Your Responsibilities as Site Staff, and What the Sponsor Does

Part of Human Subjects Protection for Clinical Research Staff: Who Protects Participants.

About 6 minutes. Free, in your language, no account needed.

Why this matters

Participants are protected by several parties at once: the IRB, the investigator, the sponsor and you. Each has a different job. When everyone assumes someone else is watching a particular risk, that risk goes unwatched. This lesson sets out who is responsible for what, so you know where your own duties begin.

ICH E6(R3) is the international baseline in this course. The US federal regulations (HHS 45 CFR 46, FDA 21 CFR 50 and 56, HIPAA 45 CFR 164) are taught as the detailed worked example, and passages that name them are US law. Outside the United States, follow your national law and ethics committee requirements. State or local rules may add requirements.

The investigator carries ultimate responsibility

ICH E6(R3) lets investigators delegate trial-related activities, and most do. A coordinator takes on consent conversations, a nurse takes on procedures, an assistant takes on data entry. But delegation does not move the responsibility. The investigator retains ultimate responsibility for the trial at the site and must maintain appropriate oversight of the people and activities delegated.

The guideline spells out what that involves:

For you, this has a direct meaning: do only what you have been delegated to do, and make sure the delegation record reflects your tasks. If you are asked to take on something that is not on the record, say so before you do it. A good habit is to ask to see the delegation log on your first day and to check that it includes the tasks you are actually performing.

What the investigator must do before and during the study

ICH E6(R3) lists several investigator duties that matter to site staff:

Notice the recruitment point. An advertisement, a flyer or a posting is not outside the approval process. If it is a way of reaching participants, it is part of what the IRB reviews. If you are asked to post or send something new, ask whether it has been approved.

What the sponsor does

Sponsors have their own duties, set out in section 3 of ICH E6(R3). You will not do the sponsor's work, but you will feel it. Among the section headings are:

In plain terms, the sponsor oversees the trial, manages quality, assesses and reports safety information, and confirms that review by the IRB/IEC has taken place. A good habit: when someone from the sponsor side asks to see consent records or approvals, treat the request as part of how participants are protected, not as a test of you.

Relying on an external IRB

Under ICH E6(R3), wherever the study runs, the investigator must have the IRB/IEC's documented approval before starting.

In the United States, an institution need not run its own IRB. OHRP's training says it may rely on an external IRB, such as another institution's IRB or an independent IRB. Under the Common Rule, when an IRB the institution does not operate oversees the research, the institution and the IRB's organization document the reliance and the responsibilities each takes on (46.103(e)). OHRP's training says the relying institution must comply with the external IRB's determinations. Each institution in a cooperative project stays responsible for safeguarding subjects and complying with the rule (46.114(a)), so local duties such as training, delegation and institutional policy stay with your site. OHRP's guidance treats a site as generally "engaged" when its staff, for the research, obtain data through intervention or interaction, obtain identifiable private information, or obtain consent. Your IRB office knows whether your site is engaged and which IRB is the IRB of record.

IRB records

IRB records are retained for at least three years, and they are accessible to the agency for inspection and copying. Under both HHS and FDA rules, the three years run after completion of the research (45 CFR 46.115(b); 21 CFR 56.115(b)). This is the IRB's duty, not yours. The point for you is that records of review exist, can be inspected, and should be consistent with what you have on file at the site.

In practice

A new research assistant joins a study at a community clinic. On day one she asks the coordinator, "What am I delegated to do?" They look at the delegation log together. She is listed for scheduling and data entry. The coordinator mentions that she will eventually help with consent, but not until the PI adds that task and confirms her training. The assistant does not take part in a consent conversation that week even when a participant arrives early and the room is short-staffed. She asks a delegated colleague to step in.

What this looks like when it goes wrong

A busy nurse is asked by a colleague to cover a consent visit. She has watched many consent conversations and feels she knows what to say. She conducts the visit, and the participant signs.

At the next monitoring visit, the monitor sees that the nurse's name does not appear on the delegation record for consent. The investigator had not delegated that task to her. The problem is not that the nurse was careless. It is that nobody had checked whether she was authorized and qualified for this specific task. Nobody can now show that the person who obtained consent was authorized to do so.

Key takeaways