Evidence map›Paper›PMID 28649317›Full record

ArticleBiology of sex differences2017

Inclusion of sex and gender in biomedical research: survey of clinical research proposed at the University of Pennsylvania.

Anne Freeman, Patrick Stanko, Lily N Berkowitz, Neanta Parnell, Anastasia Zuppe, Tracy L Bale, Tracy Ziolek, C Neill Epperson

Open access · goldAbstract read
In one paragraph

Article in Biology of sex differences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Sex and gender differences in cancer pathogenesis and pharmacology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
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  20. Sex and Gender Dimensions in Hazard and Risk Assessment of Engineered Nanomaterials.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Anne FreemanDepartment of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA USA.
Patrick StankoInstitutional Review Board, University of Pennsylvania, Philadelphia, PA USA.
Lily N BerkowitzDepartment of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA USA.
Neanta ParnellDepartment of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA USA.
Anastasia ZuppeDepartment of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA USA.
Tracy L BalePenn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, 3535 Market Street, Rm 3001, Philadelphia, PA 19104 USA.
Tracy ZiolekInstitutional Review Board, University of Pennsylvania, Philadelphia, PA USA.
C Neill EppersonDepartment of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA USA.ORCID 0000-0002-1010-1409
University of Pennsylvania · USAmerican Board of Internal Medicine · US

Funding

Prepubertal Stress, Windows of Risk & Sex Bias for Affective DisturbanceP50MH099910 · NIMH · UNIVERSITY OF PENNSYLVANIA · PI KIM, DEBORAH · 2012 to 2017
$6.5M
Training in Sex and Gender Differences Research to Improve Women's HealthK12HD085848 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI OQUENDO, MARIA A · 2015 to 2019
$2.2M
NICHD NIH HHS K12 HD085848NIMH NIH HHS P50 MH099910
6 · The paper itself

Abstract

backgroundThe 2015 National Institutes of Health (NIH) policy that sex be considered as a biological variable (SABV) is now a critical part of the peer-review process for NIH funding as well as publication in several high-impact scientific journals. We sought to determine the degree to which biomedical researchers at the University of Pennsylvania already consider SABV or gender in their research.

methodsWe reviewed 240 research protocols approved by the University of Pennsylvania Investigational Review Board (IRB) consecutively submitted between January and July 2016. Each protocol was searched for the terms sex, gender, male, female, man, and woman and justifications related to the population under study. A PubMed search was conducted to determine the current state of knowledge regarding potential sex and/or gender differences with respect to protocol topic. Data were summarized using descriptive statistics.

resultsOf the 165 (68.8%) protocols that included one of the search terms, only 24 (14.5%) provided justification for the choice of the sex/gender of the population studied. Sixty-three percent (

conclusionsReview of a subset of IRB protocols submitted at a major research institution suggests that very few investigators are considering sex or gender as important variables in their clinical research at the stage of protocol development. IRBs are in an excellent position to encourage investigators to consider SABV and gender in order to enhance the rigor of research design, maximize the importance of the resulting knowledge, and ensure that subject selection is equitable. These findings serve as the basis for developing an intervention at the level of IRB protocol development and submission that will promote consideration of SABV and/or gender, factors with critical import to patient safety and efficacy of interventions.

Indexed as

Sex CharacteristicsAnimalsBiomedical ResearchEthics Committees, ResearchHumansNational Institutes of Health (U.S.)Research DesignSex FactorsUnited StatesEthicsGenderInformed consentInstitutional review boardResearchSex

Identifiers

PMID28649317
PMCPMC5480171
OpenAlexW2634622749

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.