Guidelines for conducting research within structures and gatekeepers

Off-campus research that involves recruitment of participants from physical or social structures must address specific issues:

• Recruiting  that involves permissions at different levels or stages    
• Recruiting that involves complex procedures
• Obtaining ethics clearance from more than one Research Ethics Board(s), or obtaining permission from a committee and a gatekeeper
• Respecting the culture of the structure
• Learning and following the applicable rules and regulations of the structure
• Training and supervision of student researchers and research assistants
• Assessing risks to researchers and implementing safeguards
• Providing research feedback to members of the structure

These issues are relevant also to research conducted via e-mail or the internet with participants who are not Waterloo faculty, staff, or students.  These issues will be expanded upon in the following sections.

Approval process and participant recruitment

The size and/or type of the physical or social structure often influence the complexity of the approval process and the participant recruitment procedures.   For almost all structures, the process most often involves permission or endorsement from a ‘gatekeeper(s)’ or ‘oversight representative’ before recruitment of study participants can begin.  

In general, the vulnerability of the persons in the structure and the commonness of research activity within the structure are related to the complexity of the approval process and the recruitment process.  As involvement in research increases, a structure is more likely to have involvement in research that poses a range of risks to research participants.

The approval and recruitment process for different structures can be assimilated into three categories.  All three cases involve a gatekeeper.

A gatekeeper is someone who controls access to a structure or section of a structure; for example, a band chief, administrator of a long-term care home, school principal, or director of an organization.

Types of approval and recruitment procedures within structures

Research Ethics Boards approval, gatekeeper endorsement or permission, and assistance with recruitment

Facilities or institutions such as hospitals, long-term care homes, health units, school boards, and universities often have an internal research ethics board (REB). Ethics clearance must be obtained from their REB in addition to ethics clearance through the Waterloo REB for research conducted in their facility. In these situations it is advised that the ethics applications be submitted simultaneously or that application is first made to the Waterloo REB and comments obtained before submitting to the site(s) REB.  Permission or endorsement from a gatekeeper, for example, a senior administrator, a manager, or floor supervisor at each site may need to be obtained to be able to recruit participants once ethics clearance has been obtained from each structure’s REB. 

If study procedures involve staff and/or use of space or equipment, then it is recommended the entire protocol details be discussed with the gatekeeper and permissions obtained prior to submitting an ethics application to the REB(s). If the structure’s staff is involved in conducting the study, then the manager has to agree that they can use their time in this way. The gatekeeper may recommend changes to the recruitment process and/or procedures, say, to minimize involvement time for participants. Ethics clearance must be obtained before the project can proceed. Often, one of the project’s co-investigators or a collaborator is also a gatekeeper.

Normally researchers do not contact vulnerable persons directly but through a gatekeeper. The way in which the gatekeeper is involved will depend on the gatekeeper’s relation to potential participants; for example, if s/he is directly involved in their care or the gatekeeper is perceived as an authority figure. A gatekeeper could, for example,

• provide information letters to potential participants with interested persons then contacting the researcher directly
• with permission from the potential participant, provide contact information to the researcher
• allow the researcher to place recruitment posters in their office.

Examples:

1. In a study examining a therapeutic art therapy program for trauma clients post-discharge from a hospital, the researcher undertook the following approval and recruitment process:

• Obtained ethics clearance through the Waterloo REB
• Obtained ethics clearance through the REB for the hospital
• Obtained permission and assistance from the Art Therapist (i.e., gatekeeper) at the hospital
• The Art Therapist sent the information letter to potential participants’ home addresses on behalf of the researcher and then called the potential participants to further discuss the project and ask about their interest concerning participation in the study

2. In a secondary data analysis study of clinical assessment data, collected as part of standard clinical practice, the researchers carried out the following approval process:

• Obtained ethics clearance through the Waterloo REB
• Obtained ethics clearance through the REB for each facility
• Obtained permission and assistance from a manager at each facility for the specific patient chart data, who coordinated sending de-identified data to the researcher

Committee approval, gatekeeper endorsement or permission, and assistance with recruitment

Some structures may not have an REB but a committee that determines whether the research can take place within their structure. Subsequent to Waterloo REB approval, approval must be obtained via this committee before recruitment of participants can begin. Once approval has been given, a member of this committee may provide guidance and/or endorsement for conducting the research within the structure and may provide input to the recruitment process. Then again, after committee approval there may be persons within the structure who are gatekeepers and their endorsement and collaboration are required.

As in the previous situation involving REB approval, a gatekeeper is usually involved in recruitment by, for example, recruiting directly or recommending persons (e.g., staff) for the researchers, obtaining permission from potential participants to provide contact information to the researchers, or providing potential participants with researcher contact information.

