Institutional Review Boards 

in the 

U.S.-México Border 

United States-México Border Health Commission

Current Protocols and Practices

December 2010
The mission of the United States-México Border Health Commission

 is to provide international leadership 

to optimize health and quality of life along the 

 United States-México border.

Providing Leadership on Border Health Issues to—

Facilitate Identification, Study, and Research

Be a Catalyst to Raise Awareness

Promote Sustainable Partnerships for Action

Serve as an Information Portal

December 2010
Institutional Review Boards in the 

U.S.-México Border

United States-México Border Health Commission

Current Protocols and Practices
Institutional

Review

Boards
Executive Summary 1

Introduction 3

Background 3

Methodology 6

Results 7

Observations and Recommendations 11

Conclusion 13

References 15

Annexes 16

Credits 16

i

Table of Contents
Healthy Border 2010/2020 Strategic Framework

Health Research on the U.S.-México Border: Promoting a Binational Agenda

Health Disparities and the U.S.-México Border: Challenges and Opportunities

Frontera Saludable 2010 - Reporte de Medio Plazo - Frontera Norte de México

Healthy Border 2010 Midterm Review U.S. Border Area

Border Lives: Health Status in the Unites States-México Border Region

Researching Border Health: A Review of Initiatives to Develop a Border Health Research Agenda, 1995-2009

Other related publications

www.borderhealth.org
EXECUTIVE SUMMARY

This report presents the results of a study conducted to better understand the framework and operation 

of Institutional Review Boards (IRBs) in the United States and México, with particular attention to 

the states along the international border. The study is based on a self-administered survey and in-depth 

interviews with key informants conducted from December 2009 through February 2010. Participants 

in the survey included faculty, researchers, practitioners, and staff working in public and private 

health institutions with an active research program in any of the U.S.-México border states (Texas, 

New Mexico, Arizona, California, Baja California, Sonora, Chihuahua, Coahuila, Nuevo León and 

Tamaulipas). Most of the participants were selected among individuals who had conducted or were 

conducting research projects involving the study of binational or transborder populations. 

The report also summarizes insights offered by U.S. and Mexican researchers regarding the way IRBs 

operate on both sides of the border and their recommendations to address existing gaps and limitations 

of human subjects protection in the region. Based on this information, a comprehensive list of concerns 

and recommendations is presented for the purpose of developing uniform guidelines for a joint IRB in 

the U.S.-México border region.

The study conducted for this report shows an asymmetry in the operation of IRBs in México and the 

United States. Based on the report survey, universities and research centers in México and the United 

States can be grouped in one of the following three categories: a) schools or research centers that have 

a permanent IRB with a well established review protocol; b) schools or research centers using or that 

have used ad hoc IRB protocols; and c) schools or research centers that do not have an IRB. In general, 

the first category was common among schools or research centers conducting studies in the biomedical 

fields while the last two categories dominate among schools or research centers conducting research 

in the social and behavioral sciences. Most universities, community colleges, and research centers in 

the United States have well established IRB protocols that apply to biomedical, social, and behavioral 

studies involving human subjects.

The survey and interviews for this report also indicate a consensus among participants about the need 

to develop common guidelines for IRB operation or the creation of joint or binational IRB protocols 

applicable on both sides of the border. One of the suggested actions includes promoting collaboration 

among academic institutions to discuss procedures and instruments to protect human subjects at 

the binational and transnational level. Other recommendations include the following: 1) creating a 

binational IRB task force with the endorsement and participation of México’s National Council of 

Science and Technology (Consejo Nacional de Ciencia y Tecnología) and the U.S. National Institutes of 

Health (NIH); 2) developing a binational agenda for human subjects protection through consultation 

with researchers, practitioners, managers, policy-makers, and other public health advocates; 3) 

promoting the exchange of experiences between Mexican and U.S. researchers about IRB frameworks 

and their operation and establishing a curriculum to educate and train students and researchers about 

human subjects protection issues. It was suggested that these exchange and educational programs should 

be considered entry points for the development of broader programs to enforce and monitor protection 

of human subjects in binational and transnational projects.

1

INTRODUCTION

This report was produced on behalf of the U.S.-México Border Health Commission (BHC) to better 

understand the challenges and opportunities involved in developing binational protocols and procedures for 

the protection of human subjects in medical, social science, and behavioral research. To best meet this need, 

a study was designed and conducted to understand the frameworks and operation of Institutional Review 

Boards (IRBs) in the United States and México, with particular attention to the border states. 

The study was based on a self-administered survey and in-depth interviews with key informants—faculty, 

researchers, practitioners, and staff working in public and private health institutions with an active research 

program in any of the U.S.-México border states (Texas, New Mexico, Arizona, California, Baja California, 

Sonora, Chihuahua, Coahuila, Nuevo León, and Tamaulipas). Most of the participants were selected among 

individuals who had conducted or were conducting research projects involving the study of binational or 

transborder populations. 

The report summarizes the insights offered by U.S. and Mexican researchers regarding current IRB operations 

and addresses existing gaps and limitations of human subjects protection in the region. The report also 

includes a comprehensive list of observations, concerns, and recommendations presented for the purpose of 

developing uniform guidelines for a joint IRB in the U.S.-México border region. 

