Part V - Distribution of Responsibility | KCTCS

Part V

Distribution of Responsibility

The responsibility for the protection of subjects in research is distributed among several parties: the responsible project investigator, the KCTCS District Chief Executive Officer, the Human Subjects Review Board (HSRB), and those at cooperating institutions who provide access to subjects.

Responsible Project Investigator

The individual responsible for the conduct of the activity, i.e., the responsible project investigator, has primary responsibility for the protection of the rights and welfare of human subjects. Specifically, the investigator is responsible for:

  • Carefully designing research methods,
  • Adhering to ethical codes and applicable policies and procedures of the KCTCS, the sponsoring agency, and cooperating institutions, if any,
  • Training and supervising personnel carrying out the research, both with respect to appropriate research methods and the rights of human subjects,
  • Obtaining prior (i.e., before any involvement of human subjects) approval for non- exempt human subjects research,
  • Obtaining prior approval for changes in a nonexempt research activity,
  • Consulting with the HSRB Executive Secretary to determine if research can be exempt from full review,
  • Reporting promptly to the HSRB any unanticipated problems involving risks to subjects or others,
  • Retaining required records.

KCTCS District Chief Executive Officer

The KCTCS District Chief Executive Officer is responsible for:

  • Ensuring that faculty, staff, and students are kept informed of the KCTCS policy and procedures and of their responsibilities for protecting the rights and welfare of human subjects involved in research,
  • Ensuring that the District review process, if any, operates within HSRB- approved guidelines,
  • Ensuring that, for any course offered by the department in which students are expected to serve as human subjects, notification to this effect is given in the course description in the official college and/or KCTCS bulletins and timetables,
  • Reporting promptly to the KCTCS HSRB any unanticipated problems involving risks to subjects or others.

Human Subjects Review Board 

See 1.8.2.3.2 KCTCS Human Subjects Research Policy.

The KCTCS HSRB is responsible for:

  • Providing initial and continuing review of nonexempt research,
  • Ascertaining acceptability of proposed research in terms of KCTCS policies and procedures,
  • Documenting that reviews are conducted according to KCTCS policy,
  • Providing advice and information to investigators engaged in research involving human subjects.

The KCTCS HSRB is additionally responsible for:

  • Developing policy, procedures, information, and instructions regarding human subjects research,
  • Adjudicating differences and reviewing problems arising in research involving human subjects,
  • Ensuring compliance with externally mandated policies and regulations,
  • Reporting to the appropriate institutional officials and, for research governed by HHS regulations, to the Secretary of HHS, any serious or continuing noncompliance by investigators with the requirements and determinations of the HSRB.

Individual or Institution Providing Access to Subjects

If access to research subjects is obtained through cooperating institutions, the authorized official of the cooperating institution must be informed of the research and should satisfy herself or himself that the subjects' rights and welfare will be protected and that institutional commitments to the subjects will not be abridged.

If professional practitioners or service agencies provide access to subjects, the individual providing access should ensure that his or her professional commitments to the clients are not abridged.

If the individual responsible for conduct of the activity is not a KCTCS employee or student, but the KCTCS is the cooperating institution providing access to research subjects, the individual providing access to the subjects is responsible for ensuring that KCTCS policies and procedures, including review requirements, are met.