Examples:

1. In a survey of and focus groups with Aboriginal persons in the North, the researchers did the following to obtain approval and recruit participants.

• Obtained ethics clearance through the Waterloo REB
• Obtained a Scientific Research License for conducting research in the North  
• Contacted chiefs and community leaders in all areas in the north where the survey was to be conducted; obtained approval from chiefs and leaders and asked for guidance and assistance with recruitment of participants from their community
• Chiefs and Leaders were involved in the focus groups which were called Talking Circles

2.   To conduct research in elementary or secondary schools, researchers first obtain ethics clearance through the Waterloo REB, then approval from the school board and the school principals. Information letters and parent permission forms are sent home via the children or mailed by the school with prepared stamped envelopes that contain the information letter and permission form. The school staff affixes mailing labels (and usually the researcher provides the labels or covers the cost) to the letters. Some boards do ask the researcher to contact the school principals first; however, this is not common. The ORE liaises with the Waterloo Region and Waterloo Catholic District Schools for researchers; however the researchers obtain permissions from principals of schools assigned by the school board.

Gatekeeper endorsement or permission and potential assistance with recruitment

For many structures, an REB or committee does not exist and the researcher must obtain permission to contact potential participants via gatekeepers (e.g., facility administrator, a senior manager, an organization’s director). Potential participants need to know that permission was given by a gatekeeper in the structure for conducting the study and, for example:

• if they choose to participate, participation can be done during work hours (or not)
• participation is not part of their usual activities or care within the structure
• participation or non-participation will not affect the level of services or care being provided

The gatekeeper(s) may need to send out information letters or e-mails on behalf of the researchers in order to protect the privacy of the structure’s members.  Acceptances or enquires by potential participants would be received by the researcher. 

If contact information for the potential participants is not publicly available and potential participants are members of an organization, customers, residents, students, etc. then under the Canadian Personal Information Protect and Electronic Documents Act (PIPEDA) and the Ontario Freedom of Information and Protection of Privacy Act (FIPPA) contact information cannot be provided to the researchers unless permission has been given by the individuals.

Examples:

1.   For a course project students wanted to survey customers at St. Jacob’s market and Kitchener market. After obtaining ethics clearance through the uWaterloo ORE, the students contacted, by phone, the manager for each market.  They provided each manager with information about their study and asked if they could recruit customers at the market for their 3-minute survey concerning farm produce.  They provided the managers with the dates, times, and number of student researchers and a copy of their questionnaire.

Note:  if more than one project involved either of the markets, the course instructor contacted the manager and provided information on the different projects and when they would be occurring.

2.   In order to develop an assistive device designed to help persons who cannot feed themselves, the researchers wished to unobtrusively observe persons (e.g., who were unable to feed themselves). The researchers:

• Obtained ethics clearance through the Waterloo REB
• Applied to work as a volunteer in a long-term care home and provided a letter to the manager of volunteers outlining the researcher’s study and that while they were carrying out their volunteer duties they would also be using their unobtrusive observations of residents being fed at the facility to assist with their assistive device design

3.   Researchers wanted to survey employees of an insurance company via a web-survey. The survey included items about employee satisfaction.  However, even though employee e-mails were available on the company website, they were for company purposes. The researchers undertook the following for approval and recruitment.

• Obtained ethics clearance through the Waterloo REB
• Sent a letter to a senior manager of the insurance company outlining the study, requested permission to contact employees via e-mail concerning the study which would include a link to the web-survey
• Sent an e-mail to company employees, which was the information letter for the study. The message stated that the study was not being conducted for the company and that the survey was not to be completed during work (this was at the request of the manager)

Obtaining approval and recruiting participants in a physical or social structure

Whenever a research project involves recruitment within a physical or social structure the researcher needs to determine who would be the most appropriate gatekeeper.  This is not always clear and may take several attempts.  With ongoing research within a physical or social structure the researcher becomes experienced at recognizing who is the best contact or gatekeeper, who should be included in the approval process (and who should not) and most importantly builds relationships and partnerships.  Quite often students benefit from their supervisor’s or senior research staff’s experience with particular structures.

The timing for contacting a gatekeeper for the structure will depend on the research project.  If the project involves recruiting vulnerable persons and/or there are risks associated with the procedures, then contact with a gatekeeper should be made months before the planned time for recruitment.  The gatekeeper will be able to provide the researcher with information concerning the feasibility of conducting the study (in that particular structure); the approval process, if there is a Research Ethics Board; recommended recruitment procedures, and possibility of assistance with recruitment.  Quite often this type of coordination planning occurs before a research ethics application is submitted to the ORE and to the REB of the structure.