BACKGROUND

The need for research guidelines dealing with human subjects emerged following the Nuremberg trials, when 

medical experimentation abuses perpetrated by World War II Nazi doctors came to public attention. These 

publicized abuses, in effect, led to the creation of the Nuremberg Code in 1945, which was the first legal 

attempt to address ethical issues of modern research. However, as biomedical research efforts expanded, the 

international need for a more specific code of ethics became evident and as a result, in 1964 the Declaration 

of Helsinki was approved (World Medical Association, 1964). To this day, the Declaration of Helsinki is an 

essential reference for sound research practices worldwide and has been the source for the development of 

international ethical and scientific regulations, including the International Ethical Guidelines for Biomedical 

Research Involving Human Subjects (Council for International Organizations of Medical Sciences), the 

Guidelines for Good Clinical Practice (International Conference on Harmonisation [ICH] and World Health 

Organization [WHO]), and the Operational Guidelines for Ethics Committees that Review Biomedical 

Research (WHO) among others (WHO, 2000).

Currently, a variety of terms are commonly used to refer to bodies and procedures when reviewing ethical 

aspects of research involving human subjects. For example, universities and medical facilities with an active 

research agenda will render terms such as “institutional review boards,” “research ethics committees,” “ethical 

review panels,” “ethical review committees,” or “human research ethics committees.” According to the World 

Health Organization, a committee reviewing the ethical component of biomedical research is a

“... [g]roup of individuals who undertake the ethical review of research protocols involving humans, 

applying agreed ethical principles” (WHO, 2009).

Research involving human subjects includes

“... [a]ny social science, biomedical, behavioral or epidemiological activity that entails systematic collection 

or analysis of data with the intent to generate new knowledge; in which human beings: 

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Institutional Review Boards in the U.S.-México Border

 1) are exposed to manipulation, intervention, observation or other interaction with investigators, either 

 directly or through alteration of their environment; or

 2) become individually identifiable through investigators’ collection, preparation or use of biological 

 material or medical or other records” (WHO, 2009). 

The function of such a committee is to approve, monitor, and review research involving human participants 

with the aim of protecting the rights, safety, dignity, and welfare of the research subjects. 

The U.S. Experience 

Institutional Review Boards in the United States were first established in the early 1970s following efforts by 

the National Institutes of Health and the U.S. Public Health Service to set requirements protecting human 

subjects in all “extramural” research receiving federal funding. An event that catalyzed these efforts was the 

revelation of the Tuskegee Syphilis Study, in which 399 rural black men were left untreated for diagnosed 

syphilis even after effective antibiotics became available, which prompted Public Law 93-348 calling for 

the establishment of the National Commission for the Protection of Human Subjects of Biomedical and 

Behavioral Research (Department of Health, Education, and Welfare, 1979). In 1979 the Commission 

published general recommendations, known as the Belmont Report, that served as the basis for the 

formulation of federal regulations published in the Federal Register in 1979. The core philosophy of the 

Belmont Report centers around three principles: respect for persons, beneficence, and justice (Department of 

Health, Education, and Welfare, 1979). 

U.S. federal laws governing the ethical aspects of health and medical research have continuously evolved 

as demonstrated from the revision of existing regulations from 1974 to 1991. Currently, the Office for 

Human Research Protection (OHRP) and the Food and Drug Administration (FDA) of the Department of 

Health and Human Services (HHS) are the two agencies responsible for overseeing aspects of independent 

IRB systems. The HHS Code of Federal Regulation Title 45 CFR Part 46 condenses the regulation for 

the protection of human subjects (see Annex I). In 1991, a uniform set of regulations for the protection of 

human subjects (subpart A of 45 CFR Part 46) was adopted by other U.S. federal departments and agencies 

(Williams, 2005). This uniform set of regulations is the Basic HHS Policy for Protection of Human Research 

Subjects, informally known as the “Common Rule,” and is followed not only by HHS but also by other 

federal agencies such as the National Science Foundation, Departments of Energy, Veteran’s Affairs, and 

others (HHS, 2009). The basic HHS Policy for Protection of Human Research Subjects (45 CFR Part 46) 

applies

“...to all research involving human subjects conducted, supported or otherwise subject to regulation 

by any federal department or agency which takes appropriate administrative action to make the 

 policy applicable to such research. This includes research conducted by federal civilian employees or 

military personnel, except that each department or agency head may adopt such procedural 

modifications as may be appropriate from an administrative standpoint. It also includes research 

conducted, supported, or otherwise subject to regulation by the federal government outside the 

United States” (HHS, 2009).

Initially interpreted to mean any research directly funded by a federal agency, 45 CFR 46 did not immediately 

impact social and humanistic sciences when adopted in 1991. After the 1991 Common Rule, however, IRBs 

increasingly expanded their purview to include all research conducted in universities and colleges or in any 

federal agency, regardless of whether they were directly federally funded or not (Cohen, 2007). 

