Sage Journals: Discover world-class research

Abstract

Researchers seeking to engage in projects related to Tribal communities and their citizens, lands, and non-human relatives are responsible for understanding and abiding by each Tribal nation’s research laws and review processes. Few studies, however, have described the many diverse forms of Tribal research review systems across the United States (US). This study provides one of the most comprehensive examinations of research review processes administered by Tribal Research Review Boards (TRRBs) in the US. Through a systematic analysis, we consider TRRBs’ online presence, online documentation, and themes across documents, for five entity types: Tribal nations and Tribal consortiums, Tribal colleges and universities, Tribal health organizations, Indian Health Services, and other Tribal organizations. Results include an assessment of online presence for 98 potential TRRBs, identification of 118 publicly available online documents, and analysis of 41 themes across four document types: Tribal research codes and TRRBs’ guidelines, applications, and post-approval documents. Altogether, this research provides a macro-level analysis of the most common types of TRRBs in the US in an effort to increase researchers’ understanding of these important processes as they prepare to ethically engage Tribal communities in research. These results aim to empower Tribal decision makers as they align their TRRBs’ online visibility and documentation with community priorities and strengthen their protections for the rights and wellbeing of their citizens and community. Ultimately, by expanding our knowledge of TRRBs across the US, this contribution seeks to uphold Tribal sovereignty in research and promote ethical approaches to research with Indigenous communities.

Keywords

American Indian Alaska Native (AIAN)Indigenous Indigenous research ethics Institutional Review Boards IRBs online presence Tribal Institutional Review Boards Tribal Research Review Boards

Introduction

Protecting Indigenous knowledge systems of Tribal nations and their citizens who participate in research has been a growing effort for Tribes across the United States (US). Similar to previous centuries, Tribes have been exercising their inherent sovereignty to safeguard their community-held cultural rights by drawing on existing protocols and developing internal processes to review and approve research projects involving their citizens (Sahota, 2009; Tsosie, 2007). These contemporary processes have been a response to the colonial violence inflicted through unethical research practices, which has subsequently led to growing mistrust of healthcare professionals, academic researchers, scientists, and outsiders (Hayward et al., 2021; Smith, 2021). Harmful and exploitative practices, such as the exotification of Indigenous peoples in human zoos by early settler-colonialists, land acquisition tactics during the Trail of Tears, and the ongoing exploitation and misappropriation of Tribal culture by sports teams, mining industries, and other groups have been well-documented (Cardon, 2021; Nielsen and Jarratt-Snider, 2020; Putnam, 2012). These dehumanizing actions occur against the backdrop of centuries-old threats by the US to erode Tribal sovereignty and violate Treaty Rights. Despite historical and repeated efforts by the federal government to decimate and overall invisibilize American Indian and Alaska Native (AIAN) populations, it is important to acknowledge that there are currently 574 federally recognized Tribes (US Department of the Interior Indian Affairs, n.d.) and over 400 non-federally recognized Tribes in the US (US Government Accountability Office, 2012).

In order to ensure the ethical conduct of research practices with Tribal citizens, academic researchers must obtain institutional review board (IRB) approval from their primary institutions and, with increasing frequency, from Tribal governments that regulate research in their communities through their own separate research review processes (Kuhn et al., 2020; Tsosie et al., 2021). While researchers are typically familiar with internal human participants divisions, they may be less knowledgeable about external university processes, particularly those involving Tribal entities (Datta, 2018). To address this knowledge gap, this study focuses on Tribal nations, communities, organizations, and institutions that have developed community-level and research approval mechanisms for external researchers. To describe these mechanisms in this study we invoke the term Tribal Research Review Boards (TRRBs) to refer to the many types of review processes created to protect Tribal citizens and communities. It is worth mentioning that Tribal communities across the US are very diverse, consequently so are their research review processes. As such, outside researchers, especially those new to working with Tribes, may face difficulties in locating the necessary research review board documentation to obtain approval and community consent for their research projects. Even so, sidestepping Tribal review and approval processes, unintentionally or otherwise, undermines Tribal sovereignty, laws, codes, and local decision-making authority, while also impeding the opportunity for researchers to advance best practices in Tribally-engaged research (Kuhn et al., 2020; Siddiqui and Sharp, 2021; Tsosie et al., 2021).

Despite the existence of TRRBs since the 1990s (Becenti-Pigman et al., 2008; Morton et al., 2013), and the increasing interest and need for Tribes to lead discussions about research ethics, there is currently no central list that compiles all the diverse forms of TRRBs. Limited studies have contributed to identifying the location, number, or types of TRRBs in the US (Around Him et al., 2019; Kelley et al., 2013; Kuhn et al., 2020; LaFrance and Crazy Bull, 2009). However, having access to this information is essential for Tribal governments to assert sovereignty over research in their communities, and for researchers to adhere to Tribal research codes and regulations enforced by TRRBs (Morton et al., 2013; Sahota, 2009). As Tribal nations continue to form and advance their partnerships and collaborations with researchers, it is becoming imperative that research processes apply methodologies and methods that center Tribal principles and values (Kuhn et al., 2020; Simonds and Christopher, 2013; Tsosie et al., 2021). Ideally, such sustained efforts would also align with Tribal communities’ needs and priorities, include collaborative research ideation, research question formulation, and research design, and conclude with meaningful dissemination of findings within the Tribal community (e.g. see Hiratsuka et al., 2017). Other critically important considerations include Indigenous data sovereignty and Indigenous data governance which, in the context of ethical research, ensures that research data is collected, managed, and owned by Tribes for the benefit of their communities, both now and in the future (Carroll et al., 2019; Hudson et al., 2023; Kukutai and Taylor, 2016).

Our study focuses on how Tribes and representative groups are establishing research review processes across the US and incorporating TRRBs into their governance structures to guide research in their communities. Thus, to gather a comprehensive dataset of potential TRRBs, we began by compiling a list of Tribal communities’ active and deactivated registrations in the US Department of Health and Human Services (USDHHS), Office for Human Research Protections (OHRP) online database (US Department of Health and Human Services, Office for Human Research Protections, n.d.-b). Based on the findings from a previous study, we started with a list of Tribal IRB, Federalwide Assurance (FWA) and IRB Organization (IORG) registrations (Kuhn et al., 2020). We further supplemented this list with TRRBs identified through literature review, professional knowledge, and online searches. This approach recognizes both the advantages and the limitations of using the OHRP database to locate TRRBs, as these registrations are necessary for only specific types of research.

According to the USDHHS OHRP, institutions engaged in non-exempt human participants research conducted or supported by any USDHHS agency must register an FWA with the OHRP. An FWA signifies a commitment to comply with 45 CFR part 46, the code of federal regulations for protecting human participants in research. When obtaining an FWA, it is necessary to identify an IRB registered with OHRP that will provide oversight for the research. Organizations that register one or more IRBs are registered as IORGs. All FWA, IRB and IORG registrations must be renewed to maintain their active status, however, the OHRP database lists both active and deactivated registrations (US Department of Health and Human Services, Office for Human Research Protections, n.d.-a). Because Tribal registrations likely indicate current or past research with Tribal communities, they may also help researchers identify TRRBs that oversee this research. Therefore, we included all active and inactive FWA, IRB, and IORG Tribal registrations in our initial dataset of potential TRRBs. However, as OHRP registrations are limited to specific types of federal funding and human participants research, they may not encompass the full range of research and research review conducted in Tribal communities. Thus, our approach sought to identify both registered and non-registered TRRBs by searching the OHRP database and other sources.

To advance our understanding of the various forms of TRRBs, we examined five entity types that are key in creating a TRRB: Tribal nation or Tribal consortium (TN), Tribal college or university (TCU), Tribal health organization (THO), Indian Health Service (IHS), and other Tribal organization (OTO) (Around Him et al., 2019; Kuhn et al., 2020). As far as we know, there are no other studies that have thoroughly examined the online presence and documentation of Tribal research review boards. Therefore, we specifically sought to identify which TRRBs have an online presence, and then described four main types of online documentation we located using Google searches. Next, derived from our online searches, we examined 118 online TRRB documents and identified themes across document types. Our findings contribute to our understanding of TRRBs, their online presence, and online documentation. They also demonstrate how Tribes and Tribal organizations have shaped their research review processes to safeguard their interests within the research community.

