Evaluating the validity of adherence measurement methods for Multiple Micronutrient Supplementations (MMS) among pregnant women in Ethiopia: comparing self-reports and pill counts

FWA #00000287 Approval-Determination Template V11_Mar2024 Institutional Review Board Office Phone: 410-955-3193 Toll Free: 1-888-262-3242 Email: [email protected] Website: www.bsph.edu/irb APPROVAL/DETERMINATION MEMO INITIAL APPLICATION Date: July 2, 2024 To: Maria Elena Figueroa, PhD Department of Health, Behavior & Society From: Anna Durbin, MD Chair, IRBFC Study Title: “Evaluation of prototype solutions for optimizing IFA or MMS adherence among pregnant women and adolescent girls in Ethiopia” IRB No.: 24717 Approved Approved, minor change (single reviewer) Approved Expedited Cat: Determined to be Exempt Cat: Approval/Determination Date: May 8, 2024 Approval Lapse Date: May 7, 2025 As Principal Investigator for this IRB approved study, you are responsible for conducting the study in accordance with the ethical principles of the Belmont Report, in compliance with all relevant laws and regulations, and in accordance with JHU institutional policy. Your approval will LAPSE on May 7, 2025. This means you cannot perform study activities after this date without an approved progress report. If you submit less than 1 week before the lapse date, the IRB may not be able to review your report and process an approval in time to avoid a lapse. We recommend that you submit a progress report 6 weeks before the approval lapse date to avoid an interruption to your research operations. This approval is inclusive of the following documentation: Research Plan: • Ethiopia IFA-MMS Research Plan (PI version #1, June 27, 2024) Approval-Determination Template V11_Mar2024 Consent/Parental Permission/Assent Form(s): • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version #1, April 26, 2024) • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Amh) • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Ben) • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Ged) • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Gur) • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Had) • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Kef) • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Sid) • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Sil) • Informed Consent Form – Ethiopia Consent IDI Adult Pregnant Women; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Wol) • Informed Consent Form - Ethiopia IFA-MMS Consent Adult Quantitative Baseline (PI version#1, April 26, 2024) • Informed Consent Form – Ethiopia IFA-MMS Consent Adult Quantitative Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Amh) • Informed Consent Form – Ethiopia IFA-MMS Consent Adult Quantitative Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Ben) • Informed Consent Form – Ethiopia IFA-MMS Consent Adult Quantitative Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Ged) • Informed Consent Form – Ethiopia IFA-MMS Consent Adult Quantitative Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Gur) • Informed Consent Form – Ethiopia IFA-MMS Consent Adult Quantitative Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Had) • Informed Consent Form – Ethiopia IFA-MMS Consent Adult Quantitative Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Kef) • Informed Consent Form – Ethiopia IFA-MMS Consent Adult Quantitative Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Sid) • Informed Consent Form – Ethiopia IFA-MMS Consent Adult Quantitative Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Sil) • Informed Consent Form – Ethiopia IFA-MMS Consent Adult Quantitative Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 – Wol) • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024) • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Amh) Approval-Determination Template V11_Mar2024 • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Ben) • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Ged) • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Gur) • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Had) • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Kef) • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 -Sid) • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Sil) • Informed Consent Form – Ethiopia IFA-MMS Consent – Adult KII Qualitative; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Wol) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Amh) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Ben) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 -Ged) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Gur) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Had) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 -Kef) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Sid) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Sil) • Informed Consent Form – Ethiopia Adult Consent Quantitative Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Wol) • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024) • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Amh) • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Ben) • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Ged) Approval-Determination Template V11_Mar2024 • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Gur) • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Had) • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Kef) • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Sid) • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Sil) • Parental Permission – Ethiopia Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Wol) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024 – Amh) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024 - Ben) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024 - Ged) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024 - Gur) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024 -Had) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024 - Kef) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024 - Sid) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024 - Sil) • Parental Permission – Ethiopia Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26. 