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Institutional Review Boards in the U.S.-México Border

Additionally, a number of private organizations have since voluntarily chosen to follow the Common Rule, 

though these are not subject to federal enforcement mechanisms if they fail to comply (Williams, 2005). The 

Common Rule sets out a series of guidelines which, as in practice today, affect nearly all research undertaken 

by students and faculty in U.S. colleges, universities, and federal agencies. The guidelines of 45 CRF 46 

require that all research ensures full anonymity or confidentiality to human participants (referred to as 

“human subjects”). Furthermore, all research should ensure full informed consent of participants through 

the use of written consent forms. However, there are important exemptions to these requirements. Any 

research that involves “use of educational tests, ... survey procedures, interview procedures or observation of 

public behavior” is fully exempt from IRB review according to the 45 CFR 46.101(b)(2), as long as data are 

gathered in a way that ensures the anonymity of all human participants. If participants could be identified in 

some way, or would be harmed – “at risk of criminal or civil liability ... damage[e] to ... financial standing, 

employability, or reputation” (HHS 2009: 45 CFR 46.101(b)(2)(i)), then the research is not exempt unless 

the participants potentially exposed to harm are “elected or appointed public officials or candidates for public 

office” (HHS 2009: 45 CFR 46.101.(b)(3)(i)). 

The México Experience 

In México, regulations to protect human subjects participating in scientific research is relatively new and its 

instrumentation is still a work in progress. Current practices for the protection of human subjects in hospitals 

and other medical facilities in México are based on a variety of laws and regulations. One such regulation 

is the General Law of Health (Ley General de Salud) which mandates the “creation of ethic committees in 

medical centers where research with human beings is conducted” as well as defines the functions of ethical 

committees in the Mexican heath system (see Annex II). 

Title II, Chapter I of the Regulation of the General Law of Health in Health Research (Reglamento de la 

Ley General de Salud en Materia de Investigación para la Salud) provides specific guidelines about the ethical 

aspects of medical research involving human subjects (see Annex III). Article 13 of the code states that

“...in any investigation in which humans are subjects of study, the criterion of respect for dignity and 

protection of human rights and well-being must prevail.” 

Article 14 clearly states that research involving human subjects can be conducted only

“... (a) if experimentation with lab animals or other scientific knowledge supports its relevance, (b) there 

is no other reasonable mean of obtaining similar knowledge, (c) expected benefits exceed predictable risks; 

(d) informed written consent is obtained from human subjects; (e) research is conducted by trained 

personnel with access to adequate human and material resources to provide good care of research subjects; 

and (f) have the approval of an ethics research committee.” 

Article 16 establishes

“...[r]esearchers have the obligation to protect the privacy of the persons participating in the study and 

collect identifying data only when the research design requires so and it is authorized by the subject.”

Article 18 states 

“[t]he principal investigator shall suspend research immediately in the event of foreseeable risk or damage 

to the health of the human subjects. Also, research will be suspended immediately at the request of the 

subject” (Regulation of the General Law of Health in Health Research, 1984).

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Institutional Review Boards in the U.S.-México Border

An important development in México’s efforts to regulate medical research from an ethical perspective was 

the creation of the National Commission of Bioethics (Comisión Nacional de Bioética—[CNB]). Originally 

established in 1992 by a group of Mexican scientists interested in promoting a national debate about the 

ethical implications of new biomedical technologies, the CNB became a permanent body in 2000 by 

presidential executive order and in 2005 was transformed into an autonomous and decentralized body of the 

Mexican Ministry of Health. Today the National Commission of Bioethics is

“... [t]he official body responsible for defining national policies on bioethics, for establishing public health 

policies related to bioethics and to act as the national body to be consulted on specific issues on bioethics” 

(CNB, 2009).

As it is stated in its bylaws, the mission of the CNB is to promote a bioethical culture in México. Some of the 

mandates of this institution include promoting the establishment of bioethics commissions in every state. At 

the onset of the CNB, only 9 out of 32 states had a bioethics commission. As recently as 2009, 20 states had a 

bioethics commission established.

In 2005 the CNB issued the National Guidelines for the Integration and Operation of Research Ethics 

Committees (Guía Nacional para la Integración y el Funcionamiento de los Comités de Ética en 

Investigación) (see Annex IV). These guidelines define the criteria for the integration and operation of 

ethical committees in México’s health system including hospitals, schools, and research centers. One aim of 

these guidelines is to unify the operation of ethical committees in México under a common set of rules and 

protocols. As it is stated in the guidelines, the operational criteria of ethical committees in México should 

conform to accepted international practices and be consistent with existing national regulations. The Mexican 

regulations that were considered for these guidelines include México’s Constitution, the Organic Law of the 

Public Federal Administration, the Internal Regulation of the Health Ministry, the General Law of Health, 

the Regulation of the General Law of Health related to Health Research, the Regulation of the Federal 

Commission to the Protection of the Sanitary Risk, the framework that regulates the compromise for the 

transparency in the relationship between physicians, health institutions, the pharmaceutical industry, and the 

Federal Law of Transparency and the Access to Governmental Public Information (CNB, 2005). 

Although the terms of reference of the ethical committees described in the National Guidelines apply to 

any entity conducting research with human subjects in a biomedical context, the biomedical framework in 

which this guideline is elaborated is not appropriate to settings and disciplines conducting research involving 

human subjects in social and behavioral studies. Thus, at this point the application of IRBs in universities and 

research centers conducting social and behavioral studies is much more limited. 

