Study Planning: Feasibility Assessment

Committing to a new study without first determining that it is feasible can create a Conflict of Commitment. The principal investigator must ensure that they have the time, staff, funding and other resources to successfully complete the project. Otherwise, there is a high likelihood that the study will not be completed and subjects will been subjected to risk of harm for no benefit.

Considerations for Planning and Agreeing to Conduct Human Subjects Research

• Time: Does the investigator have adequate time to devote to study oversight and the work that he/she must perform? If not, then no new studies should not be started until there is. See Delegation of Responsibility.

• Other Obligations: Are there anticipated personal, financial, or professional obligations for the investigator or the study staff that might interfere with meeting the study commitments? New studies should not jeopardize ongoing research projects, nor should they delay a trainee's progress on their research.

• Funding: Is there adequate funding (budget appropriate), sufficient personnel and space for study procedures available to conduct the study?

• Study Procedures: Does the investigative team have the ability and hospital credentials needed to perform all required study procedures?

• Are facilities and equipment adequate to perform the study?

• Contract Terms: (When there is a sponsor) Does the investigator and/or administration agree with the terms of the contract set forth by the sponsor?

• Available Subject Population: Will there be enough prospective participants available and are there reasonable expectations that enough will agree to participate and complete the study during the time frame planned for the study?

If the answer to any of these questions is No, then a plan is needed to overcome the deficiency or the study should be postponed (or abandoned).