Evidence map›Paper›PMID 35206963›Full record

ReviewHealthcare (Basel, Switzerland)2022

Informed Consent and Protection of Personal Data in Genetic Research on COVID-19.

Piergiorgio Fedeli, Roberto Scendoni, Mariano Cingolani, Marcelo Corrales Compagnucci, Roberto Cirocchi, Nunzia Cannovo

Open access · goldAbstract readReview
In one paragraph

Review in Healthcare (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 23% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
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

6 authors at 4 institutions in 2 countries.

Piergiorgio FedeliShool of Law, University of Camerino, 62032 Camerino, Italy.ORCID 0000-0003-2287-2582
Roberto ScendoniDepartment of Law, University of Macerata, 62100 Macerata, Italy.
Mariano CingolaniDepartment of Law, University of Macerata, 62100 Macerata, Italy.ORCID 0000-0003-1916-1819
Marcelo Corrales CompagnucciCentre for Advanced Studies on Biomedical Innovation Law (CeBIL), Faculty of Law, University of Copenhagen, Karen Blixens Plads 16, DK-2300 Copenhagen, Denmark.ORCID 0000-0001-5709-3621
Roberto CirocchiDepartment of Surgical and Biomedical Sciences, University of Perugia, 06132 Perugia, Italy.ORCID 0000-0002-2457-0636
Nunzia CannovoEthic Committee, University of Naples, 80138 Napoli, Italy.
University of Macerata · ITUniversità di Camerino · ITUniversity of Copenhagen · DKUniversity of Perugia · IT

Funding

Novo Nordisk Foundation NNF17SA0027784)
6 · The paper itself

Abstract

The particular characteristics of COVID-19 demand the careful biomedical study of samples from patients who have shown different symptomatology, in order to understand the genetic foundations of its phenotypic expression. Research on genetic material from COVID-19 patients is indispensable for understanding the biological bases for its varied clinical manifestations. The issue of "informed consent" constitutes the crux of the problem in regulating research biobanks, because it concerns the relationship between the person and the parts separated from the body. There are several consensus models that can be adopted, varying from quite restricted models of specific informed consent to forms that allow very broad authorization (open consent). Our current understanding of COVID-19 is incomplete. Thus, we cannot plan, with precision, the research to be conducted on biological samples that have been, or will be, collected from patients infected by the novel coronavirus. Therefore, we suggest utilizing the "participation pact" between researchers and donors, based on a new form of participation in research, which offers a choice based on the principles of solidarity and reciprocity, which represent the communication of "values". In the last part of this paper, the general data protection regulation concerning the matter is discussed. The treatment of personal data must be performed with explicit goals, and donors must be provided with a clear, transparent explanation of the methods, goals and time of storage. The data must not be provided to unauthorized subjects. In conclusion, open informed consent forms will be necessary for research on individual patients and on populations.

Indexed as

biobanksCOVID-19 infectiongeneral data protectiongenetic factorsphenotypic expressionregulation informed consent

Identifiers

PMID35206963
PMCPMC8871888
OpenAlexW4212896176

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.