METHODOLOGY

The framework and operation of IRBs in the U.S.-México border was evaluated using a combination of 

methods that included a non-probabilistic online survey and a series of individual interviews with selected key 

informants. 

The survey consisted of a convenience sample of individuals affiliated with universities, medical centers, 

public health departments, and non-governmental organizations who may have been involved in public 

health research in any of the U.S.-México border states. These individuals were invited to respond to a short 

questionnaire including questions about interaction with IRBs in their institutions, perceptions of the IRB 

process, and the need for common IRB protocols in the U.S.-México border context. Informants were 

identified using a directory of health agencies compiled by the U.S.-México Border Health Commission and 

recruitment was achieved using a formal invitation sent via e-mail. The survey and all recruitment material 

6
Institutional Review Boards in the U.S.-México Border

were provided in both English and Spanish (see Annex V). The survey was posted online from December 

10, 2009, to January 30, 2010, using the services of Qualtrics Inc., an internet-based survey system (http://

www.qualtrics.com). Most of the selected participants received an initial invitation during the second week of 

December 2009 and a follow-up reminder the second week of January 2010. 

Invitations to participate in the survey were sent to a total of 104 individuals during the first recruitment 

round. Of this original list, 7 names were eliminated because they were associated with undeliverable emails 

and 4 persons refused participation due to their lack of experience on the topic of human subjects protection. 

Most of the undeliverable e-mails (n=6) were individuals who received a questionnaire in Spanish. The final 

sample consisted of 93 individuals, 25 of which received the Spanish version of the questionnaire because 

they had an affiliation to a university or institution in México, and 68 individuals received the English version 

because they had an affiliation to a university or institution in the United States. 

Fifty individuals responded to the online survey, a number that corresponds to a 54 percent response rate. 

Eleven participants responded to the survey in Spanish while 39 answered the English version. Among those 

who answered the Spanish questionnaire, 82 percent identified themselves as faculty and/or researchers 

and 18 percent as health care providers. Most of these participants were affiliated with institutions located 

in a Mexican border state (82%). Among participants on the U.S. side of the border, 74 percent identified 

themselves as faculty and/or researchers, 10 percent were graduate students, 5 percent were public health 

staff, 3 percent were health care providers, and 8 percent were directors or administrators. Most of these 

participants were part of an institution located in a U.S. border state (87%). 

The key informant interviews were conducted with a group of 7 scholars who have been involved or are 

currently involved in binational or transnational research projects. Some of the informants also possessed 

experience participating as a member of an IRB in México. A semi-structured interview of approximately 

45 minutes of duration was conducted between December and February (2009-2010) with each of these 

informants. Four interviews were conducted via telephone and the rest were conducted face-to-face. Three of 

the informants were working in a U.S. university at the moment of the interview while the rest were working 

as researchers in a Mexican university or in a health care institution. Most of the researchers (n=5) have 

approximately 20 years of experience conducting binational and/or transnational research in the U.S.-México 

border region (see Annex VI).

RESULTS

Online Survey

Most of the U.S. participants (97%) reported to have an IRB in their university, medical unit, or institution. 

Ninety-two percent of participants reported submitting a research protocol to an IRB, individually or as part 

of a research group. Around one half (54%) of U.S. participants (n=21) had participated in research projects 

involving human subjects in México although only 33 percent of these (n=7) had submitted an IRB application 

in this country. Among those who submitted an application, 4 out of 7 cases reported that their protocols 

were reviewed by more than one ethics committee, and 5 of 7 cases (71%) reported that they did not have 

access to information regarding IRB operation policies in México. An equal number of participants (n=5) who 

had experience with IRBs in México reported that their protocol was revised in a timely manner. Within this 

group, 86 percent (n=6) reported having had an academic partner in this country who facilitated the process of 

understanding and navigating IRB policies and procedures in México. 

Most of the Mexican participants (82%) reported having an IRB in their university, medical unit, or institution. 

Seventy-eight percent reported submitting a research protocol to this committee. Among Mexican scholars, 36 

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Institutional Review Boards in the U.S.-México Border

percent (n=4) had participated in research projects involving human subjects in the United States and 75 percent 

(n=3) had submitted an IRB application in this country. Among those who submitted an IRB application, 2 out 

of 3 cases reported that their proposals were reviewed by more than one ethical committee and 1 out of 3 cases 

reported that they did not have access to information regarding IRB operation policies in the United States. In all 

the cases where a protocol was submitted to an IRB in the United States, the decision was announced in a timely 

manner. Mexican scholars who submitted an application to an IRB in the United States reported having had an 

academic partner in this country who facilitated the process of understanding IRB policies and procedures.

Interviews

Interviewed participants classified university and research center IRBs into three categories: a) schools or 

research centers that have a permanent IRB with a well established review protocol and mechanism, b) schools 

or research centers using ad hoc IRBs, and c) schools or research centers that do not have an IRB. In general, 

the first category is common among schools or centers conducting research in the biomedical area while the 

last two categories dominate schools or research centers conducting research in the social and behavioral 

sciences. In contrast to Mexican institutions, U.S. universities, community colleges, and research centers have 

a well established IRB protocol that applies to all research involving human subjects in the biomedical, social, 

and behavioral sciences.

