Product Details

Author Information

Corresponding Author
Nazmim Bhuiya
Institute for Community Health
163 Gore Street
Cambridge, MA 02141
United States
p: 617-499-6679
nbhuiya@challiance.org

Authors (listed in order of authorship):
Alice Chan
Tufts University

Shalini Tendulkar
Institute For Community Health

Jennifer Graf
Cambridge Health Alliance

Julie Carpineto
Institute For Community Health

Product Description and Application Narrative Submitted by Corresponding Author

What general topics does your product address?

Research

What specific topics does your product address?

Research ethics

Does your product focus on a specific population(s)?

Adolescents

What methodological approaches were used in the development of your product, or are discussed in your product?

Community-based participatory research , Focus group

What resource type(s) best describe(s) your product?

Case study, Training material

Application Narrative

1. Please provide a 1600 character abstract describing your product, its intended use and the audiences for which it would be appropriate.*

The underlying principle of the community-based participatory research (CBPR) approach is that both academic and community members have equal partnership and engagement in the research process. Prior to beginning any research that involves humans as study participants, both researchers and community members must be trained on and made aware of the guidelines for ethical research. Increasingly, youth community members are engaged as research partners in CBPR projects. However, currently available human participant trainings often utilize dense content that is not suitable for youth. The training, Ethical Conduct with Human Participants Training, developed as a PowerPoint presentation designed for youth audiences, serves as a simple tutorial highlighting the key principles of conducting research in accordance with State and Federal regulations that Institutional Review Boards (IRB) apply. The training tool is composed of several key content areas: overview of the concept of ‘ethics,’ historical summary of select ethically flawed human participants research, guidelines of the Belmont Report, and regulations that an IRB must follow when reviewing proposed research. The training includes interactive scenarios to facilitate discussion. Additionally, it is accompanied by a Facilitator’s Guide containing instructions and a brief assessment designed to assess youth understanding of, and comfort with, the training content. This training will be particularly beneficial for youth who are engaged as study team members but have a limited background in research.

2. What are the goals of the product?

The overarching goal of the Ethical Conduct with Human Participants Training is to provide youth community members with knowledge of research ethics principles and to help prepare them to engage in the conduct of human research. The training introduces the basic concepts of human research ethics and addresses its origin, importance, and necessity when conducting research. In an effort to underscore the efforts and origins of research ethics review committees (i.e., IRBs), the training discusses historical examples of unethically-designed human experiments. The training provides a basis for youths’ knowledge of universally-recognized ethical regulations to which researchers must abide by for studies involving human participants. This broader historical context equips youth with an understanding of the significance of these guidelines and regulations, including the need for informed consent in human research.

3. Who are the intended audiences or expected users of the product?

This training was originally designed for youth with a limited background in research who lack the training needed to fully engage in the research process, to facilitate their participation as researchers in CBPR projects. This training should be delivered by a person who is well versed in research ethics, the evolution of research ethics, and IRB requirements. It can be delivered by either an experienced researcher or a community member who is knowledgeable about research.

4. Please provide any special instructions for successful use of the product, if necessary. If your product has been previously published, please provide the appropriate citation below.

The training tool is intended to be delivered to youth in a presentation format by adult researchers or community members with experience conducting human participant research. All participants are encouraged to discuss the scenarios presented to facilitate their understanding of the concepts, and reinforce the application of the materials presented. A complementary Facilitator’s Guide provides brief instructions for presenters to effectively deliver the training. It is also recommended that the presenter review the assessment responses with youth participants after their completion to reinforce the training content. Certificates of Completion can be printed and given to participants after youth have successfully finished the training. A sample template is included with the training tool.

5. Please describe how your product or the project that resulted in the product builds on a relevant field, discipline or prior work. You may cite the literature and provide a bibliography in the next question if appropriate.

CBPR is an approach that values engagement of community stakeholders in addressing public health issues. This approach hinges on academic and community partners bringing their respective strengths and expertise to the research. CBPR fosters equitable partnerships in all aspects of the research process and promotes co-learning. (1,2) Engaging the community, particularly youth, in research will produce more meaningful and relevant results (3) that can lead to action that is often initiated and carried out by the youth. However, youth researchers may not have the pre-existing knowledge and/or experience to engage as equal partners in research, particularly as it pertains to the ethical conduct of research. It is important to enhance a community’s capacity to engage in research by providing them with opportunities to develop skills and experience to conduct research (4).

