Request to Assist

Often these requests ask you to do one of the following:

• Provide researchers with data for their research that your office may have as normal business records
• Provide researchers with a list of emails of TAMU-CC individuals that fit their study’s inclusion/exclusion criteria so they can send recruitment materials to those individuals
• Send their recruitment materials to individuals in the listserv your office manages or to an email list your office has of TAMU-CC individuals that fit their study’s inclusion/exclusion criteria
• Help them identify individuals from our campus who fit their study’s inclusion/exclusion criteria
• Help them recruit/consent individuals from our campus who fit their study’s inclusion/exclusion criteria

There are two main questions to answer in these scenarios:

1. Do they have IRB approval at their home institution that allows them to conduct the study?
2. Is local TAMU-CC IRB approval required?

Do NOT complete the researcher’s request until both of these questions have been answered. Otherwise, you could be in a non-compliance situation of having conducted research without IRB approval.

Question 1: Do they have IRB approval?

This question can be answered simply by having the individual request the action to provide a copy of their IRB approval letter. Any requestor not able to produce an IRB approval letter (or a letter from the IRB office stating IRB approval is not required) should have their request denied.

Question 2: Is local TAMU-CC IRB approval required?

This question is a bit trickier as the answer will depend on the situation and whether the activity level for TAMU-CC faculty, staff, and students rises to the level of engaging TAMU-CC in research.

If actions requested engage TAMU-CC in research, then local TAMU-CC IRB review would be required. If the requestor has not secured this, please forward them to IRB Initial Submission or irb@tamucc.edu. If actions requested do not engage TAMU-CC in research, then local TAMU-CC IRB review is not required.

Generally, if TAMU-CC employees or agents interact for research purposes with any human subject involved in the research project, then TAMU-CC is engaged and local IRB approval will need to be obtained. However, there are some limited exceptions to this general rule.

See Checklist, Engagement in Research Determinations for all the exceptions (link: https://tamucc-my.sharepoint.com/:w:/g/personal/rebecca_ballard_tamucc_edu/EVMxFVjBk_VAkI1amCDfuNcBFGNEBTfH5462-W7w5O3Kxg?e=EvwqxI)

The exceptions that most often apply in these situations is if the request is limited to asking you to do ONLY the following:

• Release to the investigators information pertaining to the human subjects. This can include identifiable private information.

Examples:

• Provide them with data for their research that your office may have as normal business records.
• Provide them with a set of emails of TAMU-CC individuals that fit their study’s inclusion/exclusion criteria so they can send recruitment materials to those individuals.

Note: The release of this information may need to comply with other regulations, such as FERPA, or internal business policies. Before releasing the data, be sure these processes are also followed to comply with regulations/rules outside the human subjects regulations.

• Inform prospective human subjects about the availability of the research.

Examples:

• Allow the researcher to post a recruitment flyer on a university bulletin board (physical or electronic).
• Send the investigator’s recruitment email for them through a listserv or list of contacts you have.

To ensure TAMU-CC is not engaged, TAMU-CC employees should NOT consent or be the contact person to answer questions about the research. This needs to remain with the research team.

Those posting or sending emails through this list serve may need to comply with other rules, such as obtaining permission to post on campus bulletin boards. Before sending the recruitment material on behalf of the research team, be sure these processes are also followed to comply with regulations/rules outside the human subjects regulations.

If the research team is asking you to actively identify individuals from our campus who fit their study’s inclusion/exclusion criteria or is asking you to consent these individuals. A question to ask yourself to help define this line would be, "do I need to know details in the research protocol to be able to perform the task asked of me?". If yes, you are likely getting into engaged territory and should contact the TAMU-CC IRB office.

If in doubt, forward the request to irb@tamucc.edu.