№ lp_2_3_22622
File format: docx
Character count: 8913
File size: 69 KB
Informed consent and authorization document outlining conditions for collecting and disclosing medical information about a pregnancy and infant health when the biological father participates in a clinical research study involving an investigational drug.
Institution:
The University of Toledo
Document Type:
Informed Consent Form and HIPAA Authorization
Study Context:
Pregnancy occurring while male partner participates in a research study
Principal Investigator:
Not specified
Sponsor:
Not specified
Regulatory Authorities Referenced:
U.S. Food and Drug Administration (FDA); Department of Health and Human Services (DHHS)
Ethical Oversight:
The University of Toledo Institutional Review Boards
Purpose:
Collection of medical information regarding pregnancy, outcome, and infant health
Data Subjects:
Pregnant partner and newborn child
Compensation:
None for participant
Costs:
No cost for data collection; routine medical care billed as usual
Confidentiality Scope:
Use and disclosure of protected health information
Authorization Expiration:
When the child reaches age 18 unless revoked earlier
Geographic Scope:
United States with possible international data transfer
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2025
Region / city:
Global
Topic:
Vaccine Policy, Maternal Health, Group B Streptococcus
Document type:
WHO Guidance
Institution:
World Health Organization (WHO)
Author:
WHO ECVP
Target audience:
Policymakers, Vaccine Developers, Public Health Authorities
Period of validity:
Ongoing
Approval date:
March 11, 2025
Date of changes:
Not specified
Year:
2020
Region / city:
Europe
Topic:
Pharmacovigilance, Pregnant and breastfeeding women
Document type:
Consultation comments
Organization:
EFPIA
Target audience:
Healthcare professionals, Regulatory authorities
Period of validity:
Ongoing
Approval date:
28th February 2020
Date of changes:
N/A
Context:
Comments on the European Medicines Agency (EMA) guidelines for pharmacovigilance regarding pregnant and breastfeeding women, focusing on clarifications and additional guidance in the document.
Year:
2004
Region / City:
Fort Myers, FL
Subject:
Cardiac anesthesia and perfusion techniques for pregnant patients
Document Type:
Clinical guideline
Institution:
Perfusion.com
Author:
Lynch BV, Brown DM
Target Audience:
Healthcare professionals involved in the care of pregnant patients needing cardiopulmonary bypass
Period of Validity:
Ongoing, review as changes occur
Approval Date:
Not specified
Date of Revision:
Not specified
Year:
2024
Region / City:
Massachusetts
Topic:
Public expenditure process, temporary housing assistance
Document Type:
Policy Document
Agency / Institution:
Executive Office of Housing and Livable Communities (EOHLC)
Author:
Commonwealth of Massachusetts
Target Audience:
Government entities, healthcare providers, social service agencies
Period of Effect:
From September 30, 2024, onwards
Approval Date:
September 30, 2024
Amendment Date:
Not specified
Note:
Year
Topic:
Research Consent
Document Type:
Informed Consent Form
Target Audience:
Pregnant Partner of Study Participants
Year:
2022
Region / city:
Hajjah Governorate, Yemen
Theme:
Malnutrition, Emergency Aid, Food Security, Humanitarian Crisis
Document Type:
Performance Report
Organization / Institution:
Sand Organization for Relief and Development (SORD)
Author:
Muhammad Abu Haider
Target Audience:
Humanitarian Workers, Donors, Government Agencies, NGOs
Period of Validity:
October 2022 - November 2022
Approval Date:
October 2022
Amendment Date:
N/A
Year:
2021
Region / City:
Texas
Topic:
Medicaid, Case Management, Healthcare Services
Document Type:
Draft Policy
Agency / Institution:
Health and Human Services Commission (HHSC)
Author:
Texas Health and Human Services Commission
Target Audience:
Healthcare Providers, Medicaid Recipients, Policy Stakeholders
Effective Period:
Indefinite
Approval Date:
Pending Public Comment
Modification Date:
N/A
Year:
2018
Region / City:
Massachusetts
Topic:
Pregnancy Accommodation, Employee Rights
Document Type:
Policy
Organ / Institution:
Human Resources Division, Commonwealth of Massachusetts
Author:
Human Resources Division
Target Audience:
Pregnant Employees, Prospective Employees
Effective Period:
From March 2018
Approval Date:
March 2018
Date of Changes:
March 2018
Note:
Contextual Description
Year:
2018
Region / City:
Commonwealth of Massachusetts
Topic:
Pregnancy accommodations for employees
Document type:
Policy
Organization / Institution:
Human Resources Division, Commonwealth of Massachusetts
Author:
Human Resources Division
Target Audience:
Pregnant employees and prospective employees
Effective period:
Not specified
Approval Date:
March 2018
Modification Date:
Not specified
Context:
A policy outlining the accommodation requirements for pregnant employees and job applicants in the Commonwealth of Massachusetts, including provisions for lactation and expressing breast milk.