One area in which community partners may not be well versed in, is the guidelines and regulations around protections of human research participants (5); it is important to be informed of and knowledgeable about these requirements and guidelines before conducting human research. To bridge this gap, a critical step is to provide research training to community partners and all members of a study team (5). The Ethical Conduct with Human Participants Training is a structured training tool that provides youth, poised to engage in human research, with basic background and knowledge to engage in the implementation of ethical research with human participants. It also provides youth the opportunity to jointly participate in various stages of research projects, from helping to formulate the research questions, to gathering research data, to disseminating the findings collaboratively with researchers.

6. Please provide a bibliography for work cited above or in other parts of this application. Provide full references, in the order sited in the text (i.e. according to number order). .

1. Israel, BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: assessing partnership approaches to improve public health. Annu Rev Publ Health 1998;19(1):173-202.

2. Minkler M, Wallerstein N, eds. Community-based participatory research for health: From process to outcomes. San Francisco: John Wiley & Sons; 2010.

3. Harper GW, Carver LJ. “Out-of-the-mainstream” youth as partners in collaborative research: Exploring the benefits and challenges. Health Educ Behav 1999;26(2): 250-265.

4. Hacker K, Tendulkar SA, Rideout C, Bhuiya N, Trinh-Shevrin C, Savage CP, Grullon M, Strelnick H, Leung C, DiGirolamo A. Community capacity building and sustainability: outcomes of community-based participatory research. Prog Community Health Partnersh 2012;6(3):349.

5. Hyatt RR, Gute DM, Pirie A, Page H, Vasquez I, Dalembert F. Transferring knowledge about human subjects protections and the role of institutional review boards in a community-based participatory research project. Am J Public Health 2009;99.

6. Wang CC, Morrel-Samules S, Hutchison PM, Bell L, Pestronk RM. Flint photovoice: Community building among youths, adults, and policymakers. Am J Public Health 2004;94(6): 911-913.

7. Checkoway B, Richards-Schuster K. Youth Participation in Community Evaluation Research. Am Journal Eval 2003;24:21-33.

8. Jacquez, Farrah, Lisa M. Vaughn, and Erin Wagner. Youth as partners, participants or passive recipients: A review of children and adolescents in community-based participatory research (CBPR). Am J Community Psychol 2013;51(1-2):176-189.

9. Powers JL, Tiffany JS. Engaging Youth in Participatory Research and Evaluation. J. Public Health Manag Pract 2006; Nov(Suppl):S79-S87.

10. Ashton C, Arnold ME, Wells, EE. Participatory Evaluation of Youth Leads to Community Action Project. J Extension 2010; 48(3):3IAW2.

7. Please describe the project or body of work from which the submitted product developed. Describe the ways that community and academic/institutional expertise contributed to the project. Pay particular attention to demonstrating the quality or rigor of the work:

• For research-related work, describe (if relevant) study aims, design, sample, measurement instruments, and analysis and interpretation. Discuss how you verified the accuracy of your data.
• For education-related work, describe (if relevant) any needs assessment conducted, learning objectives, educational strategies incorporated, and evaluation of learning.
• For other types of work, discuss how the project was developed and reasons for the methodological choices made.

