Ifaa Effectiveness Evaluation: A Comparison of Multisectoral Food Security and Resilience Interventions in the Oromia Region of Ethiopia
Conditions: Nutritional Wasting, Nutritional Stunting
Sponsor: Johns Hopkins Bloomberg School of Public Health

June 12, 2023
 
Ifaa Effectiveness Evaluation on Food Security and Nutrition       
NCT05825716

Page 1 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
1 
 
Clinicaltrials.gov NCT05825716 
 
JHSPH IRB Research Plan for New Data Collection 
IRB Version:  11May2023 
 
For new data collection, new data collection plus secondary data analysis, 
biospecimen repositories, and data coordinating center protocols. 
 
DO NOT DELETE ANY QUESTIONS FROM THIS TEMPLATE 
 
PI Name: Shannon Doocy 
 
Study Title:  Ifaa Effectiveness    
IRB No.:  23765   
 
PI Version No. / Date:  Version 4, June 12, 2023 
 
I. 
Aims of the Study:   
The Ifaa Project is a USAID-funded Resilience and Food Security Activity (RFSA) that is being implemented by Catholic 
Relief Services (CRS) and partners in the East Hararghe Zone of the Oromia Region in Ethiopia. Ifaa targets households that 
are participating in Productive Safety Net Programme (PSNP) which is a social protection program administered by the 
Government of Ethiopia that provides food and cash assistance to vulnerable households.  The Ifaa Project will deliver 
multi-sectoral programming in 241 kebeles (sub-districts) in nine woredas (districts) of East Hararghe Zone, however, 
intervention packages vary by location.  The proposed effectiveness evaluation will quantify the impacts of three different 
intervention packages in terms of key project indicators in the areas of household food security, diet, and child nutrition.  
 
II. Background and Rationale:  
Food insecurity and child undernutrition are persistent challenges in Ethiopia. In early 2023, over 22 million Ethiopians are 
food insecure as a result of drought, conflict and rising food prices and the situation is expected to worsen.i  Prevalence 
of chronic malnutrition (stunting) is estimated at 37% and prevalence of acute malnutrition (wasting) is 7% among children 
less than five years of age.  Only 14% of children have adequate dietary diversity and 11% meet the criteria for having a 
minimally acceptable diet.ii 
Ethiopia’s PSNP Programme, launched in 2005, aims to reduce food insecurity and vulnerability by providing economic 
opportunities and building resilience to crises through cash transfers, public works, and nutritional feeding programmes.iii 
The current 5th phase of PSNP targets approximately 8 million vulnerable households over five years, making it one of the 
largest social protection programs in sub-Saharan Africa.  The PSNP program provides unconditional food or cash 
assistance for six months of the year in addition to public works employment that aims to build or enhance community 
assets.iv PSNP aims to enhance food consumption in the near-term while building and support household member’s 
nutritional status by preventing asset depletion.  Evaluations of the PSNP program have observed improvements in food 
security and asset protection at the household level, and at a community level, environmental improvements such as 
reduced deforestation.v 
The overall goal of the Ifaa Project is improved food security of vulnerable households in targeted PSNP communities, 
contributing to a sustained reduction in rural poverty.  To achieve this goal, Ifaa will provide additional multi-sectoral 
interventions to further benefit 60,000 PSNP households in Oromia region, which is Ethiopia’s largest, most populous 
region and also one of its poorest.  These interventions are aimed at strengthening and improving government services; 
agriculture and livelihood opportunities; health and nutrition; water and sanitation; gender and youth empowerment; and 

Page 2 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
2 
 
natural resource management and environment. Ifaa has three different intervention packages which are presented in 
detail in Table 1 (following page). 
 
Table 1: Ifaa Intervention Summary  
Ifaa Basic Intervention Package 
Ifaa Enhanced Supplementary Interventions 
PSNP Systems 
1) Provision of food aid commodities (wheat, oil, and pulse) 
per the PSNP transfer schedule for 3-6 months from January to 
June annually; 2) Food System Taskforce (FSTF) capacity 
building at woreda, kebele and community levels; and 3) 
private sector engagement for food transport. 
Additional activities including: 1) establishment and training of 
Community Technical Coordinating Forum (CTCF); 2) Case 
management capacity building for FSTFs; and 3) private 
sector construction of infrastructure. 
Health and Nutrition 
The primary household level intervention is ensuring health 
and nutrition linkages for Temporary Direct Support (TDS) 
clients. 
Community level interventions include 1) GoE basic health 
extension program; 2) GoE supportive supervision coaching; 3) 
GoE led community SBC sessions; and 4) capacity building for 
gov’t and partners on Community Management of Acute 
Malnutrition (CMAM) Programming.   
Household level interventions will include 1) the Care Group 
Model (CGM) approach; 2) home garden promotion; 3) the 
nutrition budget calculator; and 4) labor and time saving 
technologies. 
Community level interventions are 1) adolescent nutrition 
school clubs; 2) religious leader mobilization and training 
vulnerable groups; 3) audio toolkit against harmful traditional 
practices (HTPs); 4) enhanced SBC tools for health/nutrition 
promotion; 5) additional health extension programs; and 6) 
systems strengthening (woreda, kebele, community). 
Water and Sanitation 
1) Water infrastructure development; 2) improved 
governance via WASH committees; and 3) water source 
monitoring. 
Supplemental WASH interventions including: 1) CLTSH -- 
Community Led Total Sanitation and Hygiene; 2) WASH 
systems assessments and strengthening; 3) Ensuring water 
quality and safety via routine monitoring; 4) Private sector 
engagement of WASH related businesses; School WASH 
Programs; and 5) Market Based Sanitation and Hygiene.   
Natural Resource Management 
Integrated watershed management including 1) Public works 
projects (soil/water); 2) community training in planning and 
sustaining community assets; 3) Implementation of the 
environment and social management framework (ESMF); 4) 
train gov’t staff on participatory watershed planning; and 5) 
enhance participation of watershed committees on 
community asset management. 
Additional interventions include 1) Support to watershed 
management committees to transit to watershed users' 
cooperatives and 2) implement Integrated Water 
Management Plus (IWM+) with risk management and the 
Water Benefits Calculator. 
Gender Youth and Social Development 
Implementation and monitoring of PSNP Gender Targeting 
Provisions whereby pregnant women, mothers of children 
<2yrs, and female headed households w/o able bodied labor 
are exempt from public works labor requirements; women 
work 50% as much time, have lighter tasks and child care is 
provided. 
An Additional suite of interventions including: 1) Community 
Conversations for Adults and Youth to promote inclusivity; 2) 
Male Engagement training on positive gender norms; 3) 
Gender Champions—individual and couple volunteers to 
promote gender norms; 4) Family Life Training on 
strengthening joint-decision making for couples and service 
providers; 5) Dignified Family Approach trainings to promote 
peace and social cohesion; 6) Functional Literacy Training for 
women and youth in leadership; 6) Leadership training for 
women and youth in leadership positions; 7) Youth 
Livelihoods Groups and Volunteerism; 8) Youth Employability 
and Entrepreneurial Training; 9) School Gender Clubs with 
curricula on life skills, gender equity, harmful traditional 
practices and leadership; and 10) Youth Ambassadors and 
Youth Led Community Conversations; 11) GBV training for 

Page 3 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
3 
 
community leaders and members; and 12) Establishment of 
GBV committees at kebele level and support to woreda level 
task forces. 
 
