Stakeholder | Open access (online protocol) | Restricted access (NDA)* | ||
---|---|---|---|---|
Advantages | Disadvantages | Advantages | Disadvantages | |
Lead investigators | · Authorship acknowledged. | · Investigators do not have control over who has access to the protocol. | · Ownership established by the lead centre. | · Cost and time involved in establishing and defending NDAs. |
· Plagiarism can be identified. | ||||
· Potential for plagiarism reduced. | ||||
· Investigators must adhere to protocol, or explain reasons why not. | · Protocol could be adapted or plagiarized by other investigators. | |||
· Need to report all amendments to protocol. | ||||
· High degree of rigour associated with adhering to protocol and reporting. | ||||
· The lead investigator is the only one given credit for the protocol; other investigators do not receive adequate recognition of the effort that they have expended in developing the protocol. | ||||
· Co-investigators in other centres will need to sign NDAs before being able to establish the trial in their centre. | ||||
· Investigators might be less accountable for changes to protocol | ||||
Investigators’ institutions (universities, health care organisations) | · Affiliation acknowledged. | · Institution does not have control over who has access to the protocol. | · Ownership by institution established. | · Cost involved in establishing and defending NDAs. |
Peer-reviewed funding bodies | · Public knowledge of funded study (that is, use of funding). | · Protocol could be adapted or plagiarized by other investigators. | · Confidence that protocol will not be plagiarized. | · Public cannot access study protocol. |
· Less certainty that study will be conducted as funded. | ||||
· Greater accountability of investigators to adhere to funded protocol. | ||||
· Greater certainty that study will be conducted as funded. | ||||
Industry funding bodies | · Public knowledge of funded study (that is, use of funding). | · Widespread access to protocol. | · Confidence that protocol will not be plagiarized. | · Less certainty that study will be conducted as funded. |
· Protocol could be adapted or plagiarized by other investigators. | · Others (competitors/public) will not have easy access to funded study protocol. | |||
· Greater accountability of investigators to adhere to funded protocol. | ||||
· Greater certainty that study will be conducted as funded. | ||||
Site collaborators | · Availability of full protocol if they wish to seek that information. | · May believe that the protocol is open to change. | · Availability of full protocol if they wish to seek that information, but only if willing to sign a NDA that has been first agreed upon by their institution and the lead investigator’s institution. | · Cannot share details of the protocol with colleagues unless they are involved in the study. |
· Can share the protocol with other potential collaborators within their institution. | ||||
· Cost (time/effort) involved in review and approval of NDA, even when the site subsequently decides not to participate. | ||||
· More open discussion. | ||||
Collaborators’ institutions (universities, health care organisations) | · Availability of full protocol if they wish to seek that information. | · May believe that the protocol is open to change. | · Availability of full protocol for review before joining the study if NDA is signed. | · Cost involved in legal review and approval of NDA. |
· Co-investigators’ institutions need to sign NDAs before being able to establish the trial in their centre. | ||||
End-users of evidence (clinicians, policy makers) | · High degree of rigour associated with adhering to protocol and reporting. | · Potential for delay in publication because of greater rigour required. | · The study is unlikely to be duplicated. | · Possibility of selective and biased reporting. |
· Possibility of adopting flawed evidence. | ||||
· Can check that findings are appropriately reported. | ||||
Patients (potential trial participants) | · Availability of full protocol if they wish to seek that information. | · Misinterpretation of open access information by those without sufficient background knowledge to understand it. | · Potential trial participants can be more confident the protocol is unique. | · Patients would need to ask specifically for a copy of the protocol if they wished to obtain details of the study. |
· Can check that results are presented as intended. | ||||
· Possibility of selective and biased reporting. | ||||
· Possibility of flawed evidence being adopted. | ||||
Society generally | · Potential for replication of research, leading to availability of studies for inclusion in meta-analyses and more rigorous evidence to support practice. | · Potential for research being duplicated unnecessarily (waste of scarce resources). | · Trial is unlikely to be replicated. | · Possibility of flawed evidence being adopted. |
· Protocols of publicly funded research will be openly available to the public. |