FAQ
Contents
- 1 About the quality system in general
- 1.1 Can I appoint my student or postdoc to be the Process Owner for the EQIPD Quality System in my lab (group, department, institute)?
- 1.2 Contract Research Organizations (CROs) often do not know the purpose of research. How can they state in the study plan whether a study is to inform a formal knowledge claim or not?
- 1.3 If a study involves a series of independently performed experimental procedures, assessments and analyses, should they all be conducted with the same level of research rigor?
- 1.4 How could small organizations (especially those operating virtually) fulfill the core requirement on Responsible conduct of research?
- 1.5 In our laboratory, hand-written notes taken during the experiments are scanned and PDFs are then stored electronically. We treat these scanned copies as raw data and discard the paper originals. Is such practice acceptable?
- 1.6 We have a number of internal documents (templates, policies, procedures) written in a non-English language. Should these be translated?
- 1.7 We have a number of internal documents that, according to an internal policy, cannot be sent or taken outside of our organization. Will that prevent us from getting an EQIPD Quality System accreditation?
- 2 Specifically about knowledge-claiming research
- 2.1 Contract Research Organizations (CROs) often do not know the purpose of research. How can they state in the study plan whether a study is to inform a formal knowledge claim or not?
- 2.2 Are PK, bioanalysis and other “quantitative” studies in pharmacology informing a formal knowledge claim?
- 2.3 Would EQIPD external or internal assessment experts need to judge which study belongs to the “knowledge claim” category and which not?
About the quality system in general
Can I appoint my student or postdoc to be the Process Owner for the EQIPD Quality System in my lab (group, department, institute)?
As explained in the corresponding Toolbox section, the Process owner should be competent and should have sufficient control of resources. Certain tasks and functions can be delegated by the Process Owner to appropriate people in the research unit but the overall responsibility should stay with the competent (senior) person with relevant knowledge and access to resources (person that will likely remain in the research unit for a long time).
Contract Research Organizations (CROs) often do not know the purpose of research. How can they state in the study plan whether a study is to inform a formal knowledge claim or not?
If sponsor of a study does not provide such information or is not willing to have this information to be included in the study plan, then the "knowledge-claiming research" box should not be ticked. It is nevertheless expected that the study plan includes information about any and all measures taken to protect against the risks of bias. For all research, EQIPD recommends to apply maximal possible rigor.
If a study involves a series of independently performed experimental procedures, assessments and analyses, should they all be conducted with the same level of research rigor?
There is no such requirement. The only expectation is that, for every individual experiment, procedure or analysis, risks of bias are assessed and protective measures are transparently reported.
How could small organizations (especially those operating virtually) fulfill the core requirement on Responsible conduct of research?
It may indeed be not possible in some cases to identify a person of trust or set up an anonymous mailbox or a confidential electronic "hotline" within the organization. from where concerns are triaged to a dedicated person. In such situations, EQIPD advises to look for alternative solutions - a person of trust in the neighboring research unit or organization; a member of the advisory board; a representative of the funders or investors; a member of the IACUC or animal welfare body reviewing the in vivo work in the research unit. Even small biotech or CROs do not operate in complete isolation and one may only be advised to look around and identify individual(s) who would be willing to support research integrity efforts of the research unit and who would be in a position to deal with violations and allegations of misconduct in agreement with the national or institutional guidelines.
In our laboratory, hand-written notes taken during the experiments are scanned and PDFs are then stored electronically. We treat these scanned copies as raw data and discard the paper originals. Is such practice acceptable?
If it is not possible to maintain both paper-based and electronic archive (laboratory notebook), then such practice is acceptable. Of course, such copies should be complete and of good quality.
We have a number of internal documents (templates, policies, procedures) written in a non-English language. Should these be translated?
No, there is no need to translate. You can make references to these internal documents, for example, in the Documentation Plan, etc. If you decide to conduct an external assessment of the Quality System performance (e.g. for accreditation purposes), EQIPD experts will read in the original language or have it translated into English.
We have a number of internal documents that, according to an internal policy, cannot be sent or taken outside of our organization. Will that prevent us from getting an EQIPD Quality System accreditation?
No, albeit this creates some inconvenience, this is not a roadblock. Should these documents be seen by EQIPD experts as essential, this increases a probability that your research unit is chosen for onsite visit (rather being assessed remotely).
Specifically about knowledge-claiming research
Contract Research Organizations (CROs) often do not know the purpose of research. How can they state in the study plan whether a study is to inform a formal knowledge claim or not?
If sponsor of a study does not provide such information or is not willing to have this information to be included in the study plan, then the "knowledge-claiming research" box should not be ticked. It is nevertheless expected that the study plan includes information about any and all measures taken to protect against the risks of bias. For all research, EQIPD recommends to apply maximal possible rigor.
Are PK, bioanalysis and other “quantitative” studies in pharmacology informing a formal knowledge claim?
Such studies often lack a “hypothesis” (scientific or statistical) but a “hypothesis” is not a requirement for “knowledge claim” studies. Thus, such studies may indeed be declared as research to inform a knowledge claim if the scientists decide so and apply maximal possible rigor.
Would EQIPD external or internal assessment experts need to judge which study belongs to the “knowledge claim” category and which not?
No, definitely NOT. EQIPD requests that the scientists themselves declare before doing a study whether it is intended to inform a knowledge claim or not. And it is the scientists themselves who conduct a risk assessment and decide what research rigor measures should be applied. The job of internal or external assessors is only to confirm that experimental process and reporting are transparent. Let us assume I have no a priori intention for a knowledge claim when I plan my work. Nevertheless, I do the study(ies) under full rigor. Can I still make a knowledge claim after the studies are completed?EQIPD does recognize this example as highly relevant because there are indeed situations when, for example, a need to use the research resulrs to justify a certain decision is not evident when a study is planned. There are two ways to look at such situation. On the one hand, in the end of the day, it is the research rigor that matters and not just the name of “knowledge-claiming research”. Therefore, in principle, all studies conducted under maximal possible rigor can support decision making, build confidence, etc., whether "knonwledge claim" was prespecified or not. However, if prespecified, studies must be conducted under maximal rigor or no such claim is possible. If, for some reason, there is a deviation from the pre-specified research rigor conditions during the course of the study, it needs to be clarified in the study report and the “knowledge claim” may no longer be valid. On the other hand, EQIPD stongly advises all EQIPD QS-compliant research units to declare the "knowledge claiming research" in ALL cases when studies are planned with maximum possible rigor (i.e. all conditions for a knowledge-claiming research are met). Such practice will help avoid any questions and doubts about value of the study. Also, one should note that one does not need to know exactly if and how the study results can be used (e.g. for what kind of decisions) in order to declare a study to be "knowledge-claiming".
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