Livelihoods Interventions 
Savings and Lending Groups (SILC Groups) with 20-25 members. 
Groups meet (bi)weekly with monthly visits by Ifaa staff and 
serve as an entry point for livelihoods interventions.  All SILC 
group members will receive 1) financial literacy training (as 
required by GoE, not delivered by CRS); and 2) support and 
training on business development and planning.  All SILC group 
members receive at least one year of follow up and linkages to 
public work interventions. Target: 30% of PSNP public works 
households. 
Additional resources provided to SILC Groups, including 1) 
Engagement of Private Service Providers (PSPs) to enable 
access to sustainable credit and larger loans; 2) Financial 
Education using an expanded ‘Smart Skills’ curriculum 
focusing on savings, smart borrowing and effective financial 
management; and 3) Life Skills Training for Youth (18-29).   
Livelihoods Pathways including 1) On-Farm crop and livestock 
pathways (Target: 75% of SILC Group Members); 2) Off-Farm 
pathways for youth livelihoods diversification such as extension 
agents, value-add processing and production (Target: 20% of 
households); and 3) wage employment pathways for youth 
(Target: 5% of SILC Group Members).  Each pathway has a 
detailed technical training curriculum delivered over a series of 
sessions; additional tailored markets and business skills 
trainings specific to each livelihood pathway. 
Additional supports include: 1) Seven Steps of Marketing 
Training (Target: all on- and off-farm pathways); 2) Climate 
Smart Agriculture to reduce water needs and increase soil 
health and vegetation coverage (Target: 100% of On-Farm 
Pathway); 3) Producers Groups and linkages to 
markets/suppliers/buyers (Target: 20% of On-Farm 
Pathway);  
Access to Finance via formal financial linkages to service 
providers and capacity building for providers (Target: 70% of on- 
and off-farm pathway) 
Selected financial institutions will be provided with a credit 
guarantee fund and capacity building support to help 
facilitate loans.  Private sector value chain assessment and 
financing [to address bottlenecks].  Additional private sector 
engagement (agro-dealers, SILC providers, animal health) 
and linkage facilitation. 
Livelihoods Transfers of US$300 for the poorest 30% of PSNP 
public works households. 
Youth Transfers of $250 for 20% of youth 18-29 (poorest and 
volunteer) participating in the on- and off-farm pathways. 
 
A subset of kebeles (n=70) was randomly allocated to Ifaa Basic and Ifaa Enhanced Packages as part of a cross-RFSA 
learning activity (USAID is supporting to similar projects in other regions of Ethiopia) that is supported by the funder, 
USAID Bureau of Humanitarian Affairs.  This effectiveness evaluation leverages this randomization to compare the two 
intervention packages.  Additionally, 50% of kebeles were selected for livelihoods interventions, which occur in both Basic 
and Enhanced kebeles; livelihoods kebeles were selected based on criteria developed by CRS, but assignment to the 
enhanced vs basic package was random.  Finally, approximately half if Ifaa Project kebeles are ‘the free zone’ where there 
is flexibility in intervention packages of the course of the project.1  The distribution of the three Ifaa intervention packages 
that will compare in the proposed effectiveness evaluation is presented in Table 2 below. 
 
Table 2: Ifaa Intervention Allocation by Administrative Area 
Woredas/Districts 
Study Eligible Kebeles/Sub-Districts* 
Intervention Package 
Ifaa Basic (n=25) 
Ifaa Enhanced (n=34) 
Ifaa Enhanced + 
Livelihoods (n=35) 
Babile 
Gemechu 
Lekolo 
Erer guda 
Ifa 
Shek husen 
Gambela 
Jalale 
Tofiq 
Ibada gemechu 
  
Tuluhoro 
Nejata  gemechis 
Chinaksan 
Chelchale 
Biftuu Waree 
Amola 
Kobobika 
Gela 
Baduelemo 
 
1 These kebeles were not considered in the sampling frame because of the high risk of contamination. 

Page 4 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
4 
 
Migira 
Kaleroga 
Dawe kora 
Tiro gudoo 
Orda sost 
Dembesele 
Wachuhulet 
Tirosendare 
Kocher 
  
  
Merer 
  
  
Mudi dawe 
Deder 
Burka Bereka 
Gegewisa 
Burka Geba 
Mumicha 
Haremfemekuni 
Cheka gemechu 
Nedi gelansedi 
Huffe 
Chela Negeya 
  
Kura deder 
Golu 
  
Lemen welteha 
Oda kebena 
  
  
Welteha gudina 
Fedis 
Bareda 
Bid Borra 
Ido Baaso 
Bedatu 
Efitu dada 
Kerensa lencho 
  
Negaya bobasa 
Umer kule 
  
Risiki 
  
Gursum 
Ebsa 
Berite 
Awdal 
Hariro 
Gara wadaja 
Day feres 
Misira 
Gefire guda 
Harashi 
Saqabadii 
Goro siyo 
Kasa oromiya 
  
Kebso 
Oda oromiya 
  
Negeya 
  
Jarso 
Aneno mite 
Amen 
Afgug 
Burka mete 
Epa jalela 
Chala 
Debub debelo 
Gidiya licha 
Gara abdula 
  
Oda muda 
  
Melka Belo 
Fule negeya 
Bifitu negeya 
Chefe Jeneta 
Haka mulisi 
Daba kenisa 
Dire Qufa 
Tokuma bilisumu 
Mulisa hakwa 
Welikituma bilusuma 
  
Tokuman kane 
  
Midega Tola 
Ibiro musa 
Kerensa 
Bilisuma 
Terkafeta 
Mukura 
Biyo waraba 
  
  
Lencha 
  
  
Roba 
*Excludes free zone kebeles (where intervention packages may change) and Ifaa Basic+Livelihoods 
kebeles; **one kebele excluded as a potential study location due to access concerns 
 
As the Ifaa consortium learning partner, JHSPH has been requested to design an effectiveness evaluation of the different 
intervention packages to compare their outcomes in terms of key project indicators.  The effectiveness evaluation will be 
independently designed and managed by JHSPH with the engagement of a private data collection firm. 
 
 
III. Study Design: 
A. Study Design Overview  
This study will leverage randomization of the Ifaa Basic and Enhanced Interventions and partial coverage of livelihoods 
interventions to compare the outcomes of three different intervention packages as illustrated in Figure 1.  As part of the cross-
learning activity, 70 Kebeles will have enhanced interventions (including nutrition interventions such as Care Groups2 and 
 
2 Care Groups, is a group of 10-15 volunteer, community health educators who regularly meet together with CRS project staff for 
training and supervision. Each of these volunteers then go out at least monthly to do health promotion with a small cohort of mothers 
of young children. Each volunteer is selected by the mothers she serves and is responsible for regularly visiting a relatively-fixed group 
of 10-15 of her neighbors each month, sharing what she has learned and facilitating behavior change at the household level.   

