01 · The Question
Should you ask first, or design the study first?
Suppose your research idea depends on recruiting teachers from a particular school system, obtaining administrative records from a university, using specialized laboratory equipment, or collaborating with someone who has expertise you do not possess. You could develop the complete design first and approach those people afterward.
That sequence feels orderly, but it can be inefficient. You may spend weeks refining sampling, measurement, analysis, and timelines around a resource that turns out to be unavailable. The school cannot accommodate recruitment. The database does not contain the variable you need. The collaborator has no capacity this year. The laboratory equipment exists, but another project has booked it for the relevant period.
The alternative is not to seek formal approval for an unfinished study. It is to obtain enough preliminary information to determine whether important external assumptions are plausible before building the design around them.
03 · What You Need to Know
Early confirmation protects the design from false assumptions
Research planning often depends on information that the researcher does not control. NIH guidance on planning research explicitly recommends evaluating available resources and identifying collaborators while developing the research idea rather than waiting until every detail has already been fixed. It also suggests keeping the project concept somewhat flexible while resources and the team are being worked out.
That sequence makes methodological sense. The characteristics of available sites, populations, data, expertise, and infrastructure can legitimately shape the design.
Informal confirmation is a feasibility check, not formal authorization
The distinction is important because “we talked to the site” can mean several very different things.
Preliminary confirmation
Someone with relevant knowledge indicates that the proposed access, resource, collaboration, or activity appears plausible enough to continue planning.
Formal authorization
The responsible person or institution grants the approval, agreement, access, or permission required before the relevant research activity can occur.
A department head saying that recruitment “should probably be possible” can be useful during early planning. It does not necessarily authorize you to recruit anyone. A data manager confirming that a variable exists can justify designing around that variable. It does not necessarily give you permission to receive the dataset.
Keep those distinctions visible in the research plan.
Confirm sites early when the setting constrains the design
A site may determine much more than where the study takes place. It can affect the accessible population, recruitment rate, staffing, available rooms, equipment, scheduling, local workflow, implementation procedures, and institutional requirements.
NCCIH guidance for clinical study accrual recommends evaluating recruitment feasibility during protocol development, including the availability of the study population, participant burden, site resources, competing studies, and the site's interest in the research. Although these recommendations concern clinical research, the underlying planning principle is relevant more broadly: a site should not be treated as an interchangeable container when its real characteristics determine whether the study can operate.
For a school-based study, for example, you might preliminarily ask whether the relevant student population is present, whether the proposed research period conflicts with examinations, and whether classrooms can accommodate the procedure. Those answers may influence the design long before formal recruitment begins.
Confirm the data, not merely the existence of a database
“The university has student records” is not enough to establish feasibility for a study requiring specific student-level variables over several years.
Before designing around existing data, establish whether the required variables are actually recorded, how they are defined, what years or cases are covered, whether relevant identifiers or linkage fields exist, how complete the records are likely to be, and what restrictions govern access.
You may not be permitted to inspect individual-level data at this stage. Often, metadata, a data dictionary, documentation, aggregate counts, or confirmation from the custodian can answer the preliminary feasibility question without giving the researcher unauthorized access to protected information.
Confirm that the collaborator is interested in the actual role you need
A colleague may enthusiastically support the research idea while having a very different understanding of their role.
If the project depends on their contribution, discuss what you actually need. Are you asking for methodological advice at two meetings? Access to a laboratory? Recruitment assistance? Analysis of specialized data? Co-development of an intervention? Supervision of research assistants?
NIH planning guidance emphasizes identifying gaps in expertise and assembling collaborators capable of strengthening and executing the research plan. That implies more than attaching names to a proposal. The required expertise and resources should correspond to real contributions.
Confirm the accessible population rather than assuming it from organizational size
A university may employ 2,000 faculty members, but that does not mean 2,000 people satisfy your eligibility criteria or can be approached. A hospital may treat thousands of patients annually while only a small number meet the study's clinical criteria during the recruitment window.
Where possible, obtain realistic counts or informed estimates of the potentially eligible population. Recruitment feasibility depends on the accessible pool, eligibility, approach rate, willingness to participate, retention, and study burden, not merely the headline size of the institution.
Research on feasibility planning similarly emphasizes assessing population availability, institutional capacity, equipment, personnel, time, and organizational willingness before full implementation.
Ask about constraints, not just permission
“Would your institution be interested?” is useful but incomplete. A positive answer can conceal conditions that fundamentally change the study.
