Human Research Protection Program (HRPP)

Protecting the rights and welfare of human research participants

The role of the Human Research Protection Program (HRPP) is to protect the rights and welfare of research participants through an organization-wide review, education, surveillance and engagement process. In order to maintain a viable and continuous HRPP, everyone within the organization must be involved in and supportive of this program. All employees, investigators, vendors, and partners of the organization are taking responsibility for the ethical, humane, lawful and professional treatment of human research participants, and for the proper safeguarding of their data.

The benefits of an HRPP include:

Do you want to learn more about how our HRPP can benefit your clinical study?

By selecting a biotech CRO possessing its own comprehensive HRPP to manage your clinical study, the advantages of HRPP oversight will translate to your research program and greatly improve your research participants’ experience in your clinical trial.

Since its inception in 2002, ethica has been dedicated to ensuring that its processes respect participants’ rights and that its services are delivered according to the highest standards of ethical and clinical practice.

Our Accredited Human Research Protection Program

HRPP accreditation by an independent industry-recognized organization confirms that an organization’s processes ensure the respect and protection of research participants, and that their services meet or exceed the industry’s standards.

ethica CRO’s HRPP received accreditation by the following accrediting bodies:

For more information on ethica CRO’s accreditation history and procedures, please visit our Accreditation page

Our HRPP Approach

At ethica CRO, we pride ourselves in delivering services that meet the highest standards of ethical and clinical practice. Above all, we are committed to treating our research participants with respect and protecting their rights and welfare throughout the study process.

Our HRPP’s Role and Responsibilities

Beyond safeguarding the rights and welfare of human research participants, ethica CRO’s Human Research Protection Program also has the responsibility of educating investigators, sponsors, research staff, IRB members, and research participants on the ethical durability of all research activities.

The HRPP will ensure that investigators and research staff are properly trained to perform study procedures and have no conflicts of interest which could adversely impact participant care or bias the study. Participants will be given all the necessary information and time to make a free and informed decision about participating in the study.

The HRPP will also implement a comprehensive unanticipated problem reporting and management system in your research program to assure that the conduct of study activities complies to all applicable local, provincial, and federal laws and regulations and continuously respects participants’ rights.

Another important responsibility of the HRPP is to oversee the internal monitoring and auditing of research activities throughout the study’s lifecycle to ensure that any new information applicable to the study protocol is clearly communicated to research participants and yields the appropriate adjustments throughout the study process.

Near the end of the study process, the HRPP will assure that final data is free from bias and adequately analyzed to ensure honest reporting of the study’s results to the scientific community and all research participants.