As international research continues to grow, the CPHS has recognized the need for guidelines in the submission and review of protocols in which the setting or research are to be used in other countries.

In this context we are presented with challenges to maintain our ethical, conduct and care standards while in countries and cultures different from our own. It is incumbent upon UT-Houston investigators to be sensitive to local cultures and practices, yet adhere to the same high standards of research ethics wherever investigations occur. It is the aim of these guidelines to be respectful of the countries we will enter and to anticipate any challenges that differences might represent.

We ask that you pay particular attention to this set of guidelines as you develop your protocol for review by this Committee.

Relationships with community of interest:

Often UT-Houston investigators embark on research efforts in a collaboration or relationship with an institution, a medical school, clinic, or governmental health agency in the foreign community of interest.

The submitted protocols should include permission or approval from such collaborating agencies that outline the roles and responsibilities of the institutions involved. It is understood, however, that these may not be in place at the time of submission to the CPHS, but they must be in place before final approval can be granted.

The collaborating institution and on site investigator of necessity must be relied upon to assist the UT investigator and CPHS in understanding the cultural and ethical context in which the proposed research is to be conducted.

The protocol submitted to the CPHS must take into account the following:

Collaborators and institutional policies

The protocol should include the following when applicable:

1. Names and titles of collaborators on site;
2. Presence of an ethical review committee within the country/institution/site where you intend to carry out the research that will review the research project;
3. Ethical principles on which the local groups base their decisions (differences and similarities with U.S. principles);
4. Listing of the membership of the ethical review committee with some description of members’ credentials;
5. A letter of approval from the ethical review committee;
6. Demonstration of approval of Ministry of Health when applicable.

Language

The protocol should include the following when applicable:

1. The primary language of subjects, co-workers, government/local officials;
2. Names of those on the team who are fluent in this language;
3. Arrangements for translation of the informed consent form and for translators at the site.

The CPHS recognizes that each project and community is unique. Make every effort to describe the challenges that different languages will represent for you as a UT investigator, and the plans to overcome language barriers.

Cultural Attitudes

The protocol should include the following when applicable:

1. Integrity of individual consent to participate (for example, the role tribal/village leaders have regarding consent, or the role of husbands in granting consent for household members);
2. Practices regarding informed consent by women and assent by children;
3. Conflicting values and beliefs within the study area that will impact the conduct of the research (for example, tensions between political, religious or racial groups that may place some subjects in vulnerable situations).

The CPHS expects investigators to be sensitive to and respectful of the cultures and attitudes of the community of interest. However, the UT investigator must maintain the ethical and care standards of his/ her profession and institution.

This may pose difficulties in conducting research when cultures and standards are different. Every effort must be made to find areas of shared values and beliefs (i.e. voluntary informed choice to participate in research) so that no one is asked to compromise his/her values.

The protocol should describe the possible challenges posed by the identified cultural and ethical differences and your plans handle these challenges.

Clinical care and research standards

Demonstrate or describe when applicable:

1. Appropriateness of the intervention to the community (stated health needs and priorities of the community, for example);
2. Availability of medical care (independent of the research) to the persons in the community where research will occur;
3. Arrangements for medical emergencies;
   Training of the local research team in protocol requirements and technologies.

Closing the study

Include, when applicable:

1. Provisions for dissemination of results within the country where the research takes place;
2. Provisions for care after the study (particularly important when the subjects are at high risk for the disease under study);
3. Permission(s) required to remove specimens/samples and data from the country;
4. Regulations regarding ownership of data generated from the study;
5. Authorship agreements;
6. A statement in all publications that the project was reviewed by the UTHHSC Committee for the Protection of Human Subjects.