The knowledge level of IRB operations was assessed among participants in the interviews. Among Mexican 

scholars, the knowledge level of current IRB practices in both México and the United States correlated with 

two factors: (a) participation as co-principal investigators in a binational project and (b) exposure to the 

IRB process while completing regular coursework in a U.S. university as a graduate student or in short-term 

training programs in the United States. On the other hand, the knowledge level of Mexican IRB operations 

among U.S. researchers correlated with having a specific project in México or having a Mexican colleague who 

introduced them to the Mexican IRB process. 

Interviewed participants provided valuable information and insight about their experience with the IRB 

process both in México and in the United States. Their experiences are summarized below through the 

narrative of nine specific cases illustrating challenges and coping strategies adopted by scholars on both sides 

of the border. 

Case Studies

Case 1: Alternatives to IRBs and limitations

During the interviews, a common barrier identified by U.S. scholars conducting research in México was their 

inability to find a university or research center with an established IRB. Even when these researchers came to 

México with a protocol previously approved by a U.S. university, they were required by their funding agency or 

university to obtain approval of the same protocol by a Mexican IRB. Under this circumstance, the inability to 

find established IRBs in México forces improvisation as illustrated by a U.S. researcher. Because the Mexican 

university where one participant was a visiting scholar did not have an IRB, this participant had to request 

from the home university authorization to use letters of support signed by the head and faculty of the host 

university in México as a substitute for a full IRB review. The submission of letters of support from Mexican 

universities or hospitals in lieu of an IRB approval is an extended practice among U.S. scholars conducting 

research in México. This practice became common because IRBs in U.S. universities recognize the existing 

national disparities in this area and accept such documentation as an acceptable substitute of an IRB review 

in México. Yet, access to this mechanism is limited by the existence of prior collaboration and networking. As 

explained during the interview, the participant did not face too many barriers obtaining support letters because 

this individual already had a strong connection with the Mexican academic community. These networks 

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Institutional Review Boards in the U.S.-México Border

enormously facilitated the research process since Mexican researchers were critical to connect the participant 

with the community, local authorities, and other key research stakeholders. In the opinion of this participant, 

acceptance of his/her research by the community and collecting data in México was completely dependent 

on the support that his/her project obtained from Mexican researchers. This participant is a U.S. scholar with 

almost 20 years of experience conducting research in northwest México. 

Case 2: Long-term impact through IRB training

According to U.S. scholars, binational research can be a challenging process for participating institutions, 

especially in those disciplines where no tradition exists for human subjects protection provisions. Therefore, the 

process of establishing an IRB in a Mexican university with a social science program could take months and 

even years. According to two participants, this situation is a deterrent for binational projects as many scholars 

might not be willing to bear the burden of a time consuming, complex, and uncertain bureaucratic process. 

When describing the experience with a binational project in northern México, one participant stated that 

the university and its partner in México agreed on investing time and money in training human resources in 

research ethics. Both principal investigators wanted to be sure that their project would cover the requirement 

of the HHS regulation for the protection of human subjects (45 CFR part 46), so the team decided to send a 

Mexican scholar to a short training program in research ethics at a U.S. university. According to this scholar, 

training of local human resources is critical in the process of developing and establishing an IRB in Mexican 

universities. After the IRB was established, this Mexican university obtained an HHS-approval assurance, 

which was a requirement to release U.S. federal government resources for this particular project. This is a 

scholar with almost 20 years of experience conducting research in northern and central México. 

Case 3: Ad Hoc IRBs

Since most Mexican universities and research centers do not have an IRB and frequently researchers in 

these institutions are required to demonstrate that their institutions have this type of committee, Mexican 

institutions often resort to creating ad hoc IRBs. Funding for binational projects provides the conditions 

that usually will derive in the establishment of an ad hoc ethical committee in Mexican institutions. While 

this practice often positively results in solving an existing need, it also bears some limitations. First, the 

possibility of utilizing an IRB process is unknown by most researchers as demonstrated by the fact that in 

some Mexican institutions, a group of researchers reported the existence of an IRB while other researchers in 

the same institution were not able to confirm the operation of such a committee. Second, ad hoc committees 

tend to be temporal and their operation is unlikely to transform existing human protection practices within 

the institution. Third, criteria for the integration of an IRB are unclear and their operation many times is 

based on convenience. The operation of an ad hoc IRB is promoted in most of the cases by researchers in the 

health-related area and its operation might be temporal. 

Case 4: Balancing the IRB review process

A U.S. scholar noted that when a research protocol is reviewed by an IRB, it is important to differentiate the 

methodological aspects from the ethical dimensions of the research process. On the one hand, all the issues 

related to the scientific integrity of the study are placed on the relationship between research design and data 

quality. On the other hand, there are ethical issues of protecting human subjects that should be given equal 

weight and attention. According to this scholar, Mexican ethic research committees put more emphasis on the 

design aspect of research protocols and less on human subjects protection. This scholar further commented 

that it is important that each component of the research process be assessed independently and impartially, so 

reviews properly weigh the risks and benefits for participants. It is imperative that measures for protection of 

human subjects be clearly defined in the research design and be systematically evaluated by IRBs.