Methods

Nomenclature: In this paper, we established a set of nomenclature to describe our work. The term TRRB, an umbrella term expanded from Tribal institutional review boards, encompasses the various processes that Tribes use to review research applications and oversee research projects. These processes include research review boards, community advisory boards, ethics committees, and other similar terms (Sahota, 2009). We use the term Entity to describe the governing authority of the TRRB and Entity Type to further describe the relationship of that entity to the Tribal community or communities it serves. These terms build upon previously defined categories (Around Him et al., 2019; Kuhn et al., 2020). Additionally, we adhere to the Terminology Style Guide of the Native Center Governance Center (2004), which recommends capitalizing certain words like “Tribe,” “Tribal,” “Native,” “American Indian,” and “Treaty Rights,” regardless of their usage as part of a proper noun. Finally, we intentionally avoid using the term “human subjects” and instead we use the term “human participants.”

Respecting Tribal Communities’ Privacy: In this study, our goal was to conduct a broader thematic analysis of 98 TRRBs, rather than addressing them individually. Therefore, we do not find it necessary to mention specific TRRBs by name in this work. We also recognize that this manuscript is a public medium of dissemination, and we acknowledge the preference of certain Tribal communities served by TRRBs to remain anonymous in publications. This approach maintains research integrity while respecting and upholding Tribal communities’ right to privacy (Kuhn et al., 2020).

Research Questions (RQs) : This study is guided by three overarching topics and related research questions:

• RQ1: Online Presence—Which TRRBs have an online presence?

• RQ2: Online Documentation—What types of TRRB documents are publicly available online?

• RQ3: Themes in Documentation

(a) What themes are present among a dataset of TRRB online documentation?

(b) Which themes are most prevalent among this online documentation?

TRRBs dataset

For this study, we first developed a dataset of TRRBs based upon a previous study’s list of TRRBs with active and deactivated IRB registrations in the OHRP database (Kuhn et al., 2020). We expanded the original list to include all potential TRRBs with active or deactivated IRB Organization (IORG) or Federal Wide Assurance (FWA) registrations, also identified during this previous study. We then added to this list TRRBs identified in the existing literature through an informal review process we refer to as “literature review.” Additionally, we included TRRBs identified through our research team’s professional knowledge and during our online Google searches. Finally, we searched the OHRP database for active and deactivated IRB, IORG and FWA registrations for all TRRBs added to the list based upon the literature review, professional knowledge, and online searches.

RQ1: Online presence

To address our first two research questions, we conducted Google searches to locate each TRRB and its documentation online. We searched for each entity’s name using various keywords such as community advisory boards, institutional review board, IRB, IRB application, research ethics, research review board, Tribal council, Tribal institutional review board, Tribal research code, and Tribes. If our searches returned a new name for the originally searched TRRBs, we also conducted searches for the new name along with these same keywords. Additionally, when applicable, we searched for each TRRB’s FWA, IRB, and IORG registration numbers online. Some online search results returned a website that was not specifically for the TRRB itself, but for related entities such as a Tribal nation or health organization. In these cases, we also utilized search functions within that related entity’s website using the same search terms mentioned earlier. We conducted all online searches between September 2019 to January 2020.

Our findings were recorded and organized in a spreadsheet that included the entity name, entity type, date searched, and website address. Through this process, we identified five types of TRRB entities that are authorized to provide research review for each of the following communities or organizations (Around Him et al., 2019; Kuhn et al., 2020). These entity types are as follows:

Tribal Nation or Tribal Consortium (TN): a Tribal nation is a federally recognized AIAN nation or community in the US, a Tribal consortium is a coalition of two or more Tribal nations.

Tribal College or University (TCU): a Tribally or federally chartered institution of higher education that aims to serve AIAN students while upholding AIAN culture and communities (American Indian Higher Education Consortium and The Institute for Higher Education Policy, 1999; Around Him et al., 2019).

Tribal Health Organization (THO): an organization that primarily provides health services to AIANs that is not included in the IHS category.

Indian Health Services (IHS): “an agency within [HHS that] is responsible for providing federal health services to [AIANs]” (US Department of Health and Human Services, Indian Health Service, n.d.).

Other Tribal Organization (OTO): an organization that primarily serves AIAN populations, that is not included in any other category.

From these search results we assessed each TRRB’s degree of online presence, categorizing them as Present, Mentioned or Absent. TRRBs were considered Present if our online searches led to a website hosted by the TRRB itself or by an office or agency located within the respective Tribe(s) that served as the primary representative of their TRRB’s own content. TRRBs were classified as Mentioned if their content was found on a website hosted by an organization other than the TRRB or Tribe(s) it served, such as health organizations or university websites. In such cases, the external website mentioned a specific TRRB by providing contact information, directing their audience to another website or merely commenting on their existence. If our search yielded no mention of the TRRB online, we categorized their online presence as Absent.

RQ2: Online documentation

During the online searches we collected and arranged digital copies of all documents that were relevant to each TRRB. Through an iterative review process among three research team members, we identified four Document Types as follows:

Tribal research codes (TRCs): laws enacted by Tribal nations that outline the rules and regulations governing research, TRRBs, and research review processes with their communities.

Guidelines (GLs): documents that describe the requirements and processes for research, TRRB administration, and research review.

Research Applications (RAs): application forms that researchers must submit to TRRBs to obtain research approval.

Post-Approval Documents (PAs): documents related to TRRB oversight and management of research projects after they have been approved until their completion.

The categorization of the gathered documents into four types provides a comprehensive framework for understanding and organizing these TRRB documents.

RQ3: Themes in documentation

To address our final research question, we followed a systematic approach that began with developing a codebook. Next, we calculated the appearance and prevalence of each code among four document types, and then calculated the overall prevalence of code among all document types. Additionally, we created a bar chart to aid in visualizing the Appearance of Code data.

Codebook with appearance & prevalence of code

Codebook

First, we developed a codebook to analyze the emergence of codes among different entity types and document types. To create our codebook, we began by iteratively employing thematic analysis for all online documents (Miles et al., 2014). We developed an initial list of 30 codes, based upon the TRRB themes and research application elements identified in a previous study’s content analysis of six TRRBs’ documentation (Kuhn et al., 2020), expanding our understanding of these themes across a larger set of TRRBs and documents. Using ATLAS.ti 9 for Mac, we then deductively coded all documents using these codes, which we refer to as Existing Codes. Then, we conducted an inductive coding process to identify new themes that emerged across this larger set of TRRB documentation and refer to these 11 additional codes as Emerging Codes. To ensure consistency, two members of the research team reviewed and discussed all codes, reaching a consensus and finalizing the codebook.

Appearance & prevalence of code by document type

Next, we calculated the Appearance of Code (a_n) and the estimated Prevalence of Code (Y_n). We categorized all documents into the four document types and Entities with Documents (e). We then determined the appearance of code by counting the number of entities that had at least one document of a document type containing that code. To calculate the Overall Appearance of Code, we summed up the appearance of code totals across all document types for each code.

To estimate the Prevalence of Code for each document type, we divided the appearance of code (a) by entities with documents (e) and reported this number as a percentage. This process is reflected in the following formula:

Estimated prevalence of code for each document type

$Y_{n} = \frac{a_{n}}{e_{n}}$

$Y_{n} = e s t i m a t e d p r e v a l e n c e o f c o d e a m o n g e n t i t i e s w i t h d o c u m e n t s o f t h i s t y p e$

$a_{n} = a p p e a r a n c e o f c o d e (# o f e n t i t i e s w i t h \geq 1 d o c u m e n t o f t h i s t y p e c o n t a i n i n g t h i s c o d e)$

$e_{n} = e n t i t i e s w i t h d o c u m e n t s (# e n t i t i e s w i t h \geq 1 d o c u m e n t o f t h i s t y p e)$

Overall prevalence of code

We calculated the estimated Overall Prevalence of Code for all four document types. To do this, for all four document types, we first determined the sum of appearance of code (a). Then, we divided this total by the sum of entities with documents (e). We reported the estimated overall prevalence ( X_overall) of code for all document types as a percentage. This process is reflected in the following formula:

Estimated overall prevalence of code for all document types

$X_{o v e r a l l} = \frac{a_{1} + a_{2} + a_{3} + a_{4} + \dots}{e_{1} + e_{2} + e_{3} + e_{4} + \dots}$

$X_{o v e r a l l} = e s t i m a t e d o v e r a l l p r e v a l e n c e o f c o d e a m o n g e n t i t i e s w i t h d o c u m e n t s o f a l l t y p e s$

We organized and presented all codes according to their highest to lowest overall prevalence of code. Finally, we identified the top five codes with the highest overall prevalence for further consideration.