For studies that do not involve vulnerable participants and pose no known or anticipated risks, such a long pre-recruitment planning period is unlikely to be necessary. However, the time to contact a gatekeeper, discuss the project, and obtain approvals before recruiting participants must be taken into account. The research ethics application for a project of this type is usually submitted and ethics clearance obtained before contacting the gatekeeper.   However, if the researcher or others believe there is uncertainty the gatekeeper will give approval/permission; the protocol involves, say, the structure’s staff, equipment, or space; or there is the possibility of modifying the study plans to address the structure’s research questions/needs, then early contact and discussion with the gatekeeper would be prudent and may be made before submission of the ORE application.

Undergraduate Course Projects

For undergraduate course projects to be carried out in institutions, agencies, facilities, government departments, or businesses, the course instructor is to obtain approval/permission from each organization prior to submitting the ethics application for the course projects (or prior to the students submitting their ethics applications). 

Written evidence of the approvals/permissions are to be submitted with the application form to the Office of Research Ethics.

For more information concerning student research refer to the guidelines and policies.

Gatekeepers and estimated time for approval within structures

Culture and rules

Corporate culture is the set of shared attitudes, values, goals, and practices that characterizes a company or corporation. Culture is the customary beliefs, social forms, and material traits of a racial, religious, or social group.

The Corporate in Corporate Culture may not always apply when conducting research within a physical or social structure but Culture does. 

The culture of a structure will not be found neatly laid out in a binder; however rules, regulations, guidelines, protocols, or philosophy are likely to be. Researchers should explicitly ask about applicable rules, regulations, and protocols that they should be aware of while recruiting and conducting research within the structure.

Researchers need to be aware that structures have their own culture and professional standards. Being cognizant of the culture may aid in the approval/endorsement of the project (e.g., how does the project fit within the culture; its goals and practices) and with recruitment of participants.  For example, what eail format should an outsider use with members of the structure; which clothing attire conforms to the professional standards and/or demonstrates respect.  

Recommendations for student researchers

• Discuss with your faculty supervisor what s/he knows about the culture and the protocols and guidelines of the structure
• Determine if a police check is needed before contact is made with participants within the structure; a police check is usually necessary for one-to-one contact with school children, persons with intellectual disabilities, and persons involved in the criminal justice system
• Arrange for a face-to-face meeting with the administrator, manager, director, or chief of the structure to learn about the applicable protocols, guidelines, and/or regulations that are relevant to you while in the structure conducting your research and when interacting with, for example,  staff and residents, patients, students, members, or clients
• Adopt a professional dress code while within the structure, when unsure of the dress code.  The dress code may be influenced by the nature of the structure. For example, wearing blue jeans and a t-shirt can be considered disrespectful by residents of long-term care homes, whereas a suit and tie may not be appropriate for a construction site
• Use a formal mode of communication (e.g., address people as Ms., Mr., or Dr.; always ask permission to do things, such as look at books, papers, pictures, go into an area of the structure, or residents’ rooms) 

The following are for business etiquette; however they do apply to researchers conducting off-campus research:

E-mail etiquette

Meeting & Greeting

International research and research in the North

Culture can impact greatly the procedures for a research study. If procedures do not take into account cultural differences then research questions may not be addressed and there may be risks to participants. Culture, amongst other characteristics of a structure or country, must be recognized, and responded to in research. 

Waterloo researchers conducting research outside of North America should have a collaborator or co-investigator within the country where the research will be conducted. Often the collaborator is a colleague at a university within the country. Typically, the collaborator is knowledgeable of, for example, the culture, language, political situation, and risks to participants and the researcher. Often this person assists, directly or indirectly, with recruitment of participants, which may involve local gatekeepers, such as village chiefs.  Some researchers, with extensive familiarity with the country where the research will be conducted, will not need a collaborator.

Student researchers planning to conduct their research in a country, which is not their native country and which is outside of North America, are to take part in the Pre-Departure Program offered by the Waterloo International  Office; contact Drew Knight, Director.

Student researchers are to obtain ethics clearance through the Waterloo REB for their project before leaving Waterloo for the country where the research will be conducted. The collaborator for the project is to be identified on the application form and it is expected that recruitment plans and procedures for the study were developed in collaboration with the collaborator.

A country, outside of North America, may have regulations for conducting research by foreign researchers. The researcher must determine if there are any regulations and respond to the requirements (e.g., collaborator within the country, submission of an application) for their research study. An application (to the country) may need to be submitted three months prior to starting the research.