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Institutional Review Boards in the U.S.-México Border

Case 5: IRBs and social/behavioral studies

Several researchers agreed on the necessity of developing and establishing IRBs in Mexican schools and 

research centers conducting social and behavioral studies. Studies conducted in social science institutions 

usually involve topics and situations in which the physical and emotional integrity of participants might be at 

risk, and these components need to be thoroughly evaluated before the start of the study. Some examples of 

such studies are projects addressing domestic violence, use of illegal drugs, and sexual behavior. Participants 

emphasized studies in these areas might be a source of stress among human subjects, and in extreme 

circumstances, they could even produce life-threatening situations for particularly vulnerable individuals. 

For instance, a woman disclosing physical domestic violence could be at risk of experiencing more violence if 

researchers are oblivious of the environment in which the interviews are conducted or are careless about the 

level of privacy required for this type of investigation. On the other hand, there are some topics that could 

impose an unacceptable level of risk to the integrity of interviewers, such as studies about the use of illegal 

substances or drug trafficking. In these cases, it is critical that an independent collegiate group, such as an 

ethical committee, review and assess the risk benefit of a particular study before the start of fieldwork. 

Case 6: Culturally sensitive IRBs

There was consensus among participants regarding the use of written informed consent in studies in which 

some level of risk might exist for human subjects. These included any biomedical, social, and behavioral 

studies where biological samples and anthropometric measurements would be collected from human subjects 

or where the efficacy of any treatment would be tested. This also should apply to studies where vulnerable 

groups are the target population (children, pregnant women, prison inmates, people with mental disabilities, 

etc.). Any exception to this rule should be decided by an ethical committee and should not be left to the 

discretion of individual researchers. However, ethical committees should be cognizant of different institutional 

and cultural traditions in México and the United States. Under some circumstances, binational projects could 

be problematic because IRB procedures in U.S. universities can be prolonged and because some procedures 

to protect subjects might be difficult to implement in some Mexican contexts. For instance, anthropologists 

of both countries agreed that they had faced barriers to apply certain techniques and tools when the U.S. 

protocols required the collection of a written informed consent. Signing any type of document might be 

considered unacceptable in contexts where people do not trust formal institutions. This is something that 

goes beyond the level of rapport that an interviewer can have with a participant. Indeed it is something more 

related with the fact that some people believe that if they sign a document, this document might be used 

legally against them. It is also a factor related with participants’ education levels because in some cases they 

are not able to read and write. Thus, this group of researchers suggested using a verbal informed consent 

procedure. This includes using adequate language and spending enough time with participants to inform 

them about the risks and benefits of the study. 

Case 7: U.S. researchers working in México without an IRB

A Mexican scholar described the situation in which he/she was invited by the ethics committee of a local 

health department to review a research protocol of a U.S. team that was collecting data in a Mexican 

community in northern México. According to this scholar, some members of the community were 

uncomfortable with the topic and the questions that these U.S. researchers were asking. This prompted 

the creation of an ad hoc committee to evaluate the research protocol. After reviewing the protocol of this 

ongoing study, the committee decided not to approve it. Some of the reasons why this protocol was not 

accepted were the following: a) the U.S. team was collecting data about a sensitive topic (sexuality) among 

indigenous adolescents, and some members of the community did not feel comfortable with how adolescents 

had been approached, b) the study included a clinical component, where a physical exam required touching 

private areas of the adolescents’ body, and c) the team offered program incentives to the participants which 

included gifts. Since this is not a common practice among Mexican researchers, this particular component 

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Institutional Review Boards in the U.S.-México Border

was identified as a form of bribery by some members of the community. The combination of these factors, 

along with the fact that the study was not considering the community’s customs, provided the basis for the 

rejection of the protocol. This case illustrates the situation of a transnational study in which U.S. researchers 

were conducting research in México without connecting with any type of Mexican institution or Mexican 

researchers.

Case 8: Mexican researchers working in the U.S. without an IRB

A U.S. scholar described the situation of a team of Mexican researchers conducting research in the United 

States without establishing any type of formal connection with U.S. scholars or institutions. According to this 

scholar, a team of Mexican researchers and their students conducted a survey among individuals of Mexican 

origin in a U.S. border state. This circumstance raised concerns about whether this team had an approved IRB 

by a Mexican university and whether the IRB included a protocol of proper collection of biomedical samples 

from participants. It was apparent from this experience that there is a lack of information among Mexican 

researchers regarding IRBs and the risks of transnational research for human subjects. This situation illustrates 

the importance of having a collaborative partner across the border and highlights the need for a binational 

IRB framework. 

Case 9: Social responsibility

The impact of research on the well-being of communities was also a point of discussion for some researchers. 