Visualizing appearance of code

To gain a better understanding of the prominence of each code across all documents, and the distribution of each code among each document type, we created a bar chart. This chart visualizes each code as a bar, ordered from highest to lowest overall appearance of code. Each bar is divided into four segments, representing its appearance of code for each document type.

Results

TRRBs dataset—Table 1

We began with a TRRB dataset from a previous study that consisted of 48 IRB registrations in the OHRP database, including active (31) and deactivated (17) registrations (Kuhn et al., 2020). From this previous study’s findings, we also added 22 potential TRRBs with IORG or FWA registrations, including active (10), deactivated (7), or a combination of active and deactivated (5) registrations. Altogether, we created an initial list of 70 potential TRRBs based on this prior work.

We added 28 TRRBs that were identified through literature review (Around Him et al., 2019; Tom, 2015), our research team’s professional knowledge, and via online searches. Among these 28 additional entities, 8 had OHRP registrations and 20 did not. Altogether, our study included 98 potential TRRBs, out of which 78 had OHRP registrations and 20 did not (Table 1).

Table 1.

TRRBs dataset. US Tribal Research Review Boards included in dataset.

Source of TRRBs	Description	Registered in OHRP		Not registered in OHRP		Total
Source of TRRBs	Description	Subtotal	Total	Subtotal	Total	Total
Previous study	TIRBs with OHRP registrations		70		0	70
Current study additions	Literature review	1		5
	Professional knowledge	3		15
	Online searches	4		0
	Total additions		8		20	28
Total all sources			78		20	98

TRRBs: Tribal Research Review Boards; OHRP: US Department of Health and Human Services Office for Human Research Protections (OHRP) online database. Previous Study: Kuhn et al. (2020). TIRBs: Tribal Institutional Review Boards.

RQ1: Online Presence—Table 2

Table 2 presents the results of online searches for 98 TRRBs across various entity types. Out of these, there were 51 Tribal Nations or Tribal Consortiums (TNs), 21 Tribal Colleges or Universities (TCUs), 10 Tribal Health Organizations (THOs), 14 Indian Health Services (IHSs) and 2 Other Tribal Organizations (OTOs). Overall, our online searches showed that 40 (41%) of all TRRBs were present, 24 (24%) were mentioned, and 34 (35%) were absent (Table 2a) (present, mentioned, absent are defined in Methods section B). Entity types with the highest percentage of TRRBs found to be present were TCUs (16 of 21, 76%) and IHSs (10 of 14, 71%). TNs were the most common entity type found to have TRRBs that were mentioned by an external organization (19 of 51, 37%). THO and OTO TRRBs were most often absent (5 of 10 and 1 of 2 respectively, both 50%), followed closely by TNs (22 of 51, 43%).

Table 2.

Online presence. Online presence of 98 US Tribal Research Review Boards, registered & not registered in OHRP, by entity type and by source.

Category (n)	Present		Mentioned		Absent
Category (n)	Total	% of Category	Total	% of Category	Total	% of category
(a) Entity type—TRRBs registered & not registered in OHRP
TN (51)	10	20	19	37	22	43
TCU (21)	16	76	2	10	3	14
THO (10)	4	40	1	10	5	50
IHS (14)	10	71	1	7	3	21
OTO (2)	0	0	1	50	1	50
Total All Types (98)	40	41	24	24	34	35
(b) Source—TRRBs registered in OHRP
Previous study (70)	32	46	13	19	25	36
Literature review (1)	0	0	1	100	0	0
Professional knowledge (3)	1	33	1	33	1	33
Online searches (4)	0	0	1	25	3	75
Total registered (78)	33	42	16	21	29	37
(c) Source—TRRBs not registered in OHRP
Previous study (0)	0	0	0	0	0	0
Literature review (5)	3	60	2	40	0	0
Professional knowledge (15)	4	27	6	40	5	33
Online searches (0)	0	0	0	0	0	0
Total not registered (20)	7	35	8	40	5	25

TRRBs: Tribal Research Review Boards; OHRP: US Department of Health and Human Services Office for Human Research Protections (OHRP) online database. Entity Type: TN: Tribal Nation or Tribal Consortium; TCU: Tribal College or University; THO: Tribal Health Organization; IHS: Indian Health Service; OTO: Other Tribal Organization. Previous Study = Kuhn et al. (2020).

Results also illustrate differences among the online presence of TRRBs registered or not registered in the OHRP database. Of the 78 TRRBs registered in the OHRP, 49 (63%) were either present or mentioned online (Table 2b). Of the 20 TRRBs that were not registered in the OHRP, 15 (75%) were either present or mentioned online (Table 2c). Conversely, of the 40 TRRBs that were found to be present online, 33 (83%) were registered and 7 (18%) were not registered in the OHRP. Of the 24 TRRBS that were mentioned, 16 (67%) were registered and 8 (33%) were not.

Online presence was mixed for the 28 TRRBs added to our dataset based on literature review, professional knowledge, or online searches. Overall, 8 (29%) were present, 11 (39%) were mentioned, and 9 (32%) were absent, with the majority (19, or 68%) found to be present or mentioned.

RQ2: Online Documentation—Table 3

We were able to find online documentation for 37% of the 98 TRRBs listed in Table 1, yielding a total of 118 publicly accessible TRRB documents (Table 3a). The distribution of entity types with online documentation counts was, from greatest to least, TNs (18), TCUs (13), THOs (3), IHSs (2), and OTOs (0). Based on our dataset, we found the highest percentage of online documentation for TCUs (62%), followed by THOs (60%), TNs (35%), IHSs (14%), and OTOs (0%). Total documents found per document type were: 13 Tribal Research Codes (TRCs), 43 Guidelines (GLs), 41 Research Applications (RAs), and 21 Post-Approval Documents (PAs) (Table 3a). TNs had the most TRCs (11) and GLs (26), while TCUs had the highest count of RAs (23) and PAs (11).

Table 3.

Online documentation. Online documentation of 98 US Tribal Research Review Boards by document type and entity.

Entity type (n)	# Entities with online documentation (% of n)	Document type				Total
Entity type (n)	# Entities with online documentation (% of n)	TRC	GL	RA	PA	Total
(a) Documents by entity type
TN (51)	18 (35%)	11	26	12	6	55
TCU (21)	13 (62%)	1	11	23	11	46
THO (5)	3 (60%)	1	5	4	2	12
IHS (14)	2 (14%)	0	1	2	2	5
OTO (2)	0	0	0	0	0	0
Total (98)	36 (37%)	13	43	41	21	118
(b) Entities with documents
TN (51)	18 (35%)	11 (61%)	12 (67%)	9 (50%)	3 (17%)	n/a
TCU (21)	13 (62%)	1 (8%)	10 (77%)	13 (100%)	6 (46%)	n/a
THO (5)	3 (60%)	1 (33%)	3 (100%)	3 (100%)	2 (67%)	n/a
IHS (14)	2 (14%)	0	1 (50%)	1 (50%)	1 (50%)	n/a
OTO (2)	0	0	0	0	0	n/a
Total (98)	36 (37%)	13 (36%)	26 (72%)	26 (72%)	12 (33%)	n/a

Document type: TRC: Tribal research code; GL: guideline; RA: research application; PA: post-approval document. Entity type: TN: Tribal Nation or Tribal Consortium; TCU: Tribal College or University; THO: Tribal Health Organization; IHS: Indian Health Service; OTO: Other Tribal Organization.

Since many entities had multiple documents of each document type, we identified the number of entities that had at least one document of each document type, which we named entities with documents (Table 3b). This allowed us to determine how common each document type was among the entities with online documentation. For example, Table 3a shows that, of the 51 TRRBs in our dataset of the TNs type, we found online documentation for 18 of them, which included 26 GLs. However, further analysis in Table 3b, revealed that only 12 of these 18 (67%) TNs created at least one of these 26 GLs, which also means that 6 of the TNs TRRBs with online documentation did not create any GLs.

Of the entities with documents (Table 3b), we see the two highest percentages of document types per entity type as follows: TNs: GLs (67%), TRCs (61%); TCUs: RA (100%), GLs (77%); THOs: GLs and RAs (both 100%); IHSs: GLs, RAs, and PAs (all 50%). Overall, among all of these entity types, 72% had GLs and RAs, 36% had TRCs, and 33% had PAs.

RQ3: Themes in documentation—Table 4, Figure 1

Codebook, appearance & prevalence of codes—Table 4

Codebook

Our analysis resulted in a final codebook comprising 41 codes. This includes 30 codes from a previous study that we used for deductive coding analysis (existing codes), and 11 codes that emerged during our inductive coding process (emerging codes) (Table 4). For each code, we calculated its prevalence for each document type, as well as its overall prevalence across all document types. We then presented all codes in descending order from highest to the lowest overall prevalence.