Page 5 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
5 
 
CCFLS3), and of these 50% (n=35) will have enhanced livelihoods interventions (package varies by location) while half will 
not have livelihoods programming; a total of 50 Kebeles will have the only “basic” intervention package, and of these 50% 
(n=25) will randomly have the basic livelihoods intervention. Restricting the study to Kebeles that underwent 
randomization has methodological benefits as compared to a quasi-experimental design that would be required if the 
study was expanded to other project areas.  An overview of the study flow is presented in Figure 2.  
 
 
Figure 1.  Ifaa Interventions and Study Groups 
   
Ifaa Livelihoods Programming 
Yes 
No 
Ifaa Basic Intervention Package 
not a study arm 
X 
Ifaa Enhanced Intervention Package 
X 
X 
 
As noted in Figure 1, the study includes three of the possible four Ifaa intervention combinations.  Characterizing the 
impact of livelihoods programming without the Ifaa enhanced intervention was not considered a priority. 
Figure 2. Study Flow Diagram 
 
 
A longitudinal cohort design will be used to compare the effectiveness of three Ifaa intervention packages among PSNP 
beneficiaries: 1) the Ifaa basic package; 2) enhanced package without livelihoods; and 3) enhanced package with 
livelihoods. Under this approach, the enrolled households will have either a pregnant woman or children <36 months of 
age.  Households will be followed over a two-year period, with the baseline and endline survey conducted at a similar time 
 
3 Community led complementary feeding sessions (CCFLS) is a six month program targeted at children at risk of acute malnutrition or 
recently discharged from a malnutrition treatment program.  It includes caregiver training on child feeding practices and growth 
monitoring and is a six month intervention, with intensive services/training in the first month and follow up monitoring. 

Page 6 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
6 
 
period in the calendar year to avoid seasonal changes in food security.  The magnitude of change in key indicators over 
time will be assessed for each group; if needed, adjusted models will be used to account for baseline differences between 
groups.  Outcome measures of focus are aligned with Ifaa indicators and include measures of household food consumption 
and child diet. To ensure adequate geographic coverage, a stratified sampling design will be used as follows: 
(1) Kebele Selection. Two kebeles per intervention arm will be purposively selected in each of the nine woredas with 
the aims of 1) of maximizing geographic similarity in terms of agro-ecological zone (lowland, midland, highland) 
and remoteness; and 2) ensuring sufficiently large beneficiary population is available for sampling purposes.  In 
the case of smaller kebeles where it appears unfeasible to attain three clusters, the sample may be distributed 
across additional kebeles within the woreda.4 
(2) Cluster Selection.  Within each kebele, the three largest communities and/or population concentrations from 
within each kebele will selected as cluster start locations.  This approach was identified to account for inclusion 
criteria, notably that households must have a pregnant woman or a child <36 months of age, which reduces the 
number of households that are eligible for study participation.5  Once start locations have been identified, all 
beneficiary lists will be verified, and households that meet inclusion criteria will be enumerated.  This process will 
occur immediately prior to the start up of data collection in the kebele.  If fewer than 20 eligible households are 
identified in the community, enumeration will continue in adjacent communities until the target sample size is 
identified.   
(3) Household Selection.  Data collection will begin within several days of the household enumeration exercise.  
Households will be sampled from the lists of beneficiaries that are verified as meeting inclusion criteria.  In some 
cases, this may be exhaustive (e.g. in kebeles with small populations where adjacent communities needed to be 
visited to identify the target number of households).  In larger kebeles or communities where the number of 
eligible households exceeds the target sample, a systematic list-based sampling approach (i.e. every nth 
household) will be used.  Replacement sampling will be used until the target number of households in each 
location are enrolled. 
 
B. Sample Size  
The primary outcome measure for the evaluation is improvement in household food security.  To align the evaluation with 
project aims, key project indicators are used as study outcome measures.   These include: 1) At the household level, Poor or 
Borderline Food Consumption Score (FCS); and 2) at the individual level, change in minimum dietary diversity among children 
<5 years. Sample size calculations are presented in Table 3 (following page) and are based on both primary and secondary 
outcome measures for within-group change over time using available data from the Ifaa baseline along with Ifaa targets for 
change. Assumptions included the following: 1) power (1-β) of 80% and significance of α=0.05; 2) a design effect of 1.5 to take 
into account differences across Kebeles; and 3) expected absolute change in proportion of primary/secondary outcome; and 4) 
loss to follow up rate of 20% over the study period. Based on initial sample size projections, a minimum sample size of 915-
1,070 households per group and 2,745-3,210 is required which is sufficient to detect differences ≥8% between groups for both 
the primary and secondary outcome measures.   
We are proposing a planned sample size of 1,080 per group or 3,240 households total.  Given challenges in field coordination 
across multiple teams and delays in data quality monitoring reviews, it is possible that several additional households could be 
enrolled in a kebele.  To ensure that the approved sample size is not inadvertently exceeded due to communication challenges 
we a requesting approval for a maximum sample of 3,500 households. 
 
                      Table 3: Sample Size Calculations 
 
Baseline Value 
Magnitude 
of Change 
Sample Size 
per Group 
Total 
Sample Size 
34% in Oromiya (WFP, 2021) 
-8% 
915 
2745 
 
4 The number of beneficiary households per kebele ranges from approximately 75 to 650; given inclusion criteria it is unlikely that 
smaller kebeles will have 60 eligible households, in which case cluster(s) will be assigned in additional kebeles in the woreda. 
5 In the baseline survey, the average number of children <5years in PSNP households was 0.83 and 14% of the population was <5 
years of age.  Based on this we estimate that 15-25% of Ifaa beneficiary households will meet study inclusion criteria.   

Page 7 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
7 
 
Poor or borderline 
household food 
consumption (FCS) 
-10% 
609 
1827 
-12% 
402 
1206 
48% in E Hararghe  
(UMN, 2020) 
-8% 
1070 
3210 
-10%* 
674 
2022 
-12% 
481 
1443 
Minimum dietary 
diversity among children 
<5 years 
19.5% in Oromya  
(2019 DHS) 
+8% 
785 
2355 
+10% 
533 
1599 
+12% 
366 
1098 
        
          *denotes Ifaa change target 
 
C.  Does your study meet the NIH definition of “clinical trial”: ““A research study in which one or more human 
subjects are prospectively assigned to one or more interventions (which may include placebo or other 
control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”?   
 
