Prevention of Paralytic Shellfish Poisoning in Subsistence Shellfish Harvest Communities of Southeast Alaska
Phase: NA
Conditions: Shellfish Poisoning, Paralytic
Sponsor: University of Alabama at Birmingham

Study Protocol with Informed Consent Form 
Title: R01ES029165, Prevention of Paralytic Shellfish Poisoning in Subsistence Shellfish 
Harvest Communities of Southeast Alaska 
NCT Number: NCT05247229 
Document data: September 25, 2023 
 
 

2. DATA AND METHODS 
2.1 Research Team and Reflexivity 
This study was a partnership between researchers, educators, and 
environmental protection staff at the University of Alabama at Birmingham (UAB), the 
University of California, San Francisco (UCSF), and the Sitka Tribe of Alaska (STA). The 
community-academic partnership was initiated in 2016 when academic partners were 
invited to support the efforts of a Tribe-school district partnership in Sitka and a tribally 
led environmental monitoring program. The partnership involves shellfish toxin testing 
and modeling and K-12 educational programming to promote cultural, environmental, 
and health literacy and increase awareness of shellfish poisoning risk reduction 
strategies and STA risk reduction resources. The intervention evaluated in this study is a 
new education program for middle school students. This work is community co-led and 
participatory (Key et al., 2019), reflects reflexive research ethics principles (Cordner et 
al., 2016), and follows best practices for co-created community engagement in oceans 
and human health research (Carson et al., 2022). Community-based participatory 
research offers a model for fostering trust, reciprocity, and long-term collaboration with 
Indigenous communities (Manson et al., 2004). The research instruments used in this 
study were developed collaboratively by members of the author team with academic and 
STA affiliations. Surveys were conducted by coauthors implementing the education 
program in Sitka, Hoonah, and Juneau and respectively affiliated with STA, the Hoonah 
Indian Association, and the Central Council of the Tlingit and Haida Indian Tribes of 
Alaska. Interviews, across communities, were conducted by coauthors with STA and 
UAB affiliations. This research received human subjects research approval from the 
University of Alabama at Birmingham Institutional Review Board (IRB protocol number 
300006786). In reporting, we draw on three guidelines, including criteria specific to 
health research with Indigenous Peoples (Huria et al., 2019), environmental education 

research (Smith-Sebasto, 2000), and group-based behavior-change interventions (Borek et al., 
2015). We present consolidated criteria for strengthening reporting of health research involving 
Indigenous Peoples in appendix 1 (Huria et al., 2019) and relevant items from the other two 
guidelines in this methods section. 
 
2.2 Middle School Education Program 
 
The middle school education program that this study evaluates teaches participants 
about traditional knowledge and shellfish harvesting practices in Southeast Alaska, risks posed 
by shellfish toxins, and risk reduction strategies. The program was designed by STA, run by 
education and environmental coordinators working for STA, the Hoonah Indian Association, and 
the Central Council of the Tlingit and Haida Indian Tribes of Alaska, and featured guest 
speakers, such as staff scientists responsible for shellfish toxin testing and tribal members with 
expertise in local knowledge and traditional knowledge (Roland, Kohlhoff, Lanphier, Yazzie, et 
al., 2024). The program was initially implemented only in a middle school in Sitka and was 
expanded to schools in Hoonah and Juneau in response to Tribes’ interest. The semester-long, 
one hour program took place weekly, either as an after-school program or during school hours 
as a non-graded elective, depending on the structure most feasible for schools. Lessons offered 
participants hands-on learning such as experience with laboratory techniques, microscopy, 
plankton tows, and shellfish harvesting. The program was divided into two units: the first 
focused on harmful algal blooms and paralytic shellfish poisoning and the second focused on 
intertidal zones and shellfish harvesting. Research activities included pre- and post-program 
interviews and surveys and a follow-up survey one year after participation. Pre- and post-
program surveys were the primary outcome measure of the clinical trial, and pre- and post-
program interviews and the one year post-program survey were secondary measures. 

The program was designed with the TPB in mind and especially targeted control 
beliefs. The program aimed to influence behavioral beliefs by educating students about 
shellfish harvesting through hands-on, place-based learning; normative beliefs by 
emphasizing that harvesting with parents or guardians is customary; control beliefs by 
highlighting exposure risk reduction strategies and tribal paralytic shellfish poisoning 
prevention resources; and, ultimately, behavioral intentions through shifting behavioral, 
normative, and control beliefs.  
 