Table 4.

Codebook, prevalence of code & appearance of code. Code’s name, description, prevalence of code (%) and appearance of code, for each and all document types.

Code name & description	Prevalence of code % & appearance of code by document type				Overall prevalence & appearance
	TRC (n = 13)	GL (n = 26)	RA (n = 26)	PA (n = 12)	All types (n = 77)
Risks: Identification of potential and actual risks of the study, plans to manage risks, adverse event handling.	77% (10)	65% (17)	92% (24)	67% (8)	77% (59)
Data management: Management of data collected and produced from the study (e.g. record keeping requirements, privacy and confidentiality).	69% (9)	77% (20)	85% (22)	67% (8)	77% (59)
Benefits: Identification of potential and actual benefits of the study, plans to increase benefits.	69% (9)	73% (19)	92% (24)	42% (5)	74% (57)
Informed consent & assent: Informed consent and assent history, definitions, requirements, policies, procedures and forms.	62% (8)	73% (19)	85% (22)	50% (6)	71% (55)
Findings & dissemination: Findings of the study (e.g. preliminary and final) and dissemination of data and findings collected and produced from the study.	100% (13)	62% (16)	62% (16)	75% (9)	70% (54)
Research team description: Information about the research team members, their roles, biographical information, curricula vitae (CVs) and contact information.	46% (6)	46% (12)	96% (25)	83% (10)	69% (53)
Research overview: Project abstract, description, protocol, study site(s), data abstraction plans, related findings.	69% (9)	54% (14)	96% (25)	33% (4)	68% (52)
Application elements & formats: Documents and other items that must be submitted with the research application and acceptable submission formats.	85% (11)	62% (16)	62% (16)	50% (6)	64% (49)
Progress: Progress made in the study (e.g. preliminary results, activities completed, status updates and renewals).	77% (10)	58% (15)	50% (13)	75% (9)	61% (47)
Changes to the study: Changes made to the study (e.g. changes to the protocol, recruitment, participants, consent, risks, benefits, staff).	62% (8)	62% (16)	54% (14)	75% (9)	61% (47)
Budget & funding: Budgets and funding source details for the research project (estimated, actual, and changes).	69% (9)	27% (7)	85% (22)	67% (8)	60% (46)
Recruitment & participants: Recruitment methods and materials, sample size, study population, participants’ characteristics and relationship to researchers, inclusion/exclusion criteria and withdrawal of study participants.	23% (3)	54% (14)	77% (20)	67% (8)	58% (45)
Approvals & support: Approval and/or support from the Tribal community or other review boards.	23% (3)	65% (17)	81% (21)	33% (4)	58%(45)
*Timeline: The research study schedule outlining the estimated and actual start and end dates and study duration.	62% (8)	23% (6)	81% (21)	58% (7)	55% (42)
Application review stages & steps: An overview of single actions and/or sets of actions taken during the application review and appeals process.	69% (9)	77% (20)	35% (9)	33% (4)	55% (42)
Jurisdiction: The type of research that the board oversees (e.g. health research, human participants research).	85% (11)	77% (20)	19% (5)	0	47% (36)
Certification & agreements: Researchers’ declarations related to application contents and confirmation of understanding and agreement to follow policies and procedures.	29% (4)	27% (7)	77% (20)	42% (5)	47% (36)
*Closure: The processes that take place at the end of a study (e.g. suspensions, terminations, procedures, and reporting requirements).	71% (10)	42% (11)	31% (8)	50% (6)	45% (35)
Instruments: Tests, instruments, measures and recording devices used in the study (e.g. surveys, questionnaires, audio/video recordings).	14% (2)	46% (12)	65% (17)	25% (3)	44% (34)
Governing authority: The source of authority for the organization that is administering the review board and overseeing research review (e.g. Tribal nation’s research code).	79% (11)	58% (15)	19% (5)	8% (1)	42% (32)
*Types of review: Description and process for different types of research review (e.g. exempt, expedited, regular / full).	14% (2)	50% (13)	54% (14)	17% (2)	40% (31)
Researchers’ responsibilities: The obligations of the research team during the application and research process.	21% (3)	31% (8)	50% (13)	42% (5)	38% (29)
Biological samples: The handling, storage, disposal and return of any physical samples obtained from study participants.	57% (8)	31% (8)	46% (12)	0	36% (28)
Board administration: The administration and responsibilities of the review board and its members (including responsibilities for specific positions such as the board Chair).	86% (12)	54% (14)	4% (1)	0	35% (27)
*Compensation to participants: Payments or other benefits provided to the study participants.	14% (2)	27% (7)	69% (18)	0	35% (27)
Research team training: Additional actions that the research team must complete before or during the study to increase their knowledge or skills.	23% (3)	31% (8)	50% (13)	25% (3)	35% (27)
*Researchers’ additional interests: Concerns or goals of the researcher(s) beyond regular research findings (e.g. financial, commercialization, conflicts of interest).	62% (8)	23% (6)	42% (11)	8% (1)	34% (26)
*Vulnerable participants: The definition, inclusion and treatment of research participants deemed vulnerable.	23% (3)	35% (9)	54% (14)	0	34% (26)
Populations served: The specific group or community and geographical area that the review board was created to serve.	92% (12)	50% (13)	0	0	32% (25)
*Community involvement: The involvement of Tribal community members in the study.	46% (6)	35% (9)	31% (8)	8% (1)	31% (24)
Guiding principles: The mission statement, vision, and values that guide the review board and its research review process.	77% (10)	46% (12)	4% (1)	0	30% (23)
Data ownership: Ownership of the data collected and produced from the study (including intellectual property).	77% (10)	31% (8)	8% (2)	0	26% (20)
Board membership: The appointment of members to the review board and its member composition.	62% (8)	42% (11)	0	0	25% (19)
Cultural considerations: Emphasis placed on the cultural significance and/or on the importance of protecting certain cultural elements in the context of research.	31% (4)	31% (8)	23% (6)	8% (1)	25% (19)
Fees & compensation: Payments or other benefits provided to the review board and/or Tribal community.	77% (10)	15% (4)	19% (5)	0	25% (19)
*Definitions for research: Descriptions of meaning for terms related to research and Tribal communities (e.g. “Research,” “Human Subjects,” “Reservation”).	54% (7)	35% (9)	0	8% (1)	22% (17)
*Enforcement: Implementation of Tribal research codes and guidelines to regulate research activities (e.g. penalties for unlawful research and misconduct).	77% (10)	15% (4)	8% (2)	0	21% (16)
Compliance & ethics: Adherence to required ethics training for Collaborative Institutional Training Initiative (CITI) and Health Insurance Portability and Accountability Act (HIPAA).	8% (1)	19% (5)	27% (7)	17% (2)	19% (15)
*History of research: Description of past research events specific to Tribal communities and peoples.	31% (4)	38% (10)	4% (1)	0	19% (15)
*Deception of participants: The intentional misleading or withholding of information from participants in a study (description of plans, justification, risk, debriefing).	0	15% (4)	35% (9)	0	17% (13)
Drugs or substances: The use of chemical or other substances in the study.	0	23% (6)	23% (6)	0	16% (12)

Document type: TRC: Tribal research code; GL: guideline; RA: research application; PA: post approval document.

Emerging codes.

Appearance & prevalence of code by document type

For each document type, we also identified the three codes with the highest overall prevalence. For TRCs, it was Findings & dissemination (93%) followed by Populations served and Board administration (both 86%). For GLs, it was Jurisdiction, Application review stages & steps, and Data management (all 77%). Among RAs, the most prevalent codes were Research team description, and Research overview (both 96%), followed by Risks and Benefits (both 92%). Lastly, among PAs, Research team description was the most prevalent (83%) followed by Changes to the study, Progress, and Findings & dissemination (all 75%). Additionally, seven codes were found to have a prevalence of 50% or higher across all document types: Risks, Data management, Informed consent & assent, Findings & dissemination, Application elements & formats, Progress, and Changes to the study. The Benefits code also came very close to a prevalence of 50% or higher across all document types, except for PAs with a prevalence of 42%.

The prevalence of all 41 codes across the four document types resulted in a total of 164 calculations of prevalence. Within these calculations, 65 (40%) resulted in a code having a prevalence over 50% in one document type, while 18 (11%) showed a code with 0% prevalence in one document type.