Per the JHSPH IRB’s determination, this study meets the definition of a clinical trial. 
IV. Participants: 
A. Inclusion Criteria:  
- 
Households are PSNP clients  
- 
Households are Ifaa Project beneficaries that are planned participants in: 1) SILC groups (Ifaa Basic); 2) SILC 
Groups AND Care Groups (Ifaa and Enhanced); or 3) SILC groups AND Care Groups AND a Livelihoods Pathway. 
- 
Households have a pregnant woman OR at least one child <36 months of age 
- 
Households have an adult member that is capable of giving informed consent and completing an interview 
 
B. Exclusion Criteria:  
- 
Child headed households (all members age 17yrs or less) 
- 
Individuals not mentally able to give informed consent and complete an interview 
 
V. Study Procedures:  
 
A. Recruitment Process: 
1. Describe how you will identify, approach, and inform potential participants about your study.  Include 
details about who will perform these activities and their qualifications. 
The JHU team will receive the list of PSNP households/Ifaa beneficiary households living in the sampled Ifaa 
Kebeles from CRS Ethiopia team. Trained enumerators will conduct a verification exercise and visit households 
on the list to confirm eligibility.  After the verification exercise, a second visit will be made to selected households 
where enumerators will explain the study purpose, households will have the opportunity to ask questions, and 
oral consent will be obtained.  Any adult household member will be eligible to participate, however, preference 
will be given to caretakers of young children/pregnant women followed by household heads.   
2. Address any privacy issues associated with recruitment.   
The recruitment procedure is expected not to put the potential study populations at risk. The study topic is not 
sensitive in the population and PSNP and Ifaa beneficiary status is already known among communities.   
 
B. Consent Process:   
1. Describe the following details about obtaining informed consent from study participants.  If a screening 
process precedes study enrollment, also describe the consent for screening. 

Page 8 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
8 
 
a. Who will obtain informed consent, and their qualifications: 
A private Ethiopian data collection firm will be contracted to conduct the two household surveys.  The data 
collection firm will use experienced interviewers.  Prior to data collection, interviewers will be trained on the 
consent process and the data collection tool; training will co-led by a JHU research team member. 
 
b. How, where, and when the consent discussion(s) will occur: 
The consent discussion will occur at the beginning of the home visit for the enrollment interview.  The enumerator 
will identify a quiet and private place in or near the household so that privacy can be maintained and interruptions 
avoided. The enumerator will read the consent statement aloud to prospective participants.  They will have an 
opportunity to ask questions and discuss participation with the interviewer prior to consenting to participate.  
c. The process for determining whether a potential participant meets eligibility criteria.  If you will collect 
personally identifiable information for screening purposes, collect only data needed for this purpose 
and explain what will happen to the data for individuals who are not eligible: 
As described above, Ifaa beneficiary lists will be used will be used for recruitment.  Households on the list will be 
reviewed by Ifaa staff, government extension workers and/or enumerators prior to the start of data collection to 
determine if households are eligible, and if eligibility is unknown household visits will be conducted to verify eligibility.   
d. Whether you will obtain a signature from the participant or will use an oral consent process: 
Oral consent will be used due to high levels of illiteracy. 
e. Whether you will obtain a legally authorized representative’s signature for adults lacking capacity: 
We do not plan to enroll individuals lacking capacity. 
 
f. 
If children are included in the study, if and how you will obtain assent from them: 
We will obtain anthropometric measurements on children that are  <5 years of age at baseline and endline.  Mid-
upper arm circumference, weight and height will be collected.  Child assent will not be obtained because of the 
young ages; instead consent of a parent or adult household member will be requested.  
 
g. If children are included in the study, how you will obtain permission for them to participate from their 
parent, legal guardian, or other legal authority (if child is in foster care or under government 
supervision).  If any of the children are “wards of the state”, additional regulatory requirements will 
apply: 
During the consent procedure, the enumerator will inform the anthropometric measurement of a child and will 
get permission from his/her mother. 
h. If you are seeking a waiver of informed consent or assent, the justification for this request: 
No, we will not have any waiver of informed consent for this study. 
i. 
Whether you will include a witness to the consent process and why: 
No, we will not have a witness to the consent process; this is not common practice in this setting. 
j. 
If the language is unwritten, explain how you will communicate accurate information to potential 
participants and whether you will use props or audio materials: 
Not applicable, the language is written. 
2. Identify the countries where the research will take place, and the languages that will be used for the 
consent process.   

Page 9 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
9 
 
 
 
 
 
 
 
 
 
C. Study Implementation:  
 
1. Describe the procedures that participants will undergo.  If complex, insert a table below to help the 
reviewer navigate.   
Following the consent process, the enumerator will use a tablet to conduct the baseline survey. The enumerator 
will secure a quiet place within or nearby the participant’s residence to ensure privacy. The enumerator will read 
each question in the tablet to the study participant and record their answer to the tablet. The enumerator will 
provide explanation if study participants are not able to understand a question. The same procedure will be used 
for the endline survey. When the interview is over, the enumerator will request to take anthropometric 
measurements (weight, height, arm circumference) for all children <5 years of age.  
The study households will be visited at two time points prior to intervention start up and again after 24 months 
of intervention exposure to ensure data is collected during the same season.  The location of each household will 
be recorded with GPS and a hand-drawing map to ensure feasibility of follow up. A structured questionnaire will 
be used to collect data at both the household and individual child level, with data collected for all children <5 
years of age in the household.  The baseline and endline questionnaire will include the same content, with the 
exception of a module that will be added (in a future modification) to characterize Ifaa intervention participation 
and satisfaction.  Questionnaire content will include background information on primary care taker (e.g. literacy, 
age, pregnancy status) and household characteristics (e.g. size, residence location) and household food security 
measures including Food Consumption Score, Household Hunger Scale, and Coping Strategies Index.  For children, 
individual level information to be collected includes child background information (e.g. age, sex); Infant and Young 
Child Feeding Indicators; and anthropometric measurements (weight, height/length, arm circumference).  
2. Describe the number and type of study visits and/or contacts between the study team and the 
participant, how long they will last, and where/how they will take place. 
Each study participant will have three contacts by enumerators, two at baseline including one to determine 
eligibility and one to complete the interview (May 2023) and one at final evaluation (May 2025). All study visits 
will be made at the participant’s residence. The survey will take 40 to 50 minutes and each interaction is 
anticipated to be one hour or less. 
2. Describe the expected duration of the study from the perspective of the individual participant and 
duration overall. 
From the participant’s perspective, the overall study duration will be two years. The baseline survey and consent 
process will take less than one hour and the same process will be repeated at the endline survey. 
3. Provide a brief data analysis plan and a description of variables to be derived.  
The outcome variables of focus at the household level will be measures of food security, including 1) Food 
Consumption Score, 2) Household Hunger Scale, and 3) Coping Strategies Index.  At the individual level, outcome 
variables of focus will include 1) Infant and Young Child Feeding Indicators (in particular achievement of minimum 
dietary diversity); and 2) prevalence of stunting and wasting, in accordance with the World Health Organization 
Child Growth Standards.   Background information on individual (e.g. literacy, age, pregnancy status) and 
household characteristics (e.g. size, residence location) will also be collected so that these can be controlled for 
or used for disaggregation in data analysis. All outcomes will be analyzed as continuous variables and as categorical 
variables based on pre-determined thresholds. 
Country 
Consent Document(s) 
(Adult Consent, Parental Permission, 
Youth Assent, etc.) 
Languages 
Ethiopia 
Adult Consent, parental permission 
Afan Oromo 
      
