Development and Pilot of a REDCap Electronic Informed Consent Form for Research: An Example from the ROPE Study

Abstract

A study that describes the development of an electronic informed consent, using the REDCap platform, and the results of a pilot study to assess participants’ understanding and acceptance of that electronic informed consent for use in a research study.

Conducting an informed consent for research is described as the “process of information exchange” (U.S. Food & Drug Administration [FDA], 1998, para. 39) that includes any and all of the information given to potential participants, written or verbal. For the informed consent process to be valid, an adequate amount of information regarding the study must be disclosed. The Code of Federal Regulations (45 CFR 46) requires specific elements to be included in the consent process (Protection of Human Subjects, 2020). At a minimum, these elements include:

1. A statement of the purpose of the research.

2. Any foreseeable risks.

3. Any expected benefits.

4. Alternative procedures.

5. Confidentiality of records.

6. Compensation and medical treatments that are available should a research-related injury occur.

7. Whom to contact for questions.

8. A statement that participation is voluntary.

9. Information about identifiable private information usage. (Protection of Human Subjects, 2020)

Ethical writings regarding the informed consent process – such as the Nuremberg Code and Belmont Report – include in their fundamental principles, both voluntariness and respect for persons. To satisfy these principles, potential participants must be able to understand and comprehend the information given to them for their consent to be truly voluntary.

Background

Challenges to Traditional Paper and Face-to-Face Informed Consent Process

The Informed Consent Form document (ICF) has historically been a paper document that is used as a basis for face-to-face exchange of the required information. The signed paper ICF affirms the participant, or their authorized representative, feels sufficient information has been delivered, comprehends the information delivered, and understands that participation in the research study is voluntary (Pandiya, 2010).

Multiple studies have expressed concerns with the traditional paper consents (Lorell et al., 2015; Nishimura et al., 2013; Flory & Emanuel, 2004). Paper informed consents are often too long and too difficult for potential study participants to read and comprehend (Henderson, 2011; Lorell et al., 2015). Trying to describe a research study with enough information to meet the Institutional Review Board’s requirements can often require a lengthy consent document (Lorell et al., 2015). In turn, the length of such documents has been cited by many researchers as a deterrent for potential study participants (Lorell et al., 2015).

The traditional process of exchange of information with a paper ICF also requires the principal investigator, or a member of their research team, be available at the time and place where the potential participant is located such as the hospital or clinic. This can be a challenge if there are not enough research team members to be in multiple places at one time or if potential participants arrive around the clock with a short time frame for enrollment such as in a labor and delivery unit. Limited study funding may preclude adequate numbers of research team members from being in the right place at the right time for face-to-face consenting, ultimately negatively impacting enrollment (Ahmed, 2011).

Another challenge with paper ICFs is the storage of the documents. Paper ICFs need to be stored in a secure physical location and may also need to be electronically scanned and stored. Either method – paper or scanned storage – is fraught with issues for document retrieval (Madathil et al., 2013). Moreover, paper consents either require an in-person interaction with study participants or mailing of documents between the researcher and the potential participant. In light of the recent pandemic, it has become desirable to reduce in-person interactions to reduce exposures for both the study team and the potential participants. If paper consent documents are mailed as a replacement for in-person consenting, this can result in an extra burden in costs for postage, the time between approach and consent, and the time between consent and the beginning of the study procedures.

An electronic informed consent form (e-ICF), for the purpose of this study, is an informed consent document presented in an electronic format. There are a wide range of e-ICFs, from the paper informed consent document presented on a secure, electronic platform, to interactive multi-media consents. The e-ICFs must follow the same regulatory requirements as a paper consent. the Office for Human Research Protections (2016) and FDA (2003) publications provide guidance on the use of e-ICFs to aid or to substitute for paper consents and the use of electronic signature for documenting the informed consent.

Researchers have investigated e-ICFs as an alternative method for the informed consent process that may address the challenges associated with the face-to-face consenting and/or paper documents. Most importantly, comprehension of the ICF by potential research participants was maintained, if not improved, with e-ICFs (Rowbotham et al., 2013; Rothwell et al., 2014). However, there are limitations to the use of an e-ICF, including the time and cost to produce and implement this approach (Simon et al., 2016). Limited funding may make the use of an e-ICF not feasible for the average researcher. Security, privacy, and confidentiality can be costly. For example, FDA-regulated clinical investigations require electronic systems that must be secure with restricted access which may be cost-prohibitive to some researchers.