Year:
2002
Region / City:
Cape Town, South Africa
Topic:
Maternal health, traditional medicine
Document Type:
Original research article
Institution:
South African Medical Research Council
Authors:
Naeemah Abrahams, Rachel Jewkes, Zodumo Mvo
Target Audience:
Health researchers, clinicians
Study Sites:
Two primary obstetric facilities and antenatal clinics of two secondary hospitals
Population:
Xhosa and Afrikaans speaking pregnant women
Keywords:
Indigenous healing practices, self-medication, pregnant women, South Africa, Dutch remedies
Year:
2021
Note:
Region / City
Subject:
Radiation Safety, Pregnancy Status Checks
Document Type:
Procedure
Target Audience:
Operators, Referrers, Radiology Staff
Year:
2024
Region / City:
United States
Topic:
Child Health Assistance, Medicaid, Continuous Eligibility
Document Type:
State Plan Page
Agency / Institution:
Centers for Medicare & Medicaid Services (CMS)
Author:
N/A
Target Audience:
State Medicaid and CHIP administrators
Period of Validity:
2024
Approval Date:
January 1, 2024
Date of Modifications:
N/A
Year:
2012
Region / City:
Mosul
Topic:
Anaemia in pregnancy
Document Type:
Research Study
Institution:
Nineveh Health Directorate, Al-Khansaa Educational Hospital, AL-Batool and AL-Khansaa Teaching Hospitals
Authors:
Ruqayah Youns Hasani, Sedra A Alnuamy, Duaa I Al Ahmed
Target Audience:
Health professionals, researchers, public health officials
Period of Study:
1st January 2012 – 1st July 2012
Date of Approval:
Not specified
Date of Modifications:
Not specified
Ethical Approval:
Yes, obtained from Nineveh Health Directorate and relevant hospitals
Keywords:
Anemia, pregnant women, Mosul, term pregnancy, iron deficiency
Year:
2026
Region / City:
United States
Subject:
Medical Research, Pregnancy, Clinical Trials
Document Type:
Informed Consent Form
Institution / Organization:
Weill Cornell Medicine Institutional Review Board
Principal Investigator:
[PI name]
Study Sponsor:
[study sponsor]
Target Audience:
Pregnant partners of study participants
Study Period:
During pregnancy and 30 days post-delivery
Document Version Date:
[Version date]
Data Usage:
Collection and analysis of health information for research purposes
Confidentiality Measures:
Data storage, limited access, de-identification, legal disclosures if required
Year:
2019
Region / City:
Uganda
Theme:
Stakeholder Engagement, Environmental Protection, Climate Change
Document Type:
Framework
Organization:
Ministry of Water and Environment
Author:
Ministry of Water and Environment
Target Audience:
Stakeholders, Government Agencies, Environmental Organizations
Effective Period:
October 2019 – January 2020
Approval Date:
20 December 2019
Date of Changes:
Not specified
Year:
2026
Region / City:
South Carolina
Theme:
Environmental Conservation
Document Type:
Legislation
Institution / Organization:
South Carolina General Assembly
Author:
General Assembly of the State of South Carolina
Target Audience:
State officials, environmental agencies, landowners
Period of Action:
2026-2050
Amendment Date:
N/A
Note:
Year
Topic:
Medical Research
Document Type:
Consent Form
Organization / Institution:
University of Utah
Target Audience:
Research Participants
Year:
2025
Region / City:
England and Wales
Subject:
Court orders, anonymity, legal procedures
Document Type:
Legal order
Organization / Institution:
Judiciary of England and Wales
Author:
[Not specified]
Target Audience:
Legal professionals, claimants, defendants, and others involved in legal proceedings
Effective Period:
Until the death of the claimant or protected person
Date of Approval:
[Not specified]
Date of Modifications:
[Not specified]
Note:
Year
Topic:
Debt management, Trust Deeds
Document Type:
Informational, Legal
Organ / Institution:
Citizens Advice Bureau, Money Advice Scotland
Target Audience:
Individuals facing debt issues