Overall prevalence of code

The five codes with the highest overall prevalence among all document types (Table 4) are all existing codes: Risks (76%), Data management (76%), Benefits (73%), Informed consent & assent (71%) and Findings & dissemination (69%). Risks and Data management both have the highest estimated prevalence for all document types (76%), as well as high estimated prevalence for each document type (prevalence for Risks ranges from 65% to 92%; prevalence for Data management ranges from 64% to 85%).

Emerging codes (denoted with an asterisk in Table 4) ranked in order of overall prevalence from greatest to least are: Timeline (55%), Closure (45%), Types of review (40%), Compensation to participants (35%), Researchers’ additional interests (34%), Vulnerable participants (34%), Community involvement (31%), Definitions for research (22%), Enforcement (21%), History of research (19%), and Deception of participants (17%).

Visualizing appearance of code—Figure 1

Based on our data, it becomes visually evident that codes with the highest total appearance of code (bars located at the top of Figure 1) are more equally distributed across document types, with a slight preference for appearing in GLs and RAs. In fact, there is an overall trend toward codes appearing in GLs and RAs, while fewer codes are observed in PAs. We can identify a few codes that appear more often in TRCs and GLs, than in RAs and PAs, such as Jurisdiction, Governing authority, Board administration, Populations served, Guiding principles, Data ownership, Board membership, Fees & compensation, Definitions for research, and Enforcement.

Figure 1.

Appearance of code. Appearance of code, for each code, among four document types, ordered from greatest to least overall appearance of code among all document types.

Discussion

This study aims to support ethical research with Tribal communities by providing clarity on the process of locating TRRBs online, understanding their online presence and the types of documents they provide online, and identifying overarching themes among their documentation. When researchers seek approval to conduct research with Tribal communities, it is both a legal and ethical responsibility to respect Tribal sovereignty (Carroll et al., 2022a; Tsosie et al., 2021). This commitment includes adherence to TRRB processes, which regulate research activity among Tribal citizens and within Tribal territories. However, TRRBs in the US are highly diverse, serving many different Tribal communities. Our research suggests that using the OHRP registrations can be an effective initial step in locating TRRBs. However, additional searches beyond mainstream IRBs are necessary to locate TRRBs, as OHRP primarily focuses on federally funded human participants research. Researchers must therefore employ an array of search strategies to ensure they locate and adhere to all TRRB guidelines and Tribal research codes prior to conducting research involving Tribal communities and their territories.

Additionally, TRRBs and Tribal communities may both be able to assist researchers with locating and engaging with the correct TRRBs. We recommend TRRBs clearly identify on their website and/or in their documentation, such as GLs and RAs: (1) the names of the Tribal communities they serve, and (2) the specific types of research they review for each community. Although some TRRBs in our study shared this information, it did not appear to be explicitly provided by all. We understand that TRRBs must respect the privacy and goals of each Tribal community they serve; therefore, it may not always be possible to publicly share this information online. We also encourage Tribal communities to provide a central list on their website, if possible, that includes the following information: (1) names and contact details of each research review entity for their community, (2) the type of research they review, and (3) contact details for a Tribal representative who can help researchers locate the appropriate TRRB for their work. Although we did not systematically account for this information during our online searches, it appeared that few TNs clearly provided this detailed information on their websites. This may reflect that some TNs do not have active websites or other online presence or they choose not to disclose this information publicly. Also, we have observed that each community may utilize a variety of research review processes, so gathering and maintaining all this information online may require significant time and resources, particularly for communities engaging in many types of research. These costs are in addition to the already considerable costs associated with administering research review processes such as IRBs (Speckman et al., 2007). Although some TRRBs charge fees for research permits or licenses (Carroll et al., 2022b), more research is needed to understand the various costs associated with different forms of TRRBs and how these costs are managed and distributed among those engaging with and benefiting from Tribal research.

Ensuring research is conducted ethically in Indigenous communities will require a concerted effort involving TRRBs and Tribal communities, who may be able to provide current, accessible information on their research review processes, and researchers, who must commit the time and resources necessary to fully comply with these requirements. A more streamlined process of connecting researchers with the information and instructions they need, will ultimately facilitate improved engagement on research goals. To achieve this respectfully and responsibly, efforts must uphold Tribal sovereignty and support the research goals and privacy of Tribal communities. Additionally, the equitable distribution of cost and responsibilities for establishing and maintaining these information systems should be considered among researchers, institutions and communities.

TRRBs dataset

In this study, we developed our approach for locating TRRBs within OHRP’s database and through literature reviews, professional knowledge, and online searches. The OHRP database is a productive starting place for this type of inquiry as it provides information on review boards and institutions involved in human participants research, including registered IORGs, registered IRBs, and approved FWAs. Initially, we started with a list of 70 potential TRRBs based on the findings from a previous study, including active and deactivated registrations for IRBs (48) and IORGs and/or FWAs (22) (Kuhn et al., 2020). This study further develops the process of identifying TRRBs through OHRP registrations, expanding it beyond IRB registrations to consider IORG and FWA registrations as they are also indicators of research activity that may be relevant to Tribal research review. This study additionally included 28 entities in its TRRB dataset based on findings from literature review, professional knowledge, and online searches. This recognition acknowledges the involvement of Tribal communities across the US in various forms of research and research review, some of which do not require OHRP registration. It is important to note that only researchers conducting studies involving human participants in the US are required to register their research review process with the OHRP if their institution receives federal funding or voluntarily adheres to OHRP regulations. However, not all studies fall under federal funding or federal regulations. Additionally, by searching the OHRP database using specific names added to the dataset based on these additional sources, we identified eight more TRRBs that had OHRP registrations, which were not discovered through previous keyword searches. This suggests that there may be more TRRBs with OHRP registrations that were not identified using previous search parameters. We expect that by employing additional search methods, we will be able to identify a broader range of TRRBs, both with and without OHRP registrations.

RQ1: Online presence

The online presence of different types of entities that administer TRRBs can help identify which TRRBs are more active and publicly sharing information online. Our data suggests that TCU and IHS TRRBs have a stronger online presence compared to other types of entities. This may be because of their larger regional status and their involvement in academic and health research. Additionally, they may already have an established online presence for their organization. However, while there were more TNs mentioned online among the TRRBs, an even larger number of TNs were categorized as being absent. This indicates that TNs’ TRRBs often do not have their own online presence and are typically mentioned on other organizations’ websites. In informal discussions with Tribal leaders, we learned that there are various reasons why TRRBs may not have an online presence. Some TRRBs may lack the resources to establish and maintain a website and respond to the volume of research inquiries (Gaston Anderson, 2003). Despite these limitations, they may still want to strengthen their online presence to ensure that their research codes and protocols are respected. Striking a balance may be necessary for these TRRBs. They need to be public enough to establish a visible research review process that works to enhance the benefits and reduce the harms of research within their communities, while remaining private enough to avoid being overwhelmed by the number of research requests. Furthermore, in Tribal communities, ethical research relies on relationality, relationship-building, trust, and accountability (Hiratsuka et al., 2017; Wilson, 2008). Therefore, some Tribes may prefer to work with fewer researchers who understand and are willing to engage in long-term relationship building with their community, rather than attracting numerous researchers who are not prepared to conduct research this way.

Determining the online presence of potential TRRBs in our dataset based on their registration status in the OHRP helps us consider if these registrations may be associated with successfully locating active TRRBs. We found that the majority of both TRRBs, registered (63%) and not registered (75%), were present or mentioned online, indicating both types of TRRBs in our dataset are associated with some form of online presence. However, when considering only the TRRBs found to be present online, a large majority were registered (83%), indicating that searching the OHRP database can be an effective method for locating TRRBs with their own online presence. Likewise, a higher percentage of TRRBs mentioned online were registered (67%) compared to those not registered (33%). This further illustrates how OHRP registrations can be useful for identifying potential TRRBs that may not have their own online presence but are recognized as TRRBs by other organizations online.

Finally, the online presence of the TRRBs added to our dataset based on literature review, professional knowledge, or online searches were nearly equally distributed between present (29%), mentioned (39%), and absent (32%). However, the majority (68%) of these TRRBs were found to be present or mentioned, even though most (20 of 28, or 71%) are not registered. This suggests that these sources could be valuable for identifying active TRRBs online that are not part of the OHRP registry. However, further research is needed, including a systematic literature review and a broader survey of professional knowledge on this topic.