2.3 Sample and Consent 
 
Study participants were recruited from all middle school students (grades 6-8) in 
Blatchley Middle School in Sitka, Hoonah City School in Hoonah, and Dzantik’i Heeni Middle 
School in Juneau. The program enrolled 11 participants in Sitka, 20 in Hoonah, and 19 in 
Juneau for a total of 50 participants across communities. Research participation was not 
required to participate in the education program, and students opted into the survey and 
interview research components through a tiered informed consent process. Written consent was 
obtained from parents after information on research activities was shared, and verbal consent 
was obtained from participants before data collection activities. Of the 50 study participants, all 
consented to participate in the surveys and all but one consented to participate in the interviews. 
Participants in either or both research components were offered a $10 cash card incentive for 
each lesson attended, with a total possible incentive of $100 for attending all ten lessons. 
Incentives were used to encourage program participation and regular attendance.  
 
2.4 Survey Design 
  
A five-point (1-5) Likert scale survey was administered to participants at the beginning 
and end of the program, as well as one year after program completion. The instrument used in 

these three instances of data collection included 16 questions relevant to the three types of TPB 
beliefs—behavioral beliefs (attitudes toward the behavior), normative beliefs (perceived 
attitudes of peers and respected figures toward the behavior), and control beliefs (perceived 
ability to perform the behavior)—and was divided into two sections. In the first section, on 
shellfish harvesting, questions asked about participants’ perceptions of and experience with 
shellfish harvesting, perceptions of peers’ views about shellfish harvesting, and sense of agency 
and behavioral intentions related to engaging in shellfish harvesting. For example, related to 
normative beliefs: “Most of the people who are important to me would approve of me 
participating in subsistence clam harvesting” (disagree – agree Likert scale). In the second 
section, on checking toxin levels using the SEATOR website, questions asked about 
participants’ perceptions of this risk reduction behavior, perceptions of peers’ views about 
checking toxin levels, and sense of agency and behavioral intentions related to checking toxin 
levels. For example, related to control beliefs: “I am confident that I can check the SEATOR 
website before clam harvesting” (disagree – agree Likert scale). In both sections, the last 
question asked about behavioral changes related to program learning and thus was relevant in 
only the post-program survey. Full survey response data is presented in appendix 2. 
 
2.5 Survey Data Analysis 
2.5.1. Accounting for Missing Data  
Missing data at the person-visit level were imputed for age (n missing = 6) and each of 
the questions (n missing = 9-20, depending on question), treating each person-visit as a 
separate observation. The predictor variables in the imputed model included all question 
responses and all regression model predictors: age, gender identity, Alaska Native identity, and 
site. We used listwise deletion, excluding cases from analysis if data was missing, for gender (n 
missing = 10), Alaska Native identity (n missing = 6), and pre-post-program differences (n 
missing = 9-15, depending on question). No site data was missing. We generated 80 imputed 

datasets via multiple imputation by chained equations (Azur et al., 2011). Across our models, 
the largest average relative increase in variance (RVI) due to nonresponse was 0.44 and the 
largest fraction of missing information (FMI) was 0.55, suggesting that our analysis based on 80 
imputed datasets was reasonable. Statistical analyses were conducted using STATA 18.0 M/P 
(StataCorp, 2023).  
 
2.5.2. Pre-Post-Program Changes in Theory of Planned Behavior Beliefs and Behavioral 
Intentions 
To evaluate pre-post-program changes in beliefs and behavioral intentions related to 
shellfish harvesting, consumption, and risk reduction, we tested the association between pre- 
and post-program responses (i.e., the intervention effect). We included covariates for site (Sitka, 
Hoonah, and Juneau), age, Alaska Native identity (Alaska Native, non-Native), and gender 
identity (girls, boys, and nonbinary). To consider within person pre-post-program changes in 
TPB Beliefs and behavioral intentions, we used generalized estimating equation linear 
regression (GEE) to cluster pre-post measures (Liang & Zeger, 1986). We also evaluated 
differences in pre-post-program changes in TPB beliefs and behavioral intentions among the 
three participating communities and Alaska Native and gender identities using interacted 
models. Results of interacted models are presented in appendix 3.  
 
We present individual participants’ responses to the one year post-program survey as 
the number of participants in this follow-up survey was small. When we closed the study on July 
31, 2024, only 7 participants had completed the program at least one year prior and were 
available for one year post-program recontact, having completed the program in either fall 2022 
or spring 2023 semesters. These participants were all from Sitka. Of these 7 participants, 4 
completed the follow-up survey. One year post-program survey responses are presented in 
appendix 4.  

 
2.5.3. Relationships Between Changes in Theory of Planned Behavior Beliefs and Changes in 
Behavioral Intentions 
 
To characterize TPB constructs most influential in shifting planned behaviors, we again 
used GEE to test the association between pre-post-program changes in TPB beliefs and pre-
post-program changes in harvesting and exposure risk reduction behavioral intentions. Similar 
to the models we used to assess pre-post-program changes, we adjusted for site, age, Alaska 
Native identity, and gender identity. We also adjusted for changes in other TPB beliefs related to 
either shellfish harvesting or exposure risk reduction, depending on the behavioral intention 
outcome.  
 