The Harvard School of Public Health has a listing of regulations for some countries. The Global Research Ethics Map was started recently and is being updated with additional countries. The regulations for Thailand are not included yet in the Research Ethics Map

Northern Canada

To conduct research in Northern Canada a Scientific Research License is required. The application for the license is to be submitted at least 120 days prior to the research commencement date.

Assessing risks to researchers

A gatekeeper may help to identify and lessen any risks to the researcher that might be associated with off-campus research.

For some off-campus research projects that involve human participants there are no defined structures and consequently no gatekeepers. In these situations there may be risks to the researchers. For example, researchers conducting surveys or using other research methods in known high-risk neighbourhoods or isolated areas.

Recommendations for student researchers

• Review with your faculty supervisor or course instructor the study procedures and proposed methods of collecting data from the perspective of what could pose possible risks to yourself as a student researcher and assess whether or not you and your supervisor wish to accept these risks.  If you decide to do so, then develop safeguards with your supervisor
• Work in pairs when conducting research in neighbourhoods or isolated areas
• Carry a cell phone
• Consider checking in and checking out with a colleague, family member or friend so someone knows where you are at all times
• Only go into controlled or restricted access areas accompanied by someone who has the authority to be in the area, and/or with clear authorization for you to be in the area

Training and supervision of students and research assistants

Faculty supervisors and course instructors (for students conducting course projects) are expected to provide coaching or training for students who plan to conduct off-campus research so they are well informed about the population from which they intend to recruit, and are knowledgeable of the structure in which they plan to conduct their research.

The faculty supervisor or course instructor provides his/her students with the skills and knowledge based on his/her own experience, or that of colleagues, of the “best” methods for approaching gatekeepers (who may be managers, administrators, supervisors, doctors, medical directors, or chiefs) and the potential participants (who may be band members, patients, residents of long-term care homes, students, employees, customers, or clients).

Students should be knowledgeable of and have developed the skills associated with the proposed research methods (e.g., interviews, questionnaire). They should be able to provide evidence of this via research methods course(s) within their department or faculty, or outside the faculty if appropriate. This evidence is to be provided in the research ethics application.

Faculty supervisors and course instructors are responsible for providing ongoing supervision of students while they conduct research on or off campus. This involves having a plan in place for ensuring that regular consultations on progress with the study occur, as well as approaches for dealing with unforeseen situations. Often student researchers are supervised by staff within the structure for such places as long-term care homes, schools, and hospitals. However, this does not supersede the supervisor’s responsibilities.

Training and supervision by the faculty member also applies to research assistants.

There are specific Waterloo Safety Guidelines for Field Work/Field Trips in International Locations. The researcher/field work supervisor must anticipate health and/or safety risks associated with a field work activity and identify means to mitigate these risks. The University of Waterloo requires the field work researcher/supervisor to complete a Field Work Risk Management Form which must be approved by their supervisor prior to the expected date of the trip (ideally two weeks in advance).

Feedback and giving back to the structure

Study results or feedback should always be provided to the gatekeeper or other representative for the structure. It is recommended, when possible, that the researcher provide a report specific to the structure, unless the number of participants is small and/or there may be a breach of confidentiality. If there are negative findings concerning the structure, these should be presented constructively. Feedback can be given in different ways; for example, via a presentation, or during an event.

The researcher should consider giving back to the community, particularly in the case of vulnerable communities. This could be done, for example, through education and training or providing an honorarium to the community which could be used for equipment, resources, programs, or training.

Critical Inquiry

Careful consideration is needed when conducting critical inquiry research involving the analysis of social structures or activities, public policies, or other social phenomena.

When the objective of the research is to investigate critically an institution, organization or other entity, and the institution, organization or entity may not be aware of or support the research this should not prevent the research from being conducted. The TCPS2, Article 3.6, outlines that "permission is not required from an organization in order to conduct research on that organization." However, if "a researcher engages the participation of members of an organization without the organization's permission, the researcher shall inform potential participants of any foreseeable risk that may be posed by their participation".

There are specific requirements that pertain to research with Indigenous Peoples which are outlined in the TCPS2 in Articles 9.7.

Researchers looking to critique or challenge the policies and practices of institutions, governments, interest groups or corporations, do not need to seek the organization’s permission to proceed with the proposed research. However, individuals who are approached to participate in a research project about their organization need to be fully informed about the views of the organization regarding the research. Researchers also need to inform participants when the permission of the organization has not been obtained.

Researchers engaging in critical inquiry need to state any anticipated or known risks in the information consent letter for any potential participants who may take part in research about their organization. These risks may include:

• stigmatization,
• breach of privacy,
• negative organizational politics,
• reprisals if they speak out against the organization, or
• disclosing information which the organization may view as confidential or proprietary.

In particular, prospective participants need to be fully informed of the possible consequences of participation.

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