Scholars conducting research at the binational or transnational level have a social responsibility with both 

participants and communities. Some of these responsibilities include providing the community with feedback 

about major findings and recommending potential policy actions that might contribute to improve the 

well-being of the participants and their communities. Binational research should also provide opportunities 

for the development of local capacities. Thus, external sponsored projects offer an excellent opportunity to 

build capacities among students, community advocates, and other researchers in border communities. Given 

the economic asymmetry between México and the United States, any collaborative project should assure 

Mexican scholars full access to any data collected as part of the research activities. During the interviews, it 

was suggested the research findings resulting from projects conducted in México have a higher marginal value 

in México than in the United States. Thus, it is critical that any data or research result generated through 

collaborative projects be presented and discussed in Mexican forums as well.

OBSERVATIONS AND RECOMMENDATIONS

Research Ethics Issues in National and Binational Contexts 

An important number of observations and recommendations were expressed by participants in the survey and 

the interviews. Approximately 54 percent of participants in both surveys provided some recommendations 

about how to improve the IRB review process in México and/or in the United States. Only 10 percent of the 

U.S. survey participants reported not having information about IRB operations in México. The following 

list provides a synthetic view of the main areas of concern and opportunity for IRB operations in the U.S.-

México border according to the participants. 

IRBs in México

1. Widely disseminate existing Mexican regulations to protect human subjects participating in medical 

research. 

2. Develop IRB guidelines and procedures. These should include information about IRB membership, IRB 

11
Institutional Review Boards in the U.S.-México Border

procedures, and training of members. It is critical to include a clear description of the review process defining 

the amount of time required by the IRB to evaluate research protocols. 

3. Implement a web-based IRB submission facility. This includes making forms available electronically. 

Securing Spanish-English translations of IRB guidelines and tools is recommended.

4. Establish a transparent and harmonized review process so approval of research protocols can be accepted 

by any IRB in the border region. This will eliminate the need for a double IRB submission as is required in 

some instances in México.

5. Encourage the establishment of human subjects sections in Mexican universities and research centers 

without an IRB. It is also important to create and disseminate a directory of Mexican research institutions 

with IRBs in place.

6. Develop an ongoing web-based training program for researchers conducting studies involving human 

subjects. The program can be modeled after the Collaborative Institutional Training Initiative (CITI) or other 

similar programs. 

7. Create a protocol to allow IRB clearances in México when projects have an approved IRB from a U.S. 

university.

8. Create a panel of specialists to design an IRB policy in México responsive to the necessities and culture of 

research in México.

IRBs in the United States

1. Streamline the IRB process and develop protocols that are better suited for social and behavioral sciences. 

Some current IRB practices appear to apply to clinical/product studies but do not seem to be applicable for 

field-based environmental epidemiology. 

2. Design consent forms that do not just meet legal requirements and protect universities from liability 

but also include language that is understandable and sensitive to the concerns and customs of participants. 

Consent forms enforced by the IRB of some U.S. institutions are difficult to use in Mexican communities.

3. Renew letters provided by Mexican institutions to support projects of U.S. researchers every year 

regardless the researcher in charge.

4. Clearly define the amount of time required to evaluate binational research protocols since these types of 

projects tend to take more time to review compared to domestic projects.

5. Expand IRB personnel to provide timely review of protocols submitted for approval.

6. Provide basic information about IRB guidelines and tools in Spanish.

7. Provide counseling to external institutions about IRB operation and certification by HHS. 

Guidelines for joint IRBs

1. Establish a clearinghouse that can be used by researchers on both sides of the border. This clearinghouse 

should provide uniform IRB guidelines for binational research projects.

2. Promote the establishment of a system that can be utilized for IRB submissions in the U.S.-México 

border. 

12
Institutional Review Boards in the U.S.-México Border

3. Promote collaboration among academic institutions to discuss protection of human subjects at the 

binational level. The National Council of Science and Technology (CONACYT) of México and the National 

Institutes of Health (NIH) should develop and establish guidelines for joint IRBs. Canadian universities 

should also be included in this discussion.

4. Promote the exchange of experiences between Mexican and U.S. researchers about IRB frameworks and 

operations. This exchange should discuss aspects such as enforcement and monitoring of protection of human 

subjects in binational and transnational projects.

5. Learn from the experience of researchers conducting binational or transnational studies. Some researchers 

of both countries have developed strategies to work collaboratively complying with IRB requirements. For 

instance, researchers divide the research process between countries. Thus, while the field work and data 

collection is conducted in México under the supervision of Mexican researchers, the processing of data takes 

place in the United States. Under this model, U.S. researchers receive IRB approval from their institution to 

conduct secondary data analysis. 

6. Promote the U.S.-México Border Health Commission as the logical platform to launch a binational 

discussion about IRB protocols in México and the United States and the need to mediate existing frameworks 

and practices. 

Suggested Actions for the U.S.-México Border Health Commission 

1. Distribute the IRB report to chief research officers at each of the institutions of higher education and 

health departments with emphasis on those located on the U.S.-México border.

2. Organize a media campaign to optimize distribution of the IRB report to faculty and clinicians who are 

engaged or may be considering engaging in binational research in México and the United States.

3. Disseminate the IRB report using all the U.S.-México Border Health Commission communication 

resources such as the E-Border Health bulletin and the website. When posted on the website, it would 

be critical to track the number of “hits” or access events to this document to estimate the level of report 

dissemination.