2.6 Interview Structure 
Together with the surveys, pre- and post-program structured interviews followed a 
convergent parallel study design, with interviews contextualizing the beliefs and behavioral 
intentions measured in surveys. For example, interview questions related to normative beliefs 
asked: “How do the people in your life (friends, family, etc.) feel about subsistence clam 
harvesting? What do you think of their feelings towards subsistence clam harvesting? Have 
these individuals’ feelings about subsistence clam harvesting influenced how you feel about 
harvesting? If so, how?” Like the survey, interviews were organized by TPB constructs. The 10 
question interview script is included as appendix 5. 
 
2.7 Interview Data Analysis 
Interview audio recordings were transcribed using Otter.ai transcription software. 
Coauthors who conducted interviews reviewed these initial transcripts for quality control, 
listening to each recording and editing transcripts for accuracy. A codebook was generated 

using both inductive and deductive approaches. First, codes were identified based on major 
themes in the interview protocol and relevant to the TPB. Next, all transcripts were reviewed to 
identify further themes not captured in deductively developed codes. This grounded theory 
approach was important to identify new themes raised by participants. The inductive coding 
process was open and collaborative, with members of the research team involved in the 
process meeting frequently during coding scheme generation and coding. Each interview was 
coded by a minimum of two research team members. To support high intercoder reliability, team 
members checked intercoder agreement and collaboratively reviewed coding results throughout 
the coding process, identifying differently coded excerpts and reaching consensus on correct 
coding. Data was coded and analyzed using Dedoose software (Dedoose Version 9.2.12, 
2021).  
 

Study No.: «ID»
UAB IRB
IRB use only
Document Approved On: «ApproveDate»
Page 1 of 4
Version Date: 10/04/2021
IRB Form 
Consent to be a Research Participant
Title: Safe Shellfish in Southeast Survey (part of a research project titled “Prevention of Paralytic Shellfish Poisoning in 
Subsistence Harvest Communities of Southeast Alaska”)
Principal Investigator: Matthew O’Madigan Gribble
Funding Source: National Institute of Environmental Health Sciences
Introduction
The Sitka Tribe of Alaska and the University of Alabama at Birmingham are conducting a research study that your child 
could participate in, with your permission. This packet provides information you would need to know before deciding 
whether to involve your child in the study. Your child’s participation is entirely your choice.  
Before making your decision:

Please carefully read this form or have it read to you

Please ask questions about anything that is not clear 
You can keep a copy of this consent form. You are not giving up any legal rights by signing this form.
Purpose of the Research Study
Consuming shellfish can sometimes present a health risk due to Paralytic Shellfish Poisoning (PSP). PSP can lead to 
serious health risks, and even death. This study is being done to determine what children know about harvesting 
shellfish safely in Southeast Alaska, what they believe about harvesting shellfish safely, and if education results in 
changes in their knowledge, beliefs, or behaviors related to shellfish safety. We respect that eating shellfish is an 
important part of culture in Southeast Alaska and do not want to discourage it. Instead, our education efforts are 
intended to reduce the risk of children contracting PSP through the consumption of shellfish.
The Sitka Tribe of Alaska and the University of Alabama at Birmingham have developed education units centered around 
the harvest and consumption of shellfish in Southeast Alaska. The units consist of in-class lessons, field trips, and guest 
speakers from local experts. The program is intended to help middle school students feel like they have some control 
over their ability to prevent PSP toxin exposure by raising awareness of resources for PSP prevention, such as the 
Southeast Alaska Tribal Ocean Research (SEATOR) toxin monitoring program. The units will be offered as an elective 
class (optional) and students taking the class will be able to opt into the research study. These lessons and related 
optional research activities will be facilitated by Sitka Tribe of Alaska, Hoonah Indian Association, and Hoonah School 
District staff. Whether or not students opt into the research will have no effect on their ability to participate in the class 
or on their class grades. 
Study Participation and Procedures
At the beginning and end of the units, we will survey students about their beliefs in eating shellfish safely, and 
about their knowledge on how PSP toxin producing algae live in the environment. Additionally, we will conduct 
short Zoom or in-person interviews with students at the start and end of the education program. Interviews 
conducted over Zoom will be recorded via Zoom and interviews conducted in-person will be audio recorded. A 
year later, we will contact participants to ask if they have harvested shellfish and visited the SEATOR website in 
the past year. 
UAB IRB
Approved
25-Sep-2023

