depending on the study environment, follow-up may occur in-person or via conference calls or email. Follow-up arrangements can be established by the project manager and/or by the staff members, depending on the purpose, need and urgency. For more consistent contact, progress reports on tasks completed during the week and tasks scheduled for the following week can be submitted to project managers for review. This may be especially helpful if staff members have a heavy workload or if project managers manage multiple staff on multiple projects. Weekly staff meetings are also an effective strategy for follow-up.

If field work (i.e., interviews, intervention delivery) is a task for staff members, observation of those staff members conducting interviews or delivering intervention components should be conducted by a project manager at intervals appropriate for the project. This contributes to process evaluation and, in turn, enables the project manager to give specific, timely feedback to the staff member regarding accuracy and quality.

It is important that regular follow-up be established early in the supervisory process so that it becomes an integral part of the relationship. Feedback to staff members should be prompt and specific so that changes can be made immediately, if necessary. Once specific feedback is given to the individual, it may benefit other staff members to hear the same message.

Opportunities for staff members to provide feedback to project managers is also recommended so that project managers may best meet the needs of their staff members.

Long-distance Supervision

It can be challenging to supervise staff members who are not always in the office. It is necessary to have an organized opportunity for communication among staff, with clear expectations and a regular schedule of follow-up and feedback. Some aspects to consider when dealing with long-distance supervision are establishing and conveying a clear understanding of the project's priorities and the responsibilities and deadlines of each staff member.

1.4 Delegating Responsibilities

One of the primary tasks of a manager is to delegate responsibilities and tasks to achieve the project goals. It is important to have a clear idea of those tasks and relevant timelines for completion before delegation begins.

Maximize Efficiency

  • Evaluate potential candidates on the basis of their strengths and weaknesses in relation to what tasks they will be hired to perform (interview/pre-hire phase).


  • Know the strengths and limitations of staff members and delegate considering those strengths and limitations.


  • Know what tasks staff enjoy doing to achieve higher quality work and willingness to volunteer for future opportunities.


  • Avoid delegating only those tasks you do not like to do or are not willing to do. Perceived fairness and balance from the perspective of the staff member may help minimize staff turn-over and may contribute positively to staff morale and the ultimate success of the project.


  • Know when to stop delegating. Overloading staff members, especially those with a strong sense of responsibility, may lead to job dissatisfaction, burn-out and a higher rate of staff turn-over.

1.5 Increasing Staff Motivation

Staff motivation is an important staffing issue, and it is helpful to know what specifically motivates individual staff members at the beginning of the supervisory process.

  • Feedback: Feedback of any kind is helpful to increase staff motivation; however, positive feedback is more readily accepted than negative feedback. Feedback can come from either project managers or research participants. Positive feedback from research participants is especially helpful at annual reviews. Feedback can be written or verbal.


  • Recognition: Staff may be motivated by public or private recognition of their efforts, depending on their preferences and personalities. Recognition can be written or verbal.


  • Gift incentives: Staff may be motivated by monetary or gift incentives either for achieving a specific milestone (e.g., 100 interviews) or for going above and beyond basic position requirements.


  • Small words of encouragement: Small words of encouragement, either in-person, over the telephone or at the end of an email, can go a long way to let staff members know they are valued and appreciated.

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