Blanket consent - “The safety blanket for research”
How to cite this article: Bhuvaneshwari NG, Savithramma RB, Nagesh L. Blanket consent - “The safety blanket for research”. J Global Oral Health, doi: 10.25259/JGOH_20_2022
Every individual has the right to make decisions concerning health. Informed consent covers only known uses of samples/models/specimens. Hence, that cannot be considered purely informed consent because of complexity of genetic information. Blanket consent implies that there are no restrictions to the scope and duration of the consent. Which is given only once, but includes consent for any use of the samples at any time in the future. It is particularly important for scientific research in which new projects or experiments might be devised years after the subjects have given their consent and deposited their specimens/models etc. However, there are chances of misuse of information/specimen and there may be a breach of privacy and confidentiality.
“Blanket Is Never A Blanket Until It Covers The Entire Body”
Research is essential for advancing medical and dental science knowledge. Because it is often useful in devising better treatment modalities, as well as in making policy suggestions. Like all kinds of medical and healthcare research, dental research also involves human subjects. Participants have the right to know entire details about it. Based on the ethical principle of respect for persons, the goal of informed consent is to ensure that subjects are aware of the risks and potential benefits, which enables them to make a voluntary decision about participating in the research. Informed consent usually covers the known or specific or planned uses of specimens or models or records obtained from patients. Informed consent is a cornerstone of the ethical conduct of research involving humans.
As advances in medicine, genetic, and genomic research are increasing, it has challenged the traditional conceptions of informed consent. Changes occur so fast in the field of medicine that the time required to reflect on ethical implications often seems to be too short. However, there can be situations, where the clinician treating the patient with a different clinical presentation may not be aware of new diagnostic aids, methods, techniques, etc., for assessment or management of the condition/patient at that moment. Storing interesting models/samples/records, etc., will enable them to conduct research with new tools or novel methodologies in the future. Therefore, newer concepts are desirable to offer robust moral guidance, while keeping the reality of the dynamics of ethics in mind. One such new concept is open blanket consent. Therefore, biological specimens, records, X-rays, models, etc., can be stored and used in the future for research. The consent for such future research could be obtained through blanket consent. It is consent that is given only once but covers any future use of the material. It is also called open, broad, generic, or blanket consent. Therefore, it prevents ethical issues regarding the usage of samples for research, which might not be planned when the consent was obtained. Perhaps, it is impossible to describe the details of forthcoming research for which those can be used, at the time of collection. In addition, the usage of such samples for which a new informed consent to be obtained from the subject at that time could considerably diminish the validity of a scientific study. It might introduce selection bias. Clayton et al. justify the use of blanket consent. First, practical difficulty to obtain consent for previously collected specimens. Second, he argues that blanket consent may cause very small or non-existent risks to those participants.
Further with the rapid advancement in technology, the future risks associated with research using biospecimens/models/ samples/records, etc., are unpredictable. Therefore, legal and ethical requirements of informed consent for all future uses cannot be satisfied at the time, such data are collected. Existing biological materials were allowed to be used for research without consent if they were deidentified. The organizations such as UNESCO and WHO have recommended the use of blanket consent for the data in biorepositories and genetic research in general. Other institutions and laws favoring blanket consent are as follows: (1) Council of Europe’s convention on human rights and biomedicine, (2) the Danish council of ethics, and (3) the national bioethics committees of various countries, such as the French national consultative ethics committee for health and life sciences (2003), and the German national ethics council (2004).
Greely proposed a variation on blanket consent which adds extra protection. His approaches involved informing subjects regarding method of storing their models/samples and an explanation regarding the possibilities for its use for the future research. The participants were given option whether to consent or not for the future use of the specimens/samples/ records, etc. Weir and Olick suggested a hybrid approach wherein the subjects would have provision to consent for the specific type of research study at the present. Regarding the future research, the subjects are given options to consent for studies that fell within certain categories or satisfied certain conditions. For example, subjects may consent to research on any known medical conditions, but not for studies related to genetic components research.
It allows multiple usage of the samples in the future, leads to the development of new diagnostics and therapy
In case of studies related to role of genes in complex diseases using advanced technology, assessing the sensitivity of new diagnostic aid against gold standard, checking the efficacy of various drugs, etc., helps in understanding the etiology of diseases and can lead to improved diagnostics, intervention, and treatment. These findings are anticipated to benefit the population at large through improved mortality, morbidity, workforce production, and decreased health expenditures.
It is advantageous for the researchers, as the cost and time-consuming recontact procedures are avoided
On an individual level, the practice of healthcare can move toward individualized medicine.
Inherently vague, as subjects would not know exactly what their records/samples will be used for in the future. It also appeals the generic risk of undermining the meaning of consent
Models/samples might be used in future studies that may conflict with individual interest/values; therefore, restrictions are essential.
That is, the researchers can again contact the participants, to obtain consent for additional use of their data/models/ samples. However, this may give the participants the thinking, of why only their specimen or data have been selected and also cause practical hurdles and expenses. This, in turn, may have an adverse impact on study validity due to non-response and loss of follow-up.[2,6] Hence, it can potentially undermine the value of research with such samples.
Misuse of information such as invalidated research results can cause anxiety and stress. In turn, it could lead to stigmatization, psychological harm, or insurance discrimination against the participant. Although the capacity to identify an individual’s details among the collective dataset is limited, but with the hasty technological advancements, there lies a constant prospect of unforeseen risks
Breach in confidentiality
It cannot be guaranteed.