      
      
      
      
      

Page 10 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
10 
 
A descriptive analysis of household sociodemographic characteristics and outcome measures will be performed. 
Continuous variables will be presented as mean (SD) and categorical variables as n (%). ANOVA tests will be 
conducted for baseline characteristics and primary and secondary outcomes to examine the comparability 
between the three and intervention groups; individual/household characteristics with significant differences 
between groups at baseline will be controlled for in models that estimate the effect of the interventions. 
The program effect on expected primary outcome measures will be estimated using mixed-effect linear regression 
analysis for continuous outcomes and Generalized Estimation Equation (GEE) model for binary outcomes. In the 
mixed-effects models, the random effect component included indicators to control for clustering at school levels. 
The fixed component included the intervention group (intervention vs. control), time and an interaction term for 
group and time. The GEE models will be used to examine binary outcomes with longitudinal data from both 
enrollment and endline. These models will estimate the change in a binary outcome among members of a given 
intervention group from enrollment to endline, compared to the change in the same outcome in the control. The 
GEE models also included an interaction term between the intervention group and time (baseline/endline).   
5. Answer the following if they are relevant to your study design: 
 
A. If the study has different arms, explain the process for assigning participants (intervention/control, 
case/control), including the sequence and timing of the assignment. 
 
The selected sites will be purposively allocated to 1) the Ifaa basic package (comparison); 2) basic package + 
care groups (intervention 1); and 3) basic package + care groups + livelihoods (intervention 2) by CRS and 
other implementation partners in ifaa project. The JHU research team is not engaged to the assigning 
interventions.  
 
Sections B thru F are not relevant.  
 
VI.  Data Custody, Management, Security, and Confidentiality Protections:   
1. Data Sources:  Identify the source(s) of data. 
     ☒   Participant/Parent-Guardian/Legally Authorized Representative                                                       
     ☐   JHM Medical Records (from Epic)   
Note for JHM Data Users Only:  Please complete the Data Trust Risk Tiers Calculator available on the Applications and 
Forms page on the JHSPH IRB website: [https://tinyurl.com/2p96md3s] and upload a copy of the documents to the 
“Miscellaneous- Other” section of your PHIRST application. 
  
In addition, review the Data Protection Attestation for Research and/or Healthcare Operations at: 
[https://tinyurl.com/yszfkuur] and certify your attestation of compliance to those requirements. 
               ☐   I certify my attestation of compliance to JHM Data Protection Requirements 
☐   Non-JHM Medical Records  
☐   Outside Data Provider (CMS, National Death Index, Insurance Co., etc.)                                                                   
☐   Other Existing Records (please specify):   
       
2. Data Content:  Will you collect, use, and/or record personal identifiers about study participants for any purpose?  
Please look at the list of identifiers in Question 3 to help answer this question. Note:  Limited Data Sets (including 
dates, ages, and zip codes) are considered to be “identifiable”. 
☒   Yes:  Continue with Question 3 

Page 11 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
11 
 
☐   No:  Skip to Question 6 
3. Data Identification:  Identify the Personally Identifiable Information (PII)/Protected Health Information (PHI) you will 
access/collect by checking the box(es) below for “Recruitment” and “Study Data” needs. 
 Recruitment 
Study Data 
PII/PHI to be Accessed/Collected 
 
☒  
☐   
Name, signature, initials or other identifiable code 
 
☐   
☒   
Geographic identifier (address, GPS location, etc.) 
 
☐   
☐   
Dates (birth, death, clinical service, discharge, etc.) 
 
☒   
☒   
Contact information (phone number, email address, etc.) 
 
☐   
☐   
Identification numbers (SSN, driver’s license, passport, etc.) 
 
☐   
☐   
Health records identifiers (medical record #, insurance plan, etc.) 
 
☐   
☐   
Text of clinical record notes 
 
☐   
☐   
Device identifiers (implants, etc.) 
 
☐   
☐   
Internet identifiers (IP address, social media accounts, etc.) 
 
☐   
☐   
Biometric identifiers (fingerprints, retinal scan, voice print, etc.) 
 
☐   
☐   
Audio Recordings 
 
☐   
☐   
Video or full-face photographic images 
 
☐   
☐   
Genomic / Genetic data 
 
☐   
☐   
Other identifiers (list here):          
4. Identifiers:  If you have checked any of the boxes above, how will you protect personal identifiers? 
☒   Will delete all identifiers (explain when you will delete identifiers):   
All unique identifiers will be deleted after endline data collection is completed. 
☐   Will separate identifiers from analytic data and will store the link/code.  Please explain where you will  
store the link/code:  
☐   Will use a method to make it harder to connect the data with the study participant (jiggering date, use 
other methods to obfuscate, etc.).   
5. Data Transit Plans and Protections:  Identifiable data may transfer, sometimes with multiple steps, from mechanisms 
for collection to storage.  For example, participants may complete a web-based survey, which is then downloaded to 
a storage platform.  Briefly identify these steps and the protections for each step (including encryption used at each 
step). 
☐   Will delete all identifiers prior to transfer.   
       ☐   Will separate identifiers from analytic data and will store the link/code prior to transfer.  Please explain   
where you will store link/code:   
        ☒   Other (please specify):  Data will be collected in an online survey platform using tablets and will be transferred 
from devices to a secure online server either immediately after the interview or at the end of the day (depending 
on cell phone coverage).  We do not anticipating deleting or separating identifiers during data collection to help 
facilitate coordination of data collection and data quality monitoring. 
6. Device(s) used for data collection:  Identify the computing device(s) being used for identifiable data 
receipt/collection.  Check all that apply. 
We understand that resources in low resource countries may require use of systems that are not pre-approved.  The 
following are examples of platforms/storage solutions that are not pre-approved to store identifiable information 
and require a risk assessment from JHSPH Data Security.  Do not hesitate to contact [jhsph_cybersecurity@jhu.edu] 
for an assessment. 
• JHU Independent Departmental Servers 

Page 12 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
12 
 
• Local Computer owned by JH 
• Other computers or devices owned/managed by study team members and used for other than secure web 
access 
• USB/Portable data storage device 
• Other solutions not managed by IT@JH, e.g., commercial cloud storage (Box, Dropbox, iCloud, personal 
OneDrive, Google Drive, Amazon storage, etc.) 
     ☐   Provided or managed by JHSPH IT 
     ☒   Study-provided, and not managed by JHSPH IT.  These must include the following protective controls: 
• Data  encrypted while “at rest” (on a storage device) 
•   Security patches and updates are routinely or automatically applied 
•   Devices have access controls so that: 
o   Each person accessing the device is uniquely identified (username) 
o   Passwords are sufficiently strong to prevent compromise 
o   All access is logged and recorded 
o   Unauthorized access is prevented 
• Approved access list is reviewed periodically for correctness 
      ☐   Other (please specify):        
 