The Rule Out Pre-Eclampsia (ROPE) study – a pre-existing study at the University of Iowa that enrolled women who were going into labor – provided an opportunity to develop an e-ICF. As the ROPE study progressed, we found that we were missing the opportunity to approach a large number of potential participants who were going into labor outside of the available hours of our research team who enrolled participants in the ROPE study. This limitation provided the impetus for this research team to develop an e-ICF to be used for the ROPE informed consent document.

Methods

Development of the ROPE e-ICF Using REDCap

The ROPE e-ICF was developed by a collaboration between the ROPE research team and the University of Iowa’s Institute for Clinical and Translational Science (ICTS) informatics team. REDCap was used to design, execute, and host this e-ICF (Harris et al., 2009; Harris et al., 2019). The Biomedical Informatics Core in the ICTS manages REDCap. REDCap’s system securities include secure logins, firewalls, data encryption at rest, remote system logging and configuration, change management, and a two-factor authentication. Data are stored on an in-house server and backed up and replicated every 15 minutes at a secured offsite center. Disaster recovery is available if needed (Harris et al., 2009; Harris et al., 2019).

A mock-up of the e-ICF based on the original paper consent for the ROPE study was developed. The e-ICF could be displayed on any electronic device but, for this study, an iPad was used. The e-ICF was divided into eight sections based on the requirements of the federal regulations. These sections included:

1. Overview.

2. Purpose of the ROPE study.

3. Procedures.

4. Benefits and Risks.

5. Costs and Payments.

6. Confidentiality.

7. Use of Health Information.

8. Voluntary Aspect.

Each section appeared on its own page. We were struck by the amount of information displayed on an electronic screen. The length of text on the page would require potential participants to scroll down the page causing concern they would treat the text similar to the ‘privacy policies’ and ‘terms of services’ of internet sites which, according to a study by Deloitte, is only read by three percent of the population ages 18-34 (Deloitte, 2017). An idea for resolving this concern came from a study that examined the use of a simplified consent form for biobanking (Beskow et al., 2010). Beskow and colleagues (2010) used a shorter version of a consent form on an electronic device with ‘More Information’ buttons that contained additional detailed information. Therefore, the ROPE e-ICF was modified to use a summary of information for each section. After reading each section, the participant had three options:

• The first option was to ‘agree’ to that section of the consent, indicating the participant was satisfied with the amount of information.

• The second option was to ‘learn more’ about that portion of the consent. If ‘learn more’ was selected, the next screen presented a detailed explanation of the corresponding section of the consent.

• The last option was to ‘stop,’ indicating the potential participant did not want to participate in the research study.

One of the three options had to be selected to move to the next section of the consent.

Unique to the e-ICF, compared to the traditional paper ICF, was our addition of review questions related to the eight sections of the consent used to assess and reinforce understanding of each corresponding section prior to the potential participant’s signature. We chose questions that reviewed information required by federal regulations. These questions are referred to as the ‘e-ICF Comprehension Survey’ henceforth. The e-ICF Comprehension Survey questions were ‘true/false’ questions phrased as a statement; for example, ‘You and your child will personally benefit from participating in this study.’ If the correct answer was chosen, the next section would appear. If the incorrect answer was selected, the correct information was presented and reinforced. Participants were not excluded for incorrect answers. The participant’s electronic signature was collected via the touch screen of the iPad after all sections of the consent were reviewed and agreed upon by the study participant and the e-ICF Comprehension Survey was completed. Once signed and submitted, the consents were electronically filed and could not be altered from their original submission.