2024 - Wol) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Amh) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Ben) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Ged) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Gur) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Had) Approval-Determination Template V11_Mar2024 • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Kef) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Sid) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Sil) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Baseline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Wol) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Amh) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Ben) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Ged) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Gur) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 -Had) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Kef) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Sid) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Sil) • Assent Form – Ethiopia Assent Adolescent Pregnant Women Endline; IRB approval date; May 8, 2024; (PI version#1, April 26, 2024 - Wol) Recruitment Material: • Ethiopia FIA-MMS Recruitment Script – KII Qualitative; IRB approval date; May 8, 2024; (PI version #1, March 23, 2024) • Ethiopia IFA-MMS Recruitment Script – Pregnant Women Quantitative; IRB approval date; May 8, 2024; (PI version#1, March 24, 2024) • Ethiopia Recruitment Script – Pregnant Women IDI; IRB approval date; May 8, 2024; (PI version#1, March 19, 2024) Instruments: • Form 1; Monitoring Tracking Sheets and Checklist; • Form 2; Supportive Supervision and Monitoring Tracking and Checklist; • Ethiopia IFA-MMS IDI PW; (PI version#1, March 26, 2024) • Ethiopia IFA-MMS KII Guide HDAs; (PI version#1, March 25, 2024) • Ethiopia IFA-MMS KII Guides HEWs Midwives Nurses; (PI version#1, March 25, 2024) Approval-Determination Template V11_Mar2024 • Ethiopia IFA-MMS KII Guides PHCU MCH; (PI version#1, March 25, 2024) • Women Questionnaire IFA MMS; (March 28, 2024) *DHHS 45 CFR 46 CR Revised CR FDA 21 CFR 50, 56 IND, 21 CFR 312 IDE, 21 CFR 812 IND/IDE held by BSPH PI Dept. of Defense Funding Min. Risk Greater than min. risk GWAS Reliance Agreement Clinical Trial/GCP *Study Site(s): U.S. International *List Country(ies): Ethiopia *Consent/Parental Permission Required From: Adult Participant LAR One Parent Two Parents 46.406, 50.53 Legal Guardian of Children in Foster Care Minor Consent as Adult *Vulnerable Populations: Children Foster Care Children DHHS FDA 46.404 50.51 46.405 50.52 46.406 50.53 Preg. Women/Fetuses 46.204 Neonates Prisoners *Adult Consent: Written Consent Waiver of Signature Exempt (Electronic) Alteration of Consent; meets 46.116 (f)(3) criteria Waiver of Informed Consent; meets 46.116 (f)(3) criteria *Assent: Written (signed) Oral Statement in Parent Permission Form Electronic Waived for all children Waived for children *HIPAA: JHM Non-JHM Authorization Prep. To Research HIPAA Alteration/Waiver JHM Data Tracking Limited Data Set DUA *Parental Permission: Written Permission Waiver of Signature Exempt (Electronic) Alteration of Permission; meets 46.116 (f)(3) criteria Waiver of Permission; Meets 46.116 (f)(3) 46.408, with Substitute Mechanism provided *Sample Size: (screened plus enrolled) 5,096 *Final Enrollment: *Secondary Data Analysis: (specimens/participants) *Complete for Exempt Studies for operational purposes to help track documents; HSR code provisions do not apply. As Principal Investigator of IRB approved research, you are responsible for meeting the following requirements of approval: 1) Informing the co-investigators listed on the application of the status of the research. 2) Submitting an Amendment Application or Administrative Amendment for any changes in research. These changes in research are required to be reviewed and approved prior to the activation of the changes unless you are correcting or clarifying language in approved instruments. 3) Reporting Unanticipated problems involving risk of harm to participants or others that are related to the study procedures to the BSPH IRB within 10 days of the time that the PI learns of such problems. A Problem Event Report Form must be submitted to the IRB immediately. 4) Using only the most recently approved BSPH IRB approved consent forms, with the BSPH stamp or logo, unless otherwise approved by the IRB. All consent forms signed by subjects enrolled in the study should be stored securely, in paper or electronic form, until 3 years following study completion unless otherwise approved by the IRB. Approval-Determination Template V11_Mar2024 5) Submitting in a timely fashion Continuing Review Applications or Progress Reports. The Approval Lapse Date above marks the end of this approval; no study activity may take place after that date without new IRB approval. Submit your report to the IRB Office no later than six weeks prior to the approval lapse date to allow time for IRB review to be completed prior to that date. 6) If your study is an NIH funded clinical trial, e.g., “A research study in which one or more human participants 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”, it must be registered on clinicaltrials.gov, and one IRB approved consent form used in the study must be posted on a publicly available Federal website. 8) If your research involves a Reliance Agreement through which we are serving as the Reviewing IRB, you are responsible for informing the relying PI of the initial approval, and any amendment or continuing review approvals. AD/rch