RQ2: Online documentation

To gain a deeper understanding of TRRBs, it is important to examine the various types of online documentation available from different entities. First, it helps us describe the complex information landscape encompassing diverse forms of TRRBs and enables us to define useful categories for analyzing TRRB documentation present online. Second, it offers insight into the publicly accessible online TRRB documents, assisting researchers who wish to familiarize themselves with the Tribal review process before submitting research applications, as well as Tribal communities who are in the process of developing their own research review procedures and seeking examples for guidance. For example, among the four document types in our framework, GLs and RAs were the most common document types across entities. This is not surprising, as these documents play a crucial role in administering the research review process and are often made public and accessible to outside researchers seeking approvals (Table 3a). Consequently, researchers engaging in research with Tribal communities would greatly benefit from searching online for both types of documents prior to seeking research approval. We also observed the majority of TNs shared TRCs and GLs online, which aligns with their responsibility in enacting Tribal laws to regulate activity within Tribal communities. TRCs are especially significant for AIAN communities as they provide a legal basis for the exertion of Tribal sovereignty in research (Sahota, 2009) and Tribal laws must be followed by all researchers.

TCUs, which are higher educational institutions that regularly conduct research and oversee student research (Hernandez, 2004), had the highest number of RAs and PAs. Moreover, TCUs not only had the highest online presence but also had the most online documentation compared to other Entity Types. Therefore, researchers may find it useful to consult the readily available online documentation of local TCU TRRBs to find research guidance for Tribal communities in their region. TCUs may also have valuable sample documentation for Tribal communities that are developing their own research review processes, although this documentation may be more tailored to academic research. In contrast, we found relatively few online documents for IHSs, despite their strong online presence. This could be because IHSs, TNs, and THOs work together to administer research review processes (Kelley et al., 2013; Morton et al., 2013), which may affect online search results. Researchers who focus on medical or health research may need to contact their area IHS office directly to determine the entity that administers their TRRB. It is worth noting that the documentation among some TRRBs appeared similar in form, potentially due to the use of similar templates or consultation practices. Lastly, although the documentation fell within the four document types, similar information was often presented across multiple documents of one type, particularly among GLs.

This work is a preliminary step in revealing the types of TRRB documentation available online and which entity types are publicly sharing this information. However, further research is needed to gain a deeper understanding of the content of each document and its relationship to the initial stages of research applications and project closures. By improving our understanding of TRRBs’ online documentation, we aim to support Tribal communities in developing their own research review processes that reflect their priorities and the evolving landscape of Indigenous research ethics. Additionally, we seek to enhance researchers’ knowledge of the diverse Tribal research review processes represented in this documentation.

RQ3: Themes in documentation

Codebook, appearance & prevalence of codes—Table 4

This study is unique in that it is the first to investigate themes across documentation for a large number and variety of TRRBs in the US, building upon datasets and themes developed in a prior study (Kuhn et al., 2020).

Codebook

To analyze the themes found in documentation, we reviewed various existing and emerging codes in our codebook. Through a closer examination of these themes, we can see how TRRBs are redefining research and shaping our understanding of its intended beneficiaries and management. This research is significant because it offers insights into how TRRBs approach the research review process, allowing us to promote and understand their sovereignty and cultural values.

Appearance & prevalence of code by document type

Our data revealed that less than half of all codes across document types had a prevalence over 50%, and certain codes did not emerge at all in specific document types. This variance in prevalence suggests that each document type serves a unique purpose in information sharing and gathering for the TRRB process. Yet, all document types must work together effectively to support the process. For example, TRCs primarily focus on laws and the overall administration of the review process, RAs delve into the details necessary to assess the merits of individual research projects, PAs assist with research oversight post-approval, and GLs cover all aspects of the entire process. Similarly, in our coding process we sought to identify themes across TRRB documentation. During this process, we noticed that certain topics emerged consistently across all document types. However, the emphasis on these topics varied depending on the particular stage of the research process associated with each document type. For instance, TRCs addressed risk with an overall goal of minimizing risk for all research. In GLs and RA risks were discussed in relation to how researchers should identify and assess risks before starting their projects. Conversely, in PAs researchers are required to document how risks were managed during adverse events.

Overall prevalence of code

The five codes with the highest overall prevalence among all document types are all existing codes, reaffirming the themes and application elements identified in a previous study (Kuhn et al., 2020). This also illustrates the importance many Tribal communities have placed on these critical topics throughout their research review processes. For the following discussion, we consider the prevalence of these top codes among each and all document types along with the insights we gained during the coding process that yielded our codebook definitions.

Risks: Tribal communities often prioritize the safeguarding and preservation of their community, cultural knowledge, and citizens (Brockie et al., 2022; Coffey and Tsosie, 2001). This commitment is evident in the high prevalence of the Risks code across all four document types, illustrating TRRBs strong desire to address research risks throughout the research review processes reflected in this documentation. The highest prevalence of Risks was found in RAs, indicating a very high percentage of TRRBs require researchers to address risks before gaining research approval. During our process for developing our codebook definitions, we saw that this code could include identifying and making plans to mitigate potential and actual risks, as well as creating plans for managing risks and handling adverse events. To adequately address a TRRBs concerns about risks, researchers may need to consult a community expert or a relevant governmental office, such as the Tribe’s health center or cultural heritage office, to determine ways to protect both individual participants and the community’s collective rights. The Risks code was next most prevalent in TRCs, indicating that Tribes are addressing research risks in the Tribal laws that govern their research and research review processes. Researchers should be prepared to follow the laws and recommendations established by each community and their TRRBs because they each may uniquely define and establish protocols for protecting participants and their community (Carroll et al., 2022a).

Data management: It is evident from the strong representation of the Data Management code across all document types, particularly RAs and GLs, that TRRBs are consistently addressing data management practices with researchers from the very start of the research review process. This could include record keeping requirements and protocols for maintaining privacy and confidentiality of records. It may also include requirements that researchers provide meaningful data access and data-sharing with Tribal leaders to empower and involve them in decision-making processes and this sometimes takes the form of data-sharing agreements (Harding et al., 2012; James et al., 2014). Through this work, TRRBs are advancing data sovereignty through research oversight that extends beyond what is normally provided through institutional IRBs (Marley, 2019).

Benefits: Similar to Risks, TRRBs prioritize benefits to participants and the community throughout the research documentation. The highest prevalence of this code is found in RAs, when researchers may be required to identify potential and actual benefits of the study, along with their plans to increase benefits. These results echo those of Carroll et al. (2022b), whose analysis of TRCs demonstrates how they work to ensure that research provides collective benefits, shares authority, and demonstrates responsibility to the community.

Informed consent & assent: Informed consent is a crucial ongoing process that ensures prospective participants are fully informed about the research and can freely decide whether to participate. In a Tribal context, informed consent may necessitate obtaining consent from individuals and Tribal governments (Harding et al., 2012; Sahota, 2009). This code most often appears in RAs and GLs, representing a strong effort by TRRBs to share the history, definitions, and requirements for informed consent, while also ensuring researchers provide appropriate informed consent protocols and forms before gaining research approval.

Findings & dissemination : The prevalence of the Findings & dissemination code was 100% for TRCs, indicating that Tribal communities are consistently concerned with how the results of research are handled and shared, regularly addressing this topic in their Tribal laws. We also found that this code strongly emerged in PAs, showing how TRRBs are including this topic in documentation and forms that are utilized after research is approved and before a project is closed. This code includes requirements related to both preliminary and final findings of the study and dissemination of results within and outside the Tribal community. This strongly aligns with other research results showing Tribal communities expect researchers to disseminate findings in ways that uphold “community values, interests and priorities” (Carroll et al., 2022a).

Visualizing appearance of code—Figure 1

From our analysis we gained insights into the appearance of codes across different document types (Figure 1). Codes with the highest overall appearance are likely to be equally distributed among document types because they are important across all stages of the research process. These codes may appear most often in GLs and RAs due to the length and comprehensive text of these documents. Certain codes appear more often in TRCs and GLs, but less so in RAs and PAs. This is likely because they relate to the administration of the TRRB rather than the oversight of specific research projects. These codes include Jurisdiction, Governing Authority, Board Administration, Populations Served, Board Membership, Fees & Compensation, and Enforcement. This same trend among these other codes, however, may provide some important insights to future development of TRRBs: Guiding Principles, Data Ownership, and Definitions for Research. For these codes, this trend possibly indicates that TRRBs are identifying the importance of these topics in their laws and guidance documents, however, subsequent inclusion in their documents relating to oversight of specific research projects is less apparent. These are all important topics for TRRBs to provide guidance on in relation to all potential research and they are also important to address on RAs and PAs, when specific research projects are planned, implemented, and completed. Notably, Data Management, another code similar to Data Ownership, appeared most often in GLs and RAs, illustrating the guidance provided by TRRBs during the planning and application process. However, it appears less often in PAs, after projects are implemented and completed. Based on these insights, we highly recommend that TRRBs ensure they define their requirements and goals for research not only in their laws and guidelines, but also throughout the documentation for individual research projects, specifically in their research applications and post approval documents.