Piloting the e-ICF

Subjects and Setting

This descriptive pilot study of the ROPE e-ICF was conducted at a large midwestern healthcare center following Institutional Review Board approval. We set out to enroll a convenience sample of 30 simulated patients consisting of English-speaking, pregnant or postpartum women, identified from the Maternal Fetal Tissue Bank research registry for pregnant women at the University of Iowa. To assess comprehension and acceptability of the e-ICF, we elected to use simulated participants. For this pilot study, simulated patients are women who would be similar to those eligible to participate in the ROPE study (i.e. met the inclusion/exclusion criteria). However, these simulated participants only completed the e-ICF for the purpose of this pilot study, were not enrolled in the ROPE study, and did not undergo ROPE study procedures. Using simulated participants would allow us to conduct iterative revisions to the e-ICF; therefore, an interim analysis was planned to be completed after approximately fifteen simulated patients had participated in order to identify any problematic areas of the consent form. Participants enrolled before the interim analysis were labeled as being part of Phase 1, and those after the interim analysis were part of Phase 2.

Instruments

The participants’ understanding of the e-ICF was measured with two instruments: 1) the e-ICF Comprehension Survey, previously described; and 2) an adaptation of the Quality of Informed Consent (QuIC) questionnaire developed by Joffe and colleagues (2001), administered immediately following completion of the e-ICF via REDCap. The QuIC was originally used to measure participant’s understanding of important concepts of oncology clinical trials displayed via an ICF (Joffe et al., 2001), and has been used by other researchers for examination of the ICF (Ormond et al., 2009; Rothwell et al., 2014). The QuIC questionnaire consists of two separate parts:

1. Actual knowledge about the study (objective).

2. Perceived understanding (subjective) of the study.

Each part has an individual scoring system. Parts of the questionnaire that were applicable to this study were modified producing the ‘Adapted QuIC questionnaire’ (A-QuIC).

A-QuIC Part A measures objective understanding by providing statements and asking participants whether they agree or disagree with the statement, or if they are unsure. The purpose of Part A is to measure how well the participant understands the study for which they are consenting. For each statement there was a correct response, but participants were given the option to say they were unsure rather than guess the correct answer. As developed by Joffe and colleagues (2001), to reduce agreement bias, some questions have ‘agree’ as the correct answer while other questions have ‘disagree’ as the correct answer.

A-QuIC Part B assesses subjective understanding, or how well participants feel they understand the study in which they are consenting to participate. A component of the consent is presented, and the participant is asked to rate how well they felt they understood that component. Subjective understanding measures the participant’s self-perception of being well-informed about the key aspects of the research study. For this section, we opted to use a visual analog scale for clarity purposes, as the iPad screen was not able to accommodate the five choices for a Likert scale in an uninterrupted line. Participants were instructed to use the sliding bar on the visual analog scale to approximate their understanding of each statement. Rating a statement to the far left (analyzed as a score of 0) indicated ‘I didn’t understand this at all,’ while moving the sliding bar to the far right (analyzed as a score of 100) indicated ‘I understood this very well.’ If the participant some-what understood the statement, to approximate their understanding they would move the bar somewhere in the middle.

Additionally, after completion of the study, a debriefing was conducted to assess if the participant had any difficulty in completing the e-ICF. Each participant was asked if they had any difficulties completing the e-ICF on the iPad and if they had any feedback to provide regarding the e-ICF. Any difficulties reported by the participants were recorded verbatim by the research team member.

Enrollment and Consent Completion Procedures

Research staff approached a convenience sample of eligible pregnant and postpartum women at their routine obstetrical appointments. Potential participants were given an information sheet describing the purpose of the study, the trialing of the electronic consent, and their role as a simulated patient. The participants completed the e-ICF and A-QuIC questionnaires on an iPad in their examination rooms while waiting to be seen by their provider. Participants could pause and resume the e-ICF if a care provider entered the room. Research members were not in the room when participants completed the e-ICF but were outside the patient’s room to address any questions or potential issues. Upon completion of the e-ICF (including the e-ICF Comprehension Survey), the participant was then presented the A-QuIC Part A and the A-QuIC Part B questionnaires via the iPad. Before the participant left the clinic following their visit, the research team member retrieved the iPad and debriefed the participant.

Analysis

The study was done in two phases. After Phase 1, the results of participants that had completed e-ICFs were reviewed to identify areas of concern. Based on these results, the e-ICF was to be revised and retested in Phase 2. Descriptive statistics, frequencies, means, and standard deviations were used to analyze the participants’ responses to the e-ICF Comprehension Survey and the A-QuIC Part A and the A-QuIC Part B questionnaires.

