Social/Behavioral Research: Module 8

Research without foreign collaborators

Home institution reviews it Need for local review is determined by policies and regulations outside of US law

Local research context

Socioeconomic context Political context Cultural context Questions innocuous to US context could be offensive elsewhere Authority structures differ -- would people feel compelled to be research subjects? Community leaders and stakeholders may provide important insights of customs, norms, and laws IRBs need sufficient information to meaningfully evaluate research - consultants are allowed

Applicable regulations and guidelines

Federal regulations for protecting research with human subjects + OHRP guidelines are specific National Institute for Allergy and Infections Disease (NIAID) created online database OHRP created list of +1,000 international standards for social and behavioral research Local contacts may be best resources

Securing Local approval

Even if for exempt research, local approval or national approval may be required

A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?

A great deal of research in the social and behavioral sciences may qualify for exemption, depending upon institutional policy. If a proposed study qualifies for exemption, federal regulations DO NOT require review at the foreign site where it will be conducted. Federal regulations do not require exempt research to be reviewed by an institution's IRB or an institutional official - those decisions are left to institutional policy.

Foreign standards governing research

Canadian Tri-Council Policy Statement Indian Council of Medical Research (ICMR) Council for International Organizations of Medical Sciences' (CIOMS) 'International ethical guidelines for biomedical research involving humans" World Medical Association of Declaration of Helsinki

Additional resources

ClinRegs.gov OHRP "International Compilation of Human Research Standards." (https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html) "Listing of social-behavioral research standards" (https://www.hhs.gov/ohrp/international/social-behavioral-research-standards/index.html)

Exempt research

Does not require review at foreign site where research will be conducted

What does NOT fall under engagement?

Informing prospective subjects about research Providing written information about research (may include informed consent document and other IRB-approved materials) but do not obtain consent or act as representative of investigators Provide information about contacting investigators for enrollment or more info Obtain and document prospective subjects' permission for instigators to contact them Provides a space of US researchers to conduct their own research

"Engagement"

It means the institution is recruiting and securing consent from subjects, conducing research procedures, receiving or sharing private, identifiable information

A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB?

There are several factors that determine what kinds of review are needed for international research, including if the researchers have collaborators at the research site abroad. If international research is carried out without the involvement of FOREIGN COLLABORATORS the research may be reviewed by the researcher's home institution. The need for local review will be determined by policies and regulations rather than by U.S. law. When U.S. researchers collaborate with researchers at foreign institutions, determining the appropriate review type and method depends on whether the collaborating institution is engaged in the research. The other responses are incorrect because they do not help the IRB determine where the research should be reviewed.

Things to consider when getting informed consent

What other individuals or groups whose permission must be sought AFTER getting consent of individual? (like spouse or head of household) Appropriate language for consent (formal vs local language) Oral or written? Can they read? Can their culture tolerate written documentation of consent? Interpreters -- possibilities of undue pressure or influence, selection bias, clear and unbiased translations Age of majority in that country? Local norms should be reflected in parental permission and child assent processes Is there a local contact person?

Determining where research should be reviewed

Will the researcher have collaborators at the research site abroad? What is the role of the collaborators? Will they be engaged in the research? IS it federally funded? If yes, by what department or agency?

Research with foreign collaborators

Must determine if the foreign institution is "engaged" with research Must determine if it's federally funded, and if so, by which agency. That federal agency needs to have written assurances from collaborating institutions about how they will protect research subjects Common rule 2018 does NOT require assurances to include the principles of that institution to be included