Staff from the Institute for Community Health, a research and evaluation organization dedicated to utilizing participatory approaches founded by the Cambridge Health Alliance (CHA), Mt. Auburn Hospital, and Massachusetts General Hospital of Partners HealthCare, were developing projects that engaged youth as researchers. These projects required IRB review and approval, per Federal regulations. As the research projects were designed to be youth-led, the youth would be considered study team members. For these reasons, it was essential for youth researchers to understand the underlying principles of conducting ethical human research. A component of IRB approval at CHA is research ethics training for all members of the study team, which would require youth researchers to complete such training. Compliance with this requirement propelled the need for a suitable training that would be age-appropriate. As a result, the Ethical Conduct with Human Participants Training was developed in collaboration with the CHA Office of Research Administration and revised and improved with feedback from youth. This training was subsequently implemented with various youth researchers on a variety of participatory projects that ranged in content area from mental health and reproductive health, to substance use and used an assortment of data collection methodologies. Additionally, the personal safety of youth was also addressed as a part of the training for the individual projects. These projects are described briefly below.
• At a local public forum, academic and community partners discussed findings of a needs assessment of Asian adults that was conducted in an urban Massachusetts city. At this forum, mental health issues were voiced, particularly by youth, as a priority for an Asian community. Subsequently, eight youth from the greater Boston area, between the ages of 14 and 19 years, participated in a community-based photovoice project to explore mental health and wellness in the Asian community from their perspectives. Photovoice, a participatory-action research methodology that photographically documents community assets and concerns (6), was chosen as it is a useful way to encourage youth to explore challenging concepts, such as mental health, and provide them with opportunities to contribute to a dialogue related to these concepts.
• As part of a needs assessment phase for a teen pregnancy prevention project in communities with some of the highest teen birth rates in Massachusetts, youth focus groups were held to understand their perceptions of teen pregnancy in their community and access to clinical services. Youth discussed several barriers to accessing services including, confidentiality and lack of respect exhibited by clinical staff. Subsequently, a group of high-risk youth aged 14-19 years, carried out surveys and observational assessments of local clinics to evaluate the identified barriers. They participated in instrument design, data collection and analysis, as well as recommendation development to improve local clinic quality and youth-friendliness of reproductive health services. It was important to engage youth as partners in all phases of the project to ensure that relevant and actionable questions were explored in the assessment and appropriate efforts were made to address their reproductive health needs.
• Youth conducted a research project in which they led focus groups with their peers living in an urban city. That same year, the Youth Risk Behavior Survey (YRBS) revealed that among youth who reported drinking alcohol in the last 30 days, a large percentage reported that they obtained the alcohol from “other” sources. The youth were interested to investigate what constituted “other” sources. They also facilitated focus groups with youth exploring perceptions of harm associated with marijuana use. A youth-led focus group with peers was chosen to gather these data to acquire more meaningful information on a sensitive topic.

8. Please describe the process of developing the product, including the ways that community and academic/institutional expertise were integrated in the development of this product.

This Ethical Conduct with Human Participants Training was adapted from prior training materials developed by ICH staff. The various community research and evaluation projects that ICH has been involved with prompted the development of several iterations of this training tool in efforts to ensure ICH’s community partners’ have the competency related to the conduct of ethical research. The structure of this training is similar to that of the aforementioned versions, as the presentation follows in almost the exact sequence of the presentation of the key content areas, such as historical contexts and specific guidelines. In addition to these shared slides, brief scenario slides are incorporated in the presentation to enhance and assess understanding.

The Cambridge Health Alliance Manager Human Research Protection Program and Research Integrity was also actively engaged in the development of this training tool. Specifically, she provided input on the training content to ensure that the critical elements of human research education were addressed. This involvement and insight into IRB requirements and basic research ethics during the development of the training also facilitated IRB approval of the training module and enabled ICH to utilize this training in our various youth led research projects described above.

ICH staff pilot tested the training with two high school youth groups in urban settings. Youth participants’ ranged in age from 14 to 19 years and included both males and females. The pilot administration included a delivery of the training by an ICH staff person followed by an informal discussion with the youth groups to obtain their feedback. Feedback was elicited on the length of training as well as the content, including readability, the interactive scenarios, and the post-presentation assessment. Because this training is geared toward youth, it was critical to elicit their opinions about the module and areas of potential improvement. Their feedback was incorporated to develop the final training tool. Youth expressed that this training should be presented “live and in-person,” and did not feel that a video or other delivery modes would be appropriate for youth audiences. They thought the length of the training was appropriate. Youth feedback strengthened the organization and presentation of the information on the slides, helping to refine the information/language and creating a balance between text and images. Their feedback also led to the creation of the Facilitator’s Guide. They shared several tips for facilitators to effectively deliver this training, which both prompted and aided the development of the guide. Additionally, they found the assessment to be brief, straightforward, and a good complement to the training.

9. Please discuss the significance and impact of your product. In your response, discuss ways your product has added to existing knowledge and benefited the community; ways others may have utilized your product; and any relevant evaluation data about impact, if available. If the impact of the product is not yet known, discuss its potential significance.

Youth can play a critical role in research and evaluation; their roles can range from participants or consultants to partners and leaders (7). CBPR is an emerging approach that allows youth to equitably collaborate on research projects. The literature shows that there have been CPBR projects exploring youth issues; however, seldom do they engage youth in the actual research process (8). Because the aforementioned projects addressed issues that impacted their lives, it was critical to give youth a voice, particularly youth who are from marginalized communities.

In alignment with CBPR principles, youth were involved in all phases of the research projects described here. Since there are issues pertaining to research ethics that may arise, it is pertinent for youth to understand the guidelines of ethical human research. This training formed a foundation for the youth to understand the elements of research, effectively introduced the background of the IRB, and reinforced the importance of adhering to established research practices and protocols with human participants. Moreover, this training allowed the youth to be included as ‘researchers’ and actively engage in other aspects of the research process that traditionally they may not have exposed to, including data collection through photography, survey administration, observations, and focus groups.