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Version Date: 10/04/2021
IRB Form 
Shellfish Testing and Consumption
The Southeast Alaska Tribal Ocean Research (SEATOR) network posts results of local shellfish toxin testing to their 
website, www.seator.org. On the website, an interactive map displays beaches where shellfish exceed the regulatory 
limit for PSP toxins and are unsafe to eat.
The program will involve the option to consume shellfish following the end of all units. This is done to celebrate 
Tlingit culture and encourage students to practice safe harvesting practices. The shellfish will be harvested a 
week before consumption, frozen, and tested for toxins. If toxin levels are high, the shellfish will not be 
consumed and commercial shellfish will be purchased and used. Students may choose not to eat the shellfish for 
any reason (vegetarian, shellfish allergy, any reason, which students need not share).
Risks and Discomforts 
Most of the risks associated with participation in this research study are low, such as needing to adjust your families’ 
schedule to accommodate the extra education. Other risks include anxiety from learning about PSP. Since this study is 
occurring in a group setting, other risks include stigmatization and psychological distress. Other potential risks include 
the loss of privacy or confidentiality if there is a data breach.
Benefits 
Participants may benefit from a greater knowledge of shellfish toxins and how to reduce risks of harmful exposures.
Compensation 
If opting into participating in research components, your child will receive a cash card as compensation for participation 
in the two short interviews and surveys (up to $100). Your child will receive the participation incentive amount related 
to their attendance regardless of whether they continue in the program. 
You will have access to free shellfish safety testing (paid for by the study) and additional education opportunities for 
your child.
Other Options 
There are no negative repercussions if you decide not to have your child participate in this study.
Confidentiality 
Certain offices and people, other than the researchers, may look at study records. Study records include your child's 
name and contact information, the pre and post education surveys your child completes, and interview data. 
Government agencies and University of Alabama at Birmingham employees overseeing proper study conduct may look 
at study records. These offices include the Office for Human Research Protections, the National Institute of 
Environmental Health Sciences, the UAB Institutional Review Board, and the UAB Office of Compliance. UAB University 
will keep any research records we create private to the extent we are required to do so by law. A study number, rather 
than the participant’s name, will be used on study records wherever possible. Names and other facts that might point to 
your child will not appear when we present this study or publish results.

Study No.: «ID»
UAB IRB
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Version Date: 10/04/2021
IRB Form 
Certificate of Confidentiality
This study has a Certificate of Confidentiality from the National Institutes of Health. The Certificate of Confidentiality 
helps keep others from learning that you participated in this study. UAB will rely on the Certificate of Confidentiality to 
refuse giving out information that might identify your child; for example, if UAB were to receive a subpoena for study 
records.
The Certificate of Confidentiality does not stop you or someone else, like a member of your family, from giving out 
information about your child’s participation in this study. This means you and your family also need to protect your own 
privacy.
The Certificate does not stop UAB from making the following disclosures about you:

Giving state public health officials information about certain infectious diseases,

Giving law officials information about abuse of a child, elderly, or disabled person.

Giving out information to prevent harm to you or others. 

Giving the study sponsor or funders information about the study, including information for an audit or 
evaluation.
Family Educational Rights and Privacy Act (FERPA) Information
The following people may become aware of your child’s participation in the study: other students and parents, teachers 
at the middle school, and study staff. 
Withdrawal from the Study
You have the right to leave the study at any time, without penalty. 
The researchers have the right to stop your participation in this study without your consent for any reason, especially if 
they believe it is in your best interest, or if you were to object to any future changes that may be made in the study plan.
Contact Information
Contact Matthew Gribble at 205-934-3928, or email seator@uab.edu:

If you have any questions about this study or your part in it.  

If you have questions, concerns, or complaints about the research.
You can also contact Jacob Kohlhoff, the Environmental Education Coordinator for the Sitka Tribe of Alaska, at 
jacob.kohlhoff@sitkatribe-nsn.gov. 
If you have questions about your rights as a research participant, or concerns or complaints about the research, you may 
contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. Regular hours for the OIRB are 
8:00 a.m. to 5:00 p.m. CT, Monday through Friday.

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IRB Form 
Consent and Authorization
TO BE FILLED OUT BY PARTICIPANT ONLY
Please print your child’s name and your name below. Then sign one of the consent levels below. 
Name of Participating Child 
Name of Parent or Guardian
Please sign and date below if you agree to allow your child to be in this educational program as well as both research 
gathering activities (survey and interview). By signing this consent and authorization form, you will not give up any of your 
legal rights. We will give you a copy of the signed form to keep.
 
Signature of Parent or Guardian (18 or older and able to consent)
Date              Time
Please sign and date below if you agree to be in this educational program as well as just the survey. By signing this 
consent and authorization form, you will not give up any of your legal rights. We will give you a copy of the signed form to 
keep.
 
Signature of Parent or Guardian (18 or older and able to consent)
Date              Time
TO BE FILLED OUT BY STUDY TEAM ONLY
__________________________________________________________
Name of Person Conducting Informed Consent Discussion
Signature of Person Conducting Informed Consent Discussion
Date              Time