Dear all,
First off, please excuse this very lengthy post. But I promise it is with good reason, and I am confident this will resolve the issues that have been discussed by Tina and Jacob, and a few others have raised regarding the survey design protocol.
Initially, I do want to point out that Jacob has very good intentions by insisting that we go through the lengthy "Survey Design" protocol, which is loosely based off of University of Michigan’s protocol.
Similar to Tina, when Jacob raised this issue in the beginning, I was surprised that his past institution expected such a rigorous protocol for collecting non-attributable information via a survey. It defied my understandings and personal experiences regarding human subject research, and when one needs to get formal IRB approval/exemption. Anyhow, after much debate with Jacob, I decided to go ahead and complete the protocol for the sake of progress with the survey effort, and because I could have been missing something regarding federal regulations regarding such matters.
I will admit filling out the protocol was long, complicated and felt extremely conservative. In the environment I work in, I deal with highly sensitive information all the time with extremely conservative processes. Even under such a work environment, I can’t remember coming across a situation where I had to go through such a lengthy process to gather similar information our survey aims to collect. But as a sanity check, I sought advice from multiple researchers from several institutions and IRB board members to see if I was missing something regarding Jacob’s position on this. Their reaction was similar to mine, but we all admitted that it was best to learn the appropriate federal regulations to make a definitive determination of how the Committee should proceed in the future when it comes to such matters. In other words, what our gut instinct and institutional experiences suggest aren’t necessarily what we should lean on. Federal regulations are what we should be abiding by.
So I invested substantial amount of time to read through the applicable sections of the Code of Federal Regulations, Title 45 – Public Welfare (45 CFR) to get the ultimate answer on whether or not the Committee needs to follow the processes suggested by Jacob for this study or similar studies in the future. Please note that this is the same regulation the U.S. Department of Health & Human Services (which includes NIH) abides by.
According to 45 CFR, to establish our IRB status, we must first determine if our study is considered “human subject research”. For an investigation to be considered, “human subject research”, two separate determinations must be made in order to evaluate whether or not the study is IRB exempt:
- Can the activity be considered research? If the answer is “yes”, then the investigators must follow up with a second determination,
- Does the research involve human subjects?
Both determinations must be made using the
regulatory definitions of “research” and “human subjects” in 45 CFR 46.102 (a-j) in order for the investigation to be considered NOT IRB exempt. If both criteria are not met, then the investigation is considered IRB exempt in accordance to the CFR. According to 45 CFR 46.102(a-j), “research” and “human subjects” are defined as follows:
- Research-“a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes.” Investigators unsure of whether an activity constitutes human research should contact their IRB.
- Human subjects-“living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” Activities in which a researcher collects private, identifiable information about third parties would meet the definition of “human subjects.”
Depending on how strictly you interpret the definition of “research”, I can see how one might consider our survey activity meets this definition. But I would be inclined to say that our work does not satisfy this definition. But, as I said, it can be debated. So let's look at the second criterion.
When we look at the definition of “human subjects”, either condition (1) or (2) must be met in order to satisfy the definition of “human subjects” per 45 CFR 46.102. In other words, both must determine "false" in order for our work to not be classified as human subject research.
Under human subject definition condition (1), intervention and interaction with individuals are defined as:
- Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. – Our situation does not satisfy this.
- Interaction - includes communication or interpersonal contact between investigator and subject. – Our situation does not satisfy this because we are not collecting the data though direct communication or interpersonal contact with the participants.
So condition (1) of “human subjects” definition does not apply to the Committee’s survey activity.
When we consider condition (2), we need to determine if the following four questions we are asking about the survey participant are considered “identifiable private information” per the definitions listed in the CFR:
- What is the primary setting you work in?
- What is your primary field of academic/professional training?
- What is your highest level of education?
- How familiar are you with Computational Modeling and Simulation (M&S)?
According to 45 CFR 164.514(b)(2)(i), the following are considered “identifiable private information”:
(A) Names;
(B) All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census:
- (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and
(2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
(C) All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
(D) Telephone numbers;
(E) Fax numbers;
(F) Electronic mail addresses;
(G) Social security numbers;
(H) Medical record numbers;
(I) Health plan beneficiary numbers;
(J) Account numbers;
(K) Certificate/license numbers;
(L) Vehicle identifiers and serial numbers, including license plate numbers;
(M) Device identifiers and serial numbers;
(N) Web Universal Resource Locators (URLs);
(O) Internet Protocol (IP) address numbers;
(P) Biometric identifiers, including finger and voice prints;
(Q) Full face photographic images and any comparable images; and
(R) Any other unique identifying number, characteristic, or code;
Since the four questions we are asking of the survey participants do not fall under any of these pieces of information, we are not collecting any identifiable information.
Consequently, the definition of “human subject” is not met. This means, we pass the test for IRB exemption. Based on this, I consider the "Survey Design" protocol suggested by Jacob to be informative. But the Committee is not required to follow it since the above information from the CFR clearly shows that we are IRB exempt and we are not dealing with any attributable data. However, we can continue to use the information we have already gathered via the "Survey Design" protocol. Besides, I think we would have collected most of it any way in one form or another. But there should be no expectations of the Committee to follow it.
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Forward Plan Recommendation: The Committee should not be subjected to processes directly taken or partially derived from other institutions. Instead, we should follow the official federal regulatory processes as listed above from this day forward.
Academic and research institutions can impose whatever processes they see fit on their investigators. Imposing other institutional processes on the Committee is not appropriate since those institutions are not the governing body of the Committee. The Committee is under IMAG, which is directed by the NIH. Therefore, it is most appropriate that we always defer to the Code of Federal Regulations listed above, and not any other institution’s protocol.
Future data collection initiatives will proceed in accordance to 45 CFR. This will ensure that we are following ethical practices, ensure the credibility of our work and minimize subjectively imposed processes.
Unless there is a majority disagreement with my assessment and/or recommendation, I think this should be our official process. But, in general, I am strongly against imposing a protocol similar to the the current one implemented for the survey design. It is overly conservative for our purposes.
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I encourage you all to review the CFR when you get a chance. I personally found it very informative, and I feel better equipped to deal with future IRB protocols in a more streamlined manner in my personal work as well as extramural activities.
Thanks again to Jacob for raising this important issue. Without the concerns that he raised, we could have been at risk of making some bad assumptions regarding where we stood with IRB processes. Now we have the correct federal regulation code we need to follow to ensure that we are conducting our work ethically, and ensure strong credibility in our work.
Thanks for your patience, everyone.
Lealem