7. Data Collection:  Describe the format of data received/collected.  Check all that apply. 
☐   Paper/Hard Copy (must be secured in transit and placed in a secure cabinet/room)                                    
☐   Audio recording   
☐   Video recording                                               
☐   Received directly by research team member and entered into file/database 
☐   Mobile or Web App (custom developed).  Review [guidance] and provide attestation of compliance 
☐   Mobile or Web App (purchased).  Specify product and version:        
☒   Online survey.  Specify mechanism/platform:    www.kobotoolbox.org 
☐   3rd party collector (please specify):         
☐   Existing data shared with JHSPH by data provider via electronic access/transfer 
☐   Duplicate and backup copies will be secured with same rigor as original data            
☐   Other (please specify):         
 
8. Devices/Platforms used for Analysis, Storage, Processing:  Identify where the identifiable or de-identified data will 
be analyzed/stored.  Check all that apply. 
☒   Pre-approved storage and analysis platforms managed by JH/JHSPH for which security and risk mitigation 
measures are known. 
       Identify pre-approved storage platform(s) being used: 
JHM Preferred: 
 ☐   JH SAFE Desktop    ☐   JH PMAP  
 
Other Approved Platforms: 
☒   JH One Drive/JHSPH OneDrive     ☐   JH IT-Managed Network Storage     ☐   JHM/JHSPH Qualtrics 
☐   JHSPH HPCC     ☐   JHSPH SharePoint     ☐   JHSPH Shares     ☐   JHU REDCap  

Page 13 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
13 
 
☐   MARCC-Secure Environment 
 
☒     Platform(s) not managed by JH/JHSPH, not pre-approved, and require a risk assessment review from JHSPH Data 
Security.   
• Describe the not pre-approved platform(s) you plan to use:  It is possible we may need to store data on 
separate commercial storage site so that it also can be accessed by colleagues in the filed (often use JH 
OneDrive is not feasible due to poor connection and login issues with partners.  If this is required, we will 
likely use the DropBox Platform because the Health Systems Program maintains a license and the study team 
is already using it. 
• Describe the technologies you intend to use (software, hardware, connectivity) with a focus on the measures 
taken to secure collected data along the continuum of data collection, storage, transmittal and access:   
We plan to use Kobo Toolbox for data collection and transmission to a secure online server.  Data is encrypted 
and this is an accepted platform used on widespread basis by our partner organizations. 
  
9. Access to Data and Access Controls:  How will you ensure that only authorized individuals can access the data?  What 
access controls will you put into place to ensure that only authorized individuals may access and use the data.  (For 
example, OneDrive [guidance] illustrates how to share files with “people you specify”.  [JHSPH Shares] addresses 
providing permissions to individual people.)  Check all that apply.  Note:  If you need assistance implementing secure 
access controls, contact [jhsph_cybersecurity@jhu.edu] 
 
☒   Will provide access to data in accordance with OneDrive/JHSPH-Shares guidance posted on JHU IT websites 
☐   Will use secure access controls to limit access to individual-level data  
☐   Will use secure access controls to provide other researchers controlled access only to aggregated study data 
 
10. Data Sharing:  Clarify if data are to be shared externally with third parties, including sponsors and other investigators, 
and whether only aggregated data will be shared, or if you will share individual-level data.  Describe sharing and 
protection plans for that sharing, including the proposed use of data agreements.   
Consider the following: 
• 
Information about your data sharing in the consent forms 
• 
Information about data sharing laws in the country where data will be collected, and if they limit sharing, how 
you will comply with those limitations? 
• 
Whether data will be shared in aggregate only, or individual level data 
• 
Whether you plan to make the data publicly available, and in what form. 
☐  Will not share data with outside investigators 
☒  Will make publicly available 
☐  Will share with restrictions/controls 
☐  Will share aggregated data only 
☒  Will share individual-level data without identifiers 
☐  Will deposit data into an existing data repository for future research.  Please explain:         
☐  Future research use and data sharing will have limited purposes.  Please explain:         

Page 14 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
14 
 
 
A. Certificate of Confidentiality: 
All NIH studies include Certificate of Confidentiality (C of C) protections with the grant; the consent form 
must include the C of C language provided in our template.  Other funders may obtain C of C protections 
through NIH.  [https://grants.nih.gov/policy/humansubjects/coc.htm]  
 
Does the study have Certificate of Confidentiality protections?  Yes ☐   No ☒ 
 
VII. Risks of the Study: 
A. Describe the risks, discomforts, and inconveniences associated with the study and its procedures, including 
physical, psychological, emotional, social, legal, or economic risks, and the risk of a breach of confidentiality.  
Include risks beyond individuals to include the study population as a group and community risks. Ensure that 
the risks described in the consent documents are consistent with the risks outlined in the research plan. 
       We do not anticipate any physical, psychological, emotional, social, legal, economic or breach of confidentiality 
risks to the study participants.  The data being collected is not sensitive.  The primary inconvenience for 
participants is time spent to participate in the study which is anticipated to be no more than two hours over the 
two year study period.    
     
B. Describe steps you will take to mitigate or minimize each of the risks described above.  Include a description 
of your efforts to arrange for care or referral for participants who may need it. 
 
The JHU research team will ensure the data collection team receives training in privacy and confidentiality using 
content developed based on guidance from the JHSPH IRB.  It is anticipated that data collectors will not have 
access to interview data after it has been transmitted from tablets and that only a small number of study teams 
will maintain access to the data, thereby reducing risk of breach of confidentiality. 
 
C. Describe the anticipated frequency and severity of the harms associated with the risks identified above; for 
example, if you are performing “x” test/assessment, or dispensing “y” drug, how often do you expect an 
“anticipated” adverse reaction to occur in a study participant, and how severe do you expect that reaction to 
be?   
Data will be collected two times, 24 months apart and involves only an interview and anthropometric 
measurement.  We do not anticipate a significant chance of harm. 
 
D. Describe the research burden for participants, including time, inconvenience, invasion of privacy in the 
home, out of pocket costs, etc.  
 
We expect each round of data collection to require less than one hour for participants.  There will be no out of 
pocket costs.  Data will be collected at or near the respondent’s home.  The participant and interviewer will 
mutually agree on a private location, such that data collection can occur outside the home if invasion of privacy is 
a concern. 
 
☒  Other sharing information:  We believe that data must be made publicly available because this work is 
funded by USAID.  Additionally, many open access journals require that de-identified data sets be published.  
We plan to publish deidentified data on Humanitarian Data Exchange at the end of the study. 
11. Duration and Destruction:  Explain how long data will be retained and the plan for eventual return, deidentification 
or destruction of data, including moving data to an archive. 
We anticipate maintaining identifiable data for approximately 25-30 months, during study data collection and data 
verification/cleaning.  After data cleaning is completed, all unique identifiers will be removed from the data and 
only a copy of de-identified data will be maintained.  If GPS coordinates are maintained, a central cluster coordinate 
will be used instead of specific household locations. 

Page 15 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
15 
 
E. Describe how participant privacy, and if relevant – family privacy - will be protected during data collection if 
sensitive questions are included in interviews, or if study visits occur in the home setting.  
The survey questionnaire will not include culturally and individually sensitive questions. The enumerator will 
secure a quiet place in or near the residence of each study participant to ensure privacy, and to ensure distancing 
from other family members and neighborhoods.  The majority of information collected is focused on the 
household; individual information that is collected will be focused on care giver reports of child diet which is not 
sensitive. 
 