Limitations

This study advances our understanding of TRRBs. However, we recognize the diversity among Tribal communities in the US, which leads to variations in the research review processes they establish to regulate the research conducted with their citizens and on their lands. Initially our focus was on TRRBs with OHRP registrations, but in this work, we expanded our scope by including TRRBs found through literature review, professional knowledge and online searches. Nonetheless, we are aware from our professional knowledge that there are many other types of Tribally-based research review processes that need to be considered in future work. Some of these processes may be less public, such as Tribal council reviews and ad hoc Tribal committees (Nason, 1996). Moreover, TRRBs may also pertain to non-federally recognized Tribal communities, organizations, inter-Tribal populations such as urban AIANs (Haozous et al., 2021; James et al., 2018; Yuan et al., 2014), and even other types of Tribally focused research not typically associated with research review boards. Examples of such research include studies on archives, museums, education, and the environment (Quigley, 2006). As our knowledge deepens, we expect to find more of these less public Tribal community review processes, such as Tribal council or ad hoc committee reviews, thus expanding our list of TRRBs. In anticipation of this expansion, we allocate space in our TRRB framework for other Tribal organizations (OTOs) to represent the diversity of TRRBs related to non-federally recognized Tribal communities and other categories of research.

Additionally, it is apparent that certain TRRB entities may conduct research reviews on behalf of other entity types. For example, a TN’s TRRB may perform research reviews for both its community and an IHS office (Around Him et al., 2019). Alternatively, a TN may delegate the responsibility for research oversight to another Entity Type (Kelley et al., 2013). We are aware that the complexity of research review relationships is not fully captured by our study’s single categorization of Entity Type. Further complexity arises when multiple TRRBs oversee different types of research within one Tribal community, such as health, culture, education, or environmental research (Around Him et al., 2019). Thus, additional work is required to comprehensively describe complex research review systems that involve multiple TRRBs overseeing different forms of research in one or more communities.

We acknowledge that our TRRB dataset and the online documentation cannot fully reflect the “complex realities of Indigenous peoples” (Duarte et al., 2020) nor their diverse Tribal research review processes. As a result, this study aims to enhance our understanding of TRRBs across the US, recognizing the need for future research. To accomplish this, it is necessary to identify additional forms of TRRBs and to engage in direct discussions with them to deepen and expand our understanding of their processes and goals beyond what can be understood from online documentation.

Conclusion

This work aims to clarify the various TRRB processes implemented by Tribal communities and the organizations that serve them as they strive to protect their communities and increase the benefits of research among their citizens and communities. There is much diversity among TRRBs, their online presence and their publicly available online documentation. With this work, we seek to support Tribal sovereignty and support communities in developing and refining their own research review processes. We also aim to enable researchers to engage in ethical and respectful research with AIAN communities by gaining a deeper understanding of the diverse TRRB processes in the US. This involves recognizing both their similarities and differences among these processes and appreciating their uniqueness, while discerning how they expand research review beyond mainstream IRB processes. Our work provides information that is essential for understanding and undertaking ethical research with AIAN communities. Furthermore, we have made efforts to continue expanding our understanding on effectively locating and including more diverse forms of TRRBs and their public documentation in our studies. Through all of the Tribal research codes, guidelines, research applications, and research management documents we have viewed, we have consistently observed TRRBs working to ensure research conducted within their communities respects, supports, and protects diverse AIAN cultures, values, protocols and goals. Going forward, our future work will entail carrying out an in-depth content analysis of these 118 documents to further elucidate how TRRBs are addressing each of the themes identified across all their documentation. With every step, we are excited to learn more about the strength and resilience of AIAN communities as they exercise their sovereignty in research and ensure it increasingly benefits their citizens, communities, and cultures, now and for many generations to come.

Ethical considerations

We recognize some of the concerns regarding ethics statements in AIAN research by providing additional information on our positionality and approach to conducting ethical AIAN research (Gribble and Around Him, 2014). The authors declare that research ethics approval was not required for this study. Nonetheless, as Indigenous researchers, we have critically considered and reflected on the potential risks and benefits of our work to AIAN communities at each research step. We have also taken into account the history of extractive research practices within our communities, and thus, prioritize research goals that address the information and research needs of our communities. Furthermore, it is significant to confirm that all authors of this work are Indigenous scholars. Among them are two enrolled members of different AIAN Tribes in the US and two citizens of a First Nations Band in Canada. This Indigenous authorship not only helps address the historical erasure and lack of representation of Indigenous voices, but also amplifies the voices and experiences of Indigenous communities. The authors bring forth sincere and grounded perspectives informed by and rooted in generations of data, information, knowledge, and wisdom. Through this emphasis on Indigenous authorship, we encourage colleagues to reflect on the broader significance of this trend and the work that is still needed to uphold the voices of Indigenous peoples and their communities. Additionally, we have informally engaged with two Tribal nations to share our research findings, and to learn from their community experiences as they develop and revise their own TRRB processes. This engagement has informed our work and influenced our approach to prioritizing the dissemination of research results that address the information needs of Tribal communities. Furthermore, we determined that identifying Tribal communities by name is not essential for this study. Our main objective is to provide a comprehensive analysis of themes across numerous TRRBs’ documentation. Therefore, we have made a deliberate decision to exclude Tribal community names in this public form of dissemination in order to respect the privacy of these TRRBs and the communities they serve. Our intention is to ensure that our research benefits Indigenous communities, while also minimizing any potential risks and maintaining positive and sustainable relationships. The authors declare no competing interests.

Footnotes

The University of Washington and the authors of this work acknowledge the Coast Salish peoples of this land,the land which touches the shared waters of all Tribes and bands including the Muckleshoot,Snoqualmie,Suquamish,Swinomish,and Tulalip nations. We acknowledge the generosity of the two Tribal nations who invited us to speak with them about our work during their own processes of establishing and revising TRRBs in their communities. This community engagement significantly informed our own process of ensuring our work benefits Indigenous communities. Further,we acknowledge the Tribal communities who have shared information about their TRRBs online as this has provided us with an opportunity to learn more about the diverse,impactful ways communities across the US are creating their own research oversight processes that reduce risks and increase benefits to our communities. We hope this work supports additional Tribal communities as they develop and update their own TRRBs.

Funding

All articles in Research Ethics are published as open access. There are no submission charges and no Article Processing Charges as these are fully funded by institutions through Knowledge Unlatched,resulting in no direct charge to authors. For more information about Knowledge Unlatched please see here:

This research has been supported by a National Science Foundation Graduate Research Fellowship (under Grant No. DGE-1762114) and a Ford Foundation Predoctoral Fellowship for Nicole S Kuhn.

Ethics approval

The authors declare that research ethics approval was not required for this study.

ORCID iDs

Nicole S Kuhn

Clarita Lefthand-Begay

References

American Indian Higher Education Consortium and The Institute for Higher Education Policy (1999) Tribal Colleges: An Introduction. Tribal Nations Documents 4.

Around Him

Aguilar

Frederick

, et al. (2019) Tribal IRBs: A framework for understanding research oversight in American Indian and Alaska native communities. American Indian and Alaska Native Mental Health Research 26(2): 71–95.

Becenti-Pigman

White

Bowman

, et al. (2008) Research policies, processes and protocol of the Navajo Nation Human Research Review Board. In: Minkler

Wallerstein

(eds) Community-Based Participatory Research: From Processes to Outcomes. San Francisco, CA: Jossey-Bass, 441–445.

Brockie

Hill

Davidson

, et al. (2022) Strategies for culturally safe research with Native American communities: An integrative review. Contemporary Nurse 58(1): 8–32.

Cardon

(2021) American Indian literature and a legacy of misappropriation. In: Fashioning Character: Style, Performance, and Identity in Contemporary American Literature. Charlottesville: University of Virginia Press, 151–195.

Carroll

Garba

Plevel

, et al. (2022a) Using indigenous standards to implement the CARE principles: Setting expectations through tribal research codes. Frontiers in Genetics 13: 823309.