For youth, the potential benefits go beyond serving as partners in research and building research skills – it promotes youth empowerment and youth development (9), which leads to community action (10). This training tool is one strategy that may equip them to not only become researchers and develop professional skills that can be utilized in school or the workplace, but also will give them the confidence to engage on issues that impact their lives.

10. Please describe why you chose the presentation format you did.

PowerPoint, a commonly used business, education, and training medium, was chosen for this presentation. It is a simple, widely available, user-friendly, and readily accessible tool. PowerPoint facilitates the organization and delivery of key information in bullet format, thus making it easy to digest the presented information. A Facilitator’s Guide accompanies the training. This document was developed to provide straightforward instructions to help facilitators effectively deliver the training to youth audiences and ensure youth are engaged and comprehend the training. The supplemental assessment questionnaire consists of seven multiple-choice and true/false questions that tests youths’ knowledge and understanding of the training. This assessment is designed to be brief and simple so that youth are not overwhelmed by the number of the questions and do not experience survey fatigue. Despite the survey’s brevity, the assessment questions reflect the core competencies of the training.

11. Please reflect on the strengths and limitations of your product. In what ways did community and academic/institutional collaborators provide feedback and how was such feedback used? Include relevant evaluation data about strengths and limitations if available.

The fundamental strength of this training is that it distills key information from existing dense and lengthy human research participants trainings. The core principles have been extracted and presented in simplified language to ensure comprehension. This straightforward, concise training tool may be delivered by a knowledgeable and experienced researcher or community partner in approximately one hour, with ample time for discussion. Thus, conducting a brief, simple, and concise training maximizes the potential for active youth engagement throughout the entire presentation.

The inclusion of scenarios in the training reinforces and clarifies the basic principles of a human participants research training. It gives youth an opportunity to participate, reflect, and apply the information learned. The assessment allows for quantitative measurement of understanding and may incentivize youth to focus on the training.

This product is specifically designed for youth and has been used with this audience; however, this training could also be adapted or used with community members and community organization staff to equip them to engage in CBPR efforts as research team members.

As previously mentioned, this product was collaboratively developed with the Cambridge Health Alliance Manager of Human Research Protection Program and Research Integrity with input from two local youth groups. The training was reviewed and approved by the Cambridge Health Alliance IRB prior to youths’ input and was recognized as fulfilling the human participants research training certification requirements for youth co-investigators. However, while this may fulfill training requirements for youth researchers at one institution, it may not do so at another. It is imperative that those interested in adopting this training with youth or other community members consult their IRB and obtain local IRB approval prior to implementing this training.

12. Please describe ways that the project resulting in the product involved collaboration that embodied principles of mutual respect, shared work and shared credit. If different, describe ways that the product itself involved collaboration that embodied principles of mutual respect, shared work and shared credit. Have all collaborators on the product been notified of and approved submission of the product to CES4Health.info? If not, why not? Please indicate whether the project resulting in the product was approved by an Institutional Review Board (IRB) and/or community-based review mechanism, if applicable, and provide the name(s) of the IRB/mechanism.

One of ICH’s core values is utilizing participatory approaches through collaboration and capacity building with community partners. One of the underlying principles of CBPR is to facilitate collaborative partnerships in all phases of a research project (1, 2); all research projects described above upheld this key principle. Youth were trained and mentored to carry out the research projects independently, but with oversight from experienced researchers. The youths’ contribution throughout the research process was valuable and their input was respected by their adult academic co-investigators. Since the youth were considered ‘experts,’ as the research projects explored issues that had an impact on their lives, it was critical to engage them as partners in the aforementioned research projects.

Working in partnership, ICH staff, the youth researchers, and the Cambridge Health Alliance Manager of Human Research Protections and Research Integrity, all played critical roles in producing and refining this training tool. Each contributed their expertise in the development, presentation, and delivery of the content. All feedback was equally valued in the creation of this training.

This training was approved by the Cambridge Health Alliance IRB. The Manager of Human Research Protection Program and Research Integrity was integrally involved in providing feedback on the development of the training. This feedback facilitated conversations and collaboration in the design of an appropriate training for youth. This collaboration aided IRB approval of this training for use in the individual research projects referenced above.

All key collaborators of this training are included as authors on this submission, and therefore have reviewed and approved this submission.