F. Levels of COVID-19 community transmission will vary considerably by geography and over time, and 
therefore, the responses to the pandemic may also vary.  The risk of COVID-19 to study staff and 
participants from in-person research activities can be mitigated by appropriate study procedures.  If you are 
conducting in-person research activities, please indicate the protections you plan to implement at your 
research site(s): 
 
☐   Not applicable 
☐   COVID testing of staff                                       
☐   COVID testing of study participants 
☐   Indoor masking/wearing PPE 
☐   Social distancing for indoor activities 
☒   Symptom screening of staff 
☐   Symptom screening of study participants 
☐   Vaccination of research team members 
☒   Other procedures/comments:   we follow Ethiopian COVID guidelines 
 
VIII. Direct Personal and Social Benefits: 
A. Describe any potential direct benefits the study offers to participants (“payment” for participation is not a 
direct personal benefit). 
All study participants benefit from the Ifaa project, however, there are no direct benefits to partipating in this 
evaluation.   
 
B. Describe potential societal benefits likely to derive from the research, including value of knowledge learned. 
 
Findings from this study will contribute to an understanding of multi-sectoral development programming in 
Ethiopia.  Knowledge learned will be applied by CRS in future programming and USAID in future funding calls for 
similar resilience programs.  
 
IX.  Payment or Token of Appreciation:   
A. Do you plan to provide a non-monetary token of appreciation (food, soap, tea, chlorine tablets, etc.) to study 
participants?  If no payment is provided, the JHSPH IRB strongly encourages providing such tokens. If yes, 
please describe below. 
We do not plan to provide non-monetary tokens of appreciation due to the fact that households are receiving 
Ifaa benefits. 
B. If you plan to provide a monetary payment, describe the form, amount, and schedule of payment to 
participants. Reimbursement for travel or other expenses is not “payment,” and if the study will reimburse, 
explain. 
 
We do not plan to provide monetary payment due to the fact that households are receiving Ifaa benefits. 
 

Page 16 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
16 
 
C. Include the possible total remuneration and any consequences for not completing all phases of the research. 
Not applicable 
 
X. Study Management: 
A. Oversight Plan: 
1. Describe how the study will be implemented.  List all parties, including collaborators and subcontractors, 
who will be “engaged” in the human subjects research project and their roles . 
The research will be led by a team from Johns Hopkins University (JHU) Department of International Health 
including Shannon Doocy, Yunhee Kang, and Seifu Tadesse. Dr. Doocy will serve as the PI, Dr. Kang will lead on 
data quality monitoring and analysis, and Mr. Seifu Tadesse, who is based in Ethiopia, will be responsible for 
training, data collection oversight and serve as the primary liaison between CRS and the data collection firm.  The 
data collection firm will be jointly selected by CRS and JHU from a CRS list of pre-approved companies that have 
performed similar work for CRS previously.  The data collection firm will be responsible for hiring enumerators 
which will have direct contact with study participants. 
Prior to and during each phase of data collection, the team will have regular calls to ensure adequate coordination 
and progress; in addition regular data quality monitoring and email correspondence will be used as a means of 
communication during data collection. Following the training of survey teams, quantitative baseline data 
collection will be conducted at the participants' households using Tablets/smartphones on the KOBO data 
platform. The baseline survey planning and logistics, and participant recruitment and data collection is planned to 
occur in May 2023. Following the two years of Ifaa intervention, JHU endline data collection will occur in May 
2025, and will follow a similar process as baseline. 
A training protocol will be designed by the JHU study team which will be delivered over a several day period to 
data collectors prior to each round of data collection.  The training will be led by Seifu Tadesse and supervisors 
from the local data collection firm. The training elements will include an overview of the study rationale, 
objectives, protocol, review of the quantitative tool, interviewing techniques, field survey procedures, field 
organization, quality control measures and IRB protocols, to ensure safety, confidentiality, and consent 
procedures.  Training will include content based on the JHSPH IRB Field Guide and also be specifically tailored to 
the questionnaire content. As part of the training, a field test will be conducted to give enumerators the 
opportunity to practice the consent process and interviews; following the field test modifications may be made 
to further tailor the questionnaire to the context (during the baseline survey only).   
At each round of data collection, enumerators will be directly supervised by a team leader with experience 
conducting surveys.  Data collection will be co-supervised by the data collection firm (using their usual practices) 
with additional on-the-ground support from Mr. Seifu Tadesse along with remote data quality monitoring 
managed by Dr. Kang.   
2. What are the qualifications of study personnel implementing the project? 
Dr. Doocy (PI) is internationally recognized for conducting research to improve international humanitarian 
response. She has twenty years of experience working in partnership with humanitarian agencies in the areas of 
health systems and health service delivery, food security, nutrition and cash transfers. Dr. Doocy has conducted 
research and evaluations in a diverse range of humanitarian settings, including naturals disasters and conflict, in 
Asia, Africa, the Middle East, Europe and Latin America. She has worked with numerous UN agencies including 
UNHCR, WFP, WHO, UNICEF and UNFPA in addition to various NGOs, governments, universities and international 
organizations. Her research and professional practice work centers on informing ongoing humanitarian health 
programs and responses, with the longer-term objective of expanding the evidence base to improve humanitarian 
policy and practice. Dr. Doocy has over 100 peer-reviewed articles on humanitarian emergencies and response 
and is involved in numerous humanitarian health committees and advisory groups. In addition to research and 
practice, Dr. Doocy teaches and administers academic programs in health systems and humanitarian health and 
has expertise in training and capacity development of global health professionals.                              