Carroll

Plevel

Jennings

, et al. (2022b) Extending the CARE principles from tribal research policies to benefit sharing in genomic research. Frontiers in Genetics 13: 1052620.

Carroll

Rodriguez-Lonebear

Martinez

(2019) Indigenous data governance: Strategies from United States native nations. Data Science Journal 18(1): 31.

Coffey

Tsosie

(2001) Rethinking the tribal sovereignty doctrine: Cultural sovereignty and the collective future of Indian nations. Stanford Law & Policy Review 12(2): 191–222.

10.

Datta

(2018) Decolonizing both researcher and research and its effectiveness in Indigenous research. Research Ethics 14(2): 1–24.

11.

Duarte

Vigil-Hayes

Littletree

, et al. (2020) Of course, data can never fully represent reality. Human Biology 91(3): 163–178.

12.

Gaston Anderson

(2003) American Indian tribal Web sites: A review and comparison. Electronic Library 21(5): 450–455.

13.

Gribble

Around Him

(2014) Ethics and community involvement in syntheses concerning American Indian, Alaska Native, or Native Hawaiian health: A systematic review. AJOB Empirical Bioethics 5(2): 1–24.

14.

Haozous

Lee

Soto

(2021) Urban American Indian and Alaska native data sovereignty: ethical issues. American Indian and Alaska Native Mental Health Research 28(2): 77–97.

15.

Harding

Harper

Stone

, et al. (2012) Conducting research with tribal communities: Sovereignty, ethics, and data-sharing issues. Environmental Health Perspectives 120(1): 6–10.

16.

Hayward

Sjoblom

Sinclair

, et al. (2021) A New Era of indigenous research: Community-based Indigenous research ethics protocols in Canada. Journal of Empirical Research on Human Research Ethics 16(4): 403–417.

17.

Hernandez

(2004) Blood, lies, and Indian rights; TCUs becoming gatekeepers for research. Tribal College 16(2): 10.

18.

Hiratsuka

Beans

Robinson

, et al. (2017) Self-determination in health research: An Alaska native example of tribal ownership and research regulation. International Journal of Environmental Research and Public Health 14(11): 1324.

19.

Hudson

Carroll

Anderson

, et al. (2023) Indigenous peoples' rights in data: A contribution toward Indigenous research sovereignty. Frontiers in Research Metrics and Analytics 8: 1173805.

20.

James

Tsosie

Sahota

, et al. (2014) Exploring pathways to trust: A tribal perspective on data sharing. Genetics in Medicine 16(11): 820–826.

21.

James

West

Claw

, et al. (2018) Responsible research with urban American Indians and Alaska natives. American Journal of Public Health 108(12): 1613–1616.

22.

Kelley

Belcourt-Dittloff

Belcourt

, et al. (2013) Research ethics and Indigenous communities. American Journal of Public Health 103(12): 2146–2152.

23.

Kuhn

Parker

Lefthand-Begay

(2020) Indigenous research ethics requirements: An examination of six Tribal Institutional Review Board applications and processes in the United States. Journal of Empirical Research on Human Research Ethics 15(4): 279–291.

24.

Kukutai

Taylor

(2016) Indigenous Data Sovereignty: Toward an Agenda. Canberra: ANU press.

25.

LaFrance

Crazy Bull

(2009) Researching ourselves back to life: Taking control of the research agenda in Indian country. In: Mertens

Ginsberg

(eds) Handbook of Social Research Ethics. Thousand Oaks, CA: Sage Publications, 135–149.

26.

Marley

(2019) Indigenous Data Sovereignty: University Institutional Review Board Policies and guidelines and research with American Indian and Alaska Native communities. American Behavioral Scientist 63(6): 722–742.

27.

Miles

Huberman

Saldaña

(2014) Qualitative Data Analysis: A Methods Sourcebook, 3rd edn. Thousand Oaks, CA: Sage Publications.

28.

Morton

Proudfit

Calac

, et al. (2013) Creating research capacity through a tribally based Institutional Review Board. American Journal of Public Health 103(12): 2160–2164.

29.

Nason

(1996) Tribal models for controlling research. Tribal College 7(2): 17.

30.

Native Center Governance Center (2004) Terminology style guide. Available at: https://nativegov.org/resources/terminology-style-guide/ (accessed 21 August 2023).

31.

Nielsen

Jarratt-Snider

(2020) Traditional, National, and International Law and Indigenous Communities. Tucson: The University of Arizona Press.

32.

Putnam

(2012) “Please don’t feed the natives”: Human zoos, colonial desire, and bodies on display. French Literature Series 39: 55–68.

33.

Quigley

(2006) Perspective: A review of improved ethical practices in environmental and public health research: Case examples from Native Communities. Health Education & Behavior 33(2): 130–147.

34.

Sahota

(2009) Research Regulation in American Indian / Alaska Native Communities: Policy and Practice Consideration. National Congress American Indians Policy Research Center. Available at: https://archive.ncai.org/policy-research-center/initiatives/Research_Regulation_in_AI_AN_Communities_-_Policy_and_Practice.pdf (accessed 19 March 2024).

35.

Siddiqui

Sharp

(2021) Beyond the Belmont Report. American Journal of Bioethics 21(10): 1–4.

36.

Simonds

Christopher

(2013) Adapting Western research methods to Indigenous ways of knowing. American Journal of Public Health 103(12): 2185–2192.

37.

Smith

(2021) Decolonizing Methodologies: Research and Indigenous Peoples. London: Zed Books.

38.

Speckman

Byrne

Gerson

, et al. (2007) Determining the costs of institutional review boards. IRB Ethics and Human Research 29(2): 7–13.

39.

Tom

(2015) Protecting tribal nations through community controlled research: an analysis of established research protocols within Arizona tribes. Master's Thesis, Arizona State University, USA.

40.

Tsosie

Claw

Garrison

(2021) Considering “respect for sovereignty” beyond the Belmont Report and the common rule: Ethical and legal implications for American Indian and Alaska native peoples. American Journal of Bioethics 21(10): 27–30.

41.

Tsosie

(2007) Cultural challenges to biotechnology: Native American genetic resources and the concept of cultural harm. Journal of Law Medicine & Ethics 35(3): 396–411.

42.

US Department of Health and Human Services, Indian Health Service (n.d.) About IHS. Available at: https://www.ihs.gov/aboutihs/ (accessed 20 August 2023).

43.

US Department of Health and Human Services, Office for Human Research Protections (n.d.-a) Available at: https://www.hhs.gov/ohrp/index.html (accessed 6 December 2023).

44.

US Department of Health and Human Services, Office for Human Research Protections (n.d.-b) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in Last 60 Days. Available at: https://ohrp.cit.nih.gov/search/search.aspx?styp=bsc (accessed 20 August 2023).

45.

US Department of the Interior Indian Affairs (n.d.) About us. Available at: https://www.bia.gov/about-us (accessed 20 August 2023).

46.

US Government Accountability Office (2012) Indian issues: Federal funding for non-federally recognized tribes. Available at: https://www.gao.gov/assets/gao-12-348.pdf (accessed 1 September 2023).

47.

Wilson

(2008) Research is Ceremony: Indigenous Research Methods. Black Point, Nova Scotia: Fernwood Publishing.

48.

Yuan

Bartgis

Demers

(2014) Promoting ethical research with American Indian and Alaska Native people living in urban areas. American Journal of Public Health 104(11): 2085–2091.

Indigenous research ethics and Tribal Research Review Boards in the United States: examining online presence and themes across online documentation

Abstract

Keywords

Introduction

Methods

TRRBs dataset

RQ1: Online presence

RQ2: Online documentation

RQ3: Themes in documentation

Codebook with appearance & prevalence of code

Codebook

Appearance & prevalence of code by document type

Overall prevalence of code

Visualizing appearance of code

Results

TRRBs dataset—Table 1

RQ1: Online Presence—Table 2

RQ2: Online Documentation—Table 3

RQ3: Themes in documentation—Table 4, Figure 1

Codebook, appearance & prevalence of codes—Table 4

Codebook

Appearance & prevalence of code by document type

Overall prevalence of code

Visualizing appearance of code—Figure 1

Discussion

TRRBs dataset

RQ1: Online presence

RQ2: Online documentation

RQ3: Themes in documentation

Codebook, appearance & prevalence of codes—Table 4

Codebook

Appearance & prevalence of code by document type

Overall prevalence of code

Visualizing appearance of code—Figure 1

Limitations

Conclusion

Ethical considerations

Footnotes

Funding

Ethics approval

ORCID iDs

References