The site may permit recruitment only through an institutional mailing list. Data may be released only in de-identified aggregate form. Interviews may be limited to particular hours. The collaborator may be available only after your planned deadline. Equipment may be accessible but require trained personnel whose time must be budgeted.
A better preliminary conversation explores the conditions under which participation would be possible.
Do not accidentally begin research during a feasibility conversation
Preliminary discussion must remain preliminary. Researchers should not begin recruiting participants, collecting research data, accessing protected records, or conducting procedures requiring approval merely because they are checking feasibility.
Formal requirements depend on the institution, jurisdiction, study type, and activity. For human-participant research, ethics review may require the protocol, instruments, informed-consent materials, and associated documents before research begins. WHO's own ethics review process, for example, requires such materials for projects under its remit.
When uncertain about what preliminary contact is permissible, ask the responsible institutional or ethics office.
Informal confirmation should become stronger as commitment increases
A useful way to think about confirmation is as an escalation rather than a binary event.
| Project stage |
Typical question |
Possible level of confirmation |
| Early idea |
Is this resource or setting plausibly available? |
Exploratory conversation or preliminary information |
| Design development |
What constraints must the design accommodate? |
Specific feasibility confirmation, documentation, metadata, or resource estimates |
| Formal proposal or protocol |
Can the named people and organizations support the proposed work? |
Documented commitments or letters where required |
| Before implementation |
Are we actually authorized to perform the activity? |
Required ethics, institutional, contractual, data-access, site, or other formal approval |
Not every possibility needs confirmation before design
Early feasibility checking can itself become excessive. If the design does not depend on a particular site or collaborator, contacting ten possible institutions before clarifying the research question may accomplish little. Similarly, asking a data custodian detailed questions before you know what variables the study requires simply transfers your uncertainty to someone else's inbox.
Start with dependencies that could substantially alter or terminate the proposed design. This follows the broader principle of verifying consequential assumptions with the people who actually control them.
Early confirmation can reveal that the design should change
That is not a failure of planning. It is one of the main reasons to ask early.
Perhaps individual-level data are unavailable, but aggregate records support a different question. Perhaps one site cannot recruit enough participants, but several sites could. Perhaps the preferred collaborator is unavailable, but another method avoids dependence on specialized expertise.
A study concept can remain somewhat flexible while resources and collaborators are assessed. That flexibility may produce a more realistic design than perfecting an idealized plan and then asking reality to accommodate it.
Watch Out
Do not write “access confirmed” when someone has merely expressed interest. Record accurately whether a dependency is assumed, preliminarily discussed, provisionally supported, formally agreed, or fully authorized.
04 · A Practical Example
A ten-minute feasibility question changes the entire design
Hypothetical Example
Designing a study around institutional learning analytics
A researcher plans to investigate whether patterns of learning-management-system activity predict course completion. The proposed design requires student-level event logs, demographic variables, final grades, and identifiers allowing records to be linked across systems.
Initial assumption The researcher knows that the university maintains learning analytics and student records and therefore assumes the required dataset can be constructed.
Preliminary confirmation
Before finalizing the design, the researcher asks the relevant data custodian which fields are retained, how far historical records extend, whether systems can be linked, and what level of data could potentially be released following the required approvals.
Constraint discovered
Detailed event logs are retained for only part of the intended period, and direct identifiers cannot be released to the researcher. However, an approved intermediary could potentially perform the linkage and provide a de-identified research file.
Design consequence
The researcher shortens the historical period, revises the linkage workflow, adjusts the proposed variables, and incorporates the intermediary into the data-management plan.
Formal process comes later
The preliminary conversation does not authorize data access. The researcher still completes the applicable ethics, institutional, and data-governance processes before receiving research data.
The preliminary conversation did not replace formal design. It made formal design worth doing because the study was now being built around conditions that might actually exist.
07 · A Quick Checklist
Before designing around an external dependency
Check the assumption at the level your current planning stage requires:
Have I identified the sites, data, people, facilities, or resources on which the design materially depends?
Am I speaking with someone who actually knows or controls the relevant resource?
Have I confirmed the specific characteristics the design depends on rather than merely asking whether participation is possible?
For existing data, have I checked relevant variables, coverage, granularity, linkage, documentation, and access conditions?
For sites, have I checked the accessible population, timing, capacity, local constraints, and likely recruitment pathway?
For collaborators, have I discussed the actual role, expertise, workload, timing, and resources required?
Have I clearly distinguished preliminary support from formal permission?
Do I know which approvals or agreements must still be obtained before the research activity begins?