Page 17 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
17 
 
Yunhee Kang (Co-PI, data manager/analyst), Ph.D. is Assistant Scientist at the Department of International Health 
at the Johns Hopkins. She earned a Ph.D. degree in international nutrition from the Johns Hopkins School of Public 
Health. Her research interests include maternal and child health and nutrition, dietary assessment, food security 
and livelihoods, and impact and process evaluations of nutrition-sensitive programs. With more than 13 years of 
experience in field operations, she led or supported effectiveness/impact evaluation studies of large-scale, 
community-based health and nutrition projects in low-income settings. She conducted numerous population-
based epidemiological research studies related to undernutrition/overnutrition, dietary quality, food security, 
food system, and the impact of COVID-19 on income change and livelihoods in collaboration with UN agencies 
and international NGOs.  
Seifu Tadesse (Co-PI, responsible for data collection oversight), BA, MPH, is Mr. Seifu Tadesse is international 
research and M&E experts with more than 15 years’ experience in Africa.  He worked as Research Technical 
Managers, Research Team Leader, Principal Investigator (PI), and Qualitative and Quantitative researcher. He has 
concrete professional experience in research designing and implementation, prepare research qualitative and 
quantitative tools and research guidelines and organize and facilitate research capacity building training, provided 
routine technical support in data quality assurance. He involved in preparing research sampling framework, 
prepare research proposal, and involved in qualitative and quantitative data collection, data analysis and prepare 
report. Seifu has involved in research of multi-sectorial programs such as socio economic, livelihood, health, and 
education program studies and evaluations. He involved in the research and evaluations funded by World Bank, 
DFID, USAID, EU, Irish Aid, Canada CIDA. Also worked with WFP, UNICEF, INGO, and Government organizations in 
Ethiopia and other African Countries such as Zambia, Cameroon, Mali, and Lesotho.  Seifu holds Master in 
Monitoring and Evaluation, Bachelor of Arts with Honors in Development Studies; and a Bachelor of Art in Business 
Management. 
3. How will non-professional personnel (data collectors) involved with the data collection and analysis be 
trained in human subjects research ethical protections?  (Use the JHSPH Ethics Field Training Guide 
available on the JHSPH IRB website. If the study is a clinical trial, consider using the JHSPH Good 
Clinical Practice (GCP) For Social and Behavioral Research Field Guide).  
Data collectors will be trained on basic principles and protocols of human subjects research, using information from 
the JHSPH Ethics field training guide.   
4. If the JHSPH PI is responsible for data collection and will not personally be on-site throughout the data 
collection process, provide details about PI site visits, the supervision over consent and data collection, 
and the communication plan between the PI and study team. 
 
The JHU PI and Co-Is will have oversight over the data collection process. As the data will be collected through an 
online platform, JHU will have full access to the data entry and management platform. JHU team member Mr. 
Seifu Tadesse is based in Ethiopia and will be responsible for interviewer training and management of the data 
collection process.  Mr. Tadesse and Dr. Doocy have calls several times a week and regularly communicate via 
email.  Dr. Doocy does not have site visits planned explicitly for this study, however, she regularly travels to 
Ethiopia for the Ifaa Project with her travel scheduled planned around maximizing the utility of visits across 
multiple ongoing Ifaa studies.  
    B. 
Protocol Compliance and Recordkeeping:   
Describe how you plan to ensure that the study team follows the protocol and properly records and stores 
study data collection forms, IRB regulatory correspondence, and other study documentation (for assistance, 
contact:  [housecalls@jhu.edu]). 
Please provide information about study oversight to ensure compliance with IRB approval and regulatory 
and institutional requirements.  If the study team does not follow study procedure, what is your plan for 
reporting protocol non-compliance?   
Any reported breech of data protocols and non-compliance with IRB will be immediately addressed by the JHU 
research team and corrected or the individual study team member removed from the study. 
 

Page 18 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
18 
 
C.  Safety Monitoring: 
1. Describe how participant safety will be monitored as the study progresses, by whom, and how often.  
Will there be a medical monitor on site?  If yes, who will serve in that role and what is that person’s 
specific charge? 
N/A      
2. If a Data Safety Monitoring Board (DSMB), or equivalent will be established, describe the following: 
a.   The DSMB membership, affiliation and expertise. 
N/A     
b. The charge or charter to the DSMB. 
N/A      
c.   Plans for providing DSMB reports to the IRB. 
N/A      
3. Describe plans for interim analysis and stopping rules, if any. 
N/A      
 
D. Reporting Unanticipated Problems/Adverse Events (AEs) to the IRB (all studies must complete this 
section):   
 
NOTE: The IRB does not require PROMPT reporting of all AEs, only those that are unanticipated, pose 
risk of harm to participants or others, and are related to the study.  Anticipated AEs may be reported 
with the Continuing Review/Progress Report. 
 
Describe your plan for reporting to the JHSPH IRB, local IRBs, and (if applicable) to the sponsor.  Include 
your plan for government-mandated reporting of child abuse or illegal activity.  
The data teams will be trained on the JHU human subjects research guidelines, confidentiality, safety and 
protection. They will also receive training on appropriate child protection guidelines required by CRS Ethiopia. 
E.  Other IRBs/Ethics Review Boards:   
If other IRBs will review the research, provide the name of each IRB/ethics review board and its Federal 
Wide Assurance number, if it has one (available on [OHRP's Website]).  For federally funded studies, 
subrecipients  MUST have a Federal Wide Assurance (FWA) number from the OHRP.  The IRB 
overseeing the subrecipient should be registered with the OHRP.  The JHSPH IRB will not have 
oversight responsibility for international subrecipients, and generally will not oversee data 
collection at external U.S. institutions  Please contact the [JHSPH IRB Office] with questions. 
 
 
F. “Engaged” in Human Subjects Research:  
For studies that involve collaboration with non-JHSPH institutions, complete the chart below by describing 
the collaboration and the roles and responsibilities of each partner, including the JHSPH investigator.  This 
information helps us determine what IRB oversight is required for each party. Complete the chart for all 
multi-collaborator studies. 
 
Non-JHSPH  IRB/REC 
FWA Number 
Oromia Regional Administration (local authority) 
 
18852 
Ethiopia Public Health Association 
19561 

Page 19 of 19 
 
JHU IRB Protocol 23765 – Ifaa Effectiveness Evaluation (Version 4, 12 Jun 23) 
 
19 
 
Insert collaborator names and FWA numbers, if available.  Note who will be “engaged” in human 
subjects research by filling in the following table: 
 
JHSPH 
Local Data 
Collection Firm 
CRS 
For federally funded studies, collaborators’ FWA 
00000287 
 
00027851 
Primary Grant/Contract Recipient 
 
 
X 
Grant/Contract Subrecipient 
X 
X 
 
Hiring Data Collectors 
 
X 
X 
Training Data Collectors 
X 
X 
 
Obtaining Informed Consent and/or Identifiable Data 
 
X 
 
Accessing/Analyzing Identifiable Data 
X 
 
 
Overseeing storage, access and use of biospecimens 
N/A 
N/A 
N/A 
 
COMPLETE THE FOLLOWING SECTIONS WHEN RELEVANT TO YOUR STUDY: none are relevant  
 
 
REFERENCES 
 
i https://reports.unocha.org/en/country/ethiopia/card/1THC27CGy6/ 
ii Ethiopian Public Health Institute (EPHI) [Ethiopia] and ICF. 2021. Ethiopia Mini Demographic and Health Survey 2019: Final Report. 
Rockville, Maryland, USA: EPHI and ICF. 
iii Capacity4dev | Connecting the Development Community (europa.eu) 
iv Berhane G, Hoddinott J, and Kumar, N. (2017). The impact of Ethiopia’s Productive Safety Net Programme on the nutritional status 
of children: 2008–2012. ESSP Working Paper 99. Washington, D.C. and Addis Ababa: International Food Policy Research Institute 
(IFPRI) and Ethiopian Development Research Institute (EDRI). http://ebrary.ifpri.org/cdm/ref/collection/p15738coll2/id/131051 
v Berhane, G, Hoddinott J, Kumar N, et al. (2011) ‘Evaluation of Ethiopia’s Food Security Program: Documenting Progress in the 
Implementation of the Productive Safety Nets Programme and the Household Asset Building Programme’. Mimeo, Washington, 
D.C: International Food Policy Research Institute.