4. Secure English-Spanish translations of the IRB report to facilitate the discussion of this document among 

a broad group of Mexicans, including undergraduate and graduate students, health providers, and health staff. 

5. Promote collaboration among academic institutions to discuss protection of human subjects at the 

binational and transnational level. México’s CONACYT and the U.S. NIH should develop and establish 

guidelines for joint IRBs.

6. Promote the exchange of experiences between Mexican and U.S. researchers about IRB frameworks and 

operations. This exchange should cover aspects such as enforcement and monitoring of protection of human 

subjects in binational and transnational projects.

7. Promote the organization of conferences among universities and research centers located along the U.S.-

México border to begin discussion of current U.S. and México IRB protocols and practices and the possibility 

to develop and establish guidelines for joint IRBs.

CONCLUSION 

While IRBs are a vital instrument in conducting research across international borders and in protecting 

human subjects, applying IRB processes in other countries can sometimes become especially complicated, 

13
Institutional Review Boards in the U.S.-México Border

involving other cultural and legal considerations not initially realized. Thus, to better address these 

issues and concerns with respect to the United States and México, this report demonstrates, beyond the 

recommendations delineated above, a need to develop common guidelines for IRB operation or the 

establishment of binational protocols applicable on both sides of the border. 

14
References

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investigacion para la salud. México City: Diario Oficial de la Federación. 

Cámara de Diputados del Congreso de la Unión. (1984). Ley general de salud. México City: Diario Oficial de 

la Federación. 

Cohen, P. (2007, February 28). As ethics panels expand grip, no field is off limits. The New York Times. 

Retrieved from http://www.nytimes.com/2007/02/28/arts/28board.html. 

Comisión Nacional de Bioetica. (2005). Guía nacional para la integración y el funcionamiento de los comités de 

ética en investigación. Guadalajara, Jalisco: Secretaría de Salud de México. Retrieved from 

http://www.cnb-mexico.salud.gob.mx/interior/temasgeneral/presentacionguias.html. 

Comisión Nacional de Bioetica. (2009). ¿Qué es la comisión nacional de bioética? Retrieved from 

http://www.cnb-mexico.salud.gob.mx/interior/queeslacomision.html#. 

Department of Health and Human Services. (2009). Code of federal regulations, title 45 public welfare part 46, 

protection of human subjects. Retrieved from 

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. 

Department of Health, Education, and Welfare. (1979). The belmont report: Ethical principles and guidelines 

for the protection of human subjects of research. Retrieved from 

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm.

World Health Organization. (2000). Operational guidelines for ethics committees that review biomedical research. 

Geneva: World Health Organization. Retrieved from 

http://www.searo.who.int/LinkFiles/RPC_Operational_Guidlines_Ethics.pdf. 

World Health Organization. (2009). Research ethics committees: Basic concepts for capacity-building. Geneva: 

WHO Document Production Services. Retrieved from 

http://www.who.int/eth/Ethics_basic_concepts_ENG.pdf. 

World Medical Association. (1964). Declaration of Helsinki. Retrieved from 

http://ohsr.od.nih.gov/guidelines/helsinki.html. 

Williams, E.D. (2005). Federal protection for human research subjects: An analysis of the common rule and its 

interactions with FDA regulations and the HIPAA privacy rule. Congressional Research Service Report for 

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http://www.fas.org/sgp/crs/misc/RL32909.pdf. 

15

Institutional Review Boards in the U.S.-México Border
Annexes

Annex I: Code of Federal Regulations (CFR) Title 45 Public Welfare, U.S. Department of Health and 

Human Services (HHS), Part 46 Protection of Human Rights

http://www.borderhealth.org/files/res_1733.pdf

Annex II: Ley General de Salud

http://www.borderhealth.org/files/res_1734.pdf

Annex III: Reglamento de la Ley General de Salud en Materia de Investigación para la Salud 

http://www.borderhealth.org/files/res_1735.pdf

Annex IV: Guía Nacional para la Integración y el Funcionamiento de los Comités de Ética en Investigación

http://www.borderhealth.org/files/res_1736.pdf

Annex V: Institutional Review Boards in the U.S.-México Border: Current Protocols and Practices Report 

Study Questionnaires

http://www.borderhealth.org/files/res_1737.pdf

Annex VI: Interviewed Participants

http://www.borderhealth.org/files/res_1738.pdf 

Credits

A special thanks to Maria Hilda García-Pérez, Ph.D., Assistant Professor, School of Transborder Studies, 

College of Liberal Arts and Sciences, Arizona State University, for her invaluable research, writing, and 

consultation provided to this project. 

16
For additional information please visit our website at www.borderhealth.org.

Unites States-México 

Border Health Commission

211 N. Florence, Suite 101

El Paso, TX 79901

Tel: (915) 532-1006

Fax: (915) 532-1697

Toll Free (866) 785-9867

www.borderhealth.org

Comisión de Salud Fronteriza

México-Estados Unidos

Avenida Durango No. 247, 4o piso

Col. Roma Norte, Delegación Cuauhtémoc

C.P. 06700 México, D.F.

Tel./Fax (01152-55) 3611-0765

www.saludfronteriza.org.mx