Guidance Library & FAQ

Guidance Library

Manuals & Guidance

Review Types & Decision Charts / Worksheets

Conduct & Research Activities

Special Populations

Collaborative / Multi-site Research

HIPPA

Quality Improvement/Quality Assurance/Program Evaluation

Frequently Asked Questions

Collaborative/Multi-Site Research

Campbell University researchers may engage in collaborative research with individuals and organizations outside of Campbell University. Often circumstances require agreements between collaborators to be in place prior to conducting research activities with human subjects.

Examples of  research agreements include:

  • Institutional Authorization Agreement (IAA)
  • Individual Investigator Agreement (IIA)
  • Letters of Support
  • Other Collaborations such as Data Use Agreements

Please see  IRB Guidance: Collaborative Research for detailed information on each type of agreement.

If you have any questions, please contact the IRB Office.

If you human subjects research is funded or sponsored, the IRB Office must ensure the research activities described in the grant/funding proposal are consistent with the information in your protocol submission. In order to avoid delays in award set-up and access to funds, it is imperative that awards administered by the Office of Research & Sponsored Programs (ORSP) be formally associated with an approved human subjects protocol.

  • To associate funding during the initial review of the protocol, submit Funding and Sponsorship Form and the human subjects portion of the grant proposal with the initial review materials.
  • To associate funding with an existing protocol, submit a Funding and Sponsorship Form and the human subjects portion of the grant proposal along with the Amendment Submission Form materials. If the addition of funding alters previously approved human subjects research activities, the amendment submission must include revised protocol information and materials, as applicable. Any proposed changes to previously approved research must be reviewed and approved prior to conducting the research activities and before the award can be released.
  • If participant involvement in your sponsored research is yet to be defined, please contact the IRB Office for specific instructions.

If you have questions, please contact the IRB Office.

Research Records

Research records must be maintained for at least three years after completion of the research and must be accessible for inspection or audit. Other regulation or requirements may apply to the retention of records, for a longer period of time, such as HIPAA or project sponsor requirements.

Documentation of IRB approval documents, the approved Research Plan, informed consent documents (without a link to data), and all source materials related to the conduct of the research should be maintained unless the IRB has waived the requirement for informed consent or the requirement of documentation of informed consent.

If you have any questions, please contact the IRB Office.

HIPAA and Human Subjects Research

If research will involve the use of Protected Health Information (PHI), criteria under the Health Insurance Portability and Accountability Act (HIPAA) may apply and the researcher will need to address how their research meets HIPAA requirements in the research submission.

Resources providing detailed information regarding the use of HIPAA information for research see:

Resources providing detailed information regarding the use of HIPAA information for research see:

For more information please contact the IRB Office.