Bio-specimen/models/records collections should state the procedures clearly for protecting the participant’s personal information. The procedures include data encryption, coding, establishing limited access, use of non-disclosure agreements, and use of an honest broker system.
Option for withdrawal
Commercial use of research derivatives
Participants should be informed about any costs or payments associated with participation, as well as the possibility that the research could lead to the development of commercial products. Furthermore, regarding the allocation of profits generated if any from such products.
TEMPLATE FOR BLANKET CONSENT
The aim of the present review was to propose a template for blanket consent thorough literature exploration. Only PubMed indexed full text articles available in English language from January 01, 2011, to December 31, 2021, highlighting blanket consent were searched. Articles published in any other language, only abstracts, and other types were excluded from the study. Search criteria (Blanket [All Fields] AND consent [All Fields] AND pro forma [All Fields]) AND (“2011/01/01”[PubDate]: “2021/12/31”[PubDate]).
RESULTS AND DISCUSSION
The results of a PubMed search revealed 33 articles, but on thorough screening, results showed that there is no specific pro forma related to blanket consent. Considering the necessity for informed consent for biological specimens’/ samples/models/X-rays storage and usage a blanket consent form must be prepared and consented by the participants for reuse of their samples. An attempt has been made to prepare a consent form. A template for the blanket consent form has been designed by considering the points and format as given by the WHO research ethics review committee. The researcher can adapt their blanket consent form according to the necessities of their study. The form consists of two parts, that is, the participant information and consent form. Two separate forms need to be prepared for literates and illiterates, to enable the subjects to voluntarily consent. The form should be printed on the respected institution/research center letterhead along with the logo [Section 1 and 2].
Blanket consent for future studies can be considered valid, provided the personal information of research participants is handled safely. Participants should be allowed to withdraw consent at any time, and every study should be reviewed by the ethical review board. The committee must determine the following requirements. The research is of general interest, there is no explicit objection to the research and the confidentiality of individual information is safeguarded.
Declaration of patient consent
Patient’s consent not required as there are no patients in this study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
BLANKET CONSENT SAMPLE PROFORMA
We are hereby seeking permission to store your unused samples/models/cephalograms etc. for possible future use in either your own research or someone else’s research. You are given full authority to make decisions whether the researchers can keep the sample retaining all the information or should deidentify the sample information. Furthermore, the samples will be used for research which have received an ethical committee approval and will not be sold for profit.
Right to Refuse and Withdraw
You may refuse/allow the samples storage or can restrict those samples from being used more than once with no loss of benefits. You may withdraw permission at any time in the future and provide them with the name, address, and number of the person and sponsoring institution to contact.
We assure you that confidentiality will be maintained including any limitations.
Certificate of Consent
If any of the (MENTION THE TYPE OF SAMPLE, i.e., blood, tissue, records, and models) sample that I have provided for this research project is unused or leftover when the project is completed
(Tick one choice from each of the following boxes)
Destroy my [MENTION THE TYPE OF SAMPLE] immediately. Destroy my [MENTION THE TYPE OF SAMPLE] after ____ years. I give permission for my [MENTION THE TYPE OF SAMPLE] sample to be stored indefinitely
Destroy my [MENTION THE TYPE OF SAMPLE] immediately.
Destroy my [MENTION THE TYPE OF SAMPLE] after ____ years.
I give permission for my [MENTION THE TYPE OF SAMPLE] sample to be stored indefinitely
(Tick one choice from the following boxes, if you permit to store your sample)
I give permission for my (MENTION THE TYPE OF SAMPLE) sample to be stored and used in future research but only on the same topic as the current research project: [give name of current research] I give my permission for my [MENTION THE TYPE OF SAMPLE] sample to be stored and used in future research of any type which has been approved by ethical committee I give permission for my [MENTION THE TYPE OF SAMPLE] sample to be stored and used in future research except for research about [NAME TYPE OF RESEARCH].
I give permission for my (MENTION THE TYPE OF SAMPLE) sample to be stored and used in future research but only on the same topic as the current research project: [give name of current research]
I give my permission for my [MENTION THE TYPE OF SAMPLE] sample to be stored and used in future research of any type which has been approved by ethical committee
I give permission for my [MENTION THE TYPE OF SAMPLE] sample to be stored and used in future research except for research about [NAME TYPE OF RESEARCH].
Remove my identity from (MENTION THE TYPE OF SAMPLE) sample I permit to retain my identity with my (MENTION THE TYPE OF SAMPLE) sample.
Remove my identity from (MENTION THE TYPE OF SAMPLE) sample
I permit to retain my identity with my (MENTION THE TYPE OF SAMPLE) sample.
I have read the information and I consent voluntarily to have my samples stored in the manner and for the purpose indicated above.
A literate witness will be asked to sign (this person should be selected by the participant and should have no connection to the research team).
I have witnessed the accurate reading of the consent form to the potential participant, and I confirm that the individual has given consent freely.
Name of witness ______________ Thumb print of participant
Signature of witness ______________________
Undertaking by the Researcher
To the best of my ability, it will be made sure that participants understand the following.
Samples may be used for future similar, or different research in different settings The participant has the right to withdraw the consent at any time Confidentiality will be maintained and the samples will not be misused.
Samples may be used for future similar, or different research in different settings
The participant has the right to withdraw the consent at any time
Confidentiality will be maintained and the samples will not be misused.
We hereby confirm that the participant was provided with all the information regarding the future use of the sample and was given opportunity to clarify about the manner of storage of the collected/received samples. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.
(A copy of this form has been provided to the participant).
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