Results

Twenty-eight of 29 women that were approached to be simulated patients for the e-ICF study agreed to participate. Of the 28 women that began the study to pilot the e-ICF, the majority identified as Caucasian and non-Hispanic with an average age of 32 years (range 21-41). The average gestational age of the women was 30 weeks and 6 days, with a range of 15 weeks and 3 days to 40 weeks and 1 day. One participant was postpartum by 7 weeks and 6 days. See Table 1 for complete demographic information.

Table 1.

Demographics (n = 28)

Age	Mean 32	Range 21-41
Race	Number	Percentage
Caucasian	26	92.9
African American	1	3.5
Declined	1	3.5
Ethnicity	Number	Percentage
Hispanic	2	7.1
Non-Hispanic	25	89.3
Declined	1	3.6

Twenty-five of the 28 women that began the study signed the e-ICF and completed the e-ICF and A-QuIC Part A and Part B questionnaires. For the three participants that did not complete all components, we included the components that each participant completed in our analyses. These participants cited time constraints such as needing to return to work as their reason for not completing study procedures.

Phase 1 Results

After 18 participants, we reviewed the results of the e-ICF Comprehension Survey and the QuIC Parts A and B questions. Table 2 reports the results of the e-ICF Comprehension Survey. The percentage of correct answers for each question ranged from 94-100% correct. Analysis of the individual scores of participants across the e-ICF Comprehension Survey was also completed. Of the 18 participants, 13 had answered all comprehension questions correctly. Of the remaining five, no participant answered more than one question incorrectly.

Table 2.

e-ICF Comprehension Survey

	PHASE 1 (n = 18)		PHASE 2 (n = 10)
Section of consent and wording of question	n completed	% correct	n answered	% correct
1) Overview & Purpose The main reason for doing this study is to help us develop a new test for preeclampsia.	18	94%	10	100%
2) Procedures The only thing we may take from you is urine.	18	94%	9	100%
Procedures Your sample will be given a code rather than using your name to help protect your privacy.	18	94%	9	100%
3) Benefits & Risks You and your child will personally benefit from participating in this study.	18	100%	9	100%
4) Costs & Payment You will not have any costs for participating in this study.	18	100%	9	100%
5) Confidentiality We will keep your and your child’s participation in this research study confidential to the extent permitted by law.	18	100%	9	100%
6) Use of Health Information You can participate in this study WITHOUT permitting us to use your protected health information.	18	94%	9	89%
7) Voluntary Aspect My doctor will decide whether or not I join this study.	18	94%	10	90%

The scores for A-QuIC Part A (objective understanding) are presented in Table 3 for each statement. In A-QuIC Part A, the question regarding whether governmental agencies could inspect medical records of participants (six incorrect responses out of 17) and the question related to compensation for a research-related injury (five incorrect responses out of 17) were the questions most frequently answered incorrectly. The question on the purpose of the proposed ROPE study, that is ‘the test that is being done as part of this research study has already been proven to be a good test for preeclampsia,’ demonstrated the highest number of ‘unsure’ responses(11 unsure responses out of 17) and a high number of incorrect responses (five incorrect responses out of 17).

Table 3.

A-QuIC Part A Objective Actual Knowledge

		PHASE 1 (n = 18)		PHASE 2 (n = 10)
Statement	n	Responses	n	Responses
When I signed the consent form, I knew that I was agreeing to participate in a research study.	17	*Agree = 16 Disagree = 0 Unsure = 1	9	*Agree = 9 Disagree = 0 Unsure = 0
The main reason this study is being done is to develop a test that will more efficiently diagnose pre-eclampsia for FUTURE patients.	17	*Agree = 17 Disagree = 0 Unsure = 0	9	*Agree = 9 Disagree = 0 Unsure = 0
I have been informed how long my participation in this research study is likely to last.	17	*Agree = 13 Disagree = 2 Unsure = 2	8	*Agree = 8 Disagree = 0 Unsure = 0
The test that is being done as part of this research study has already been proven to be a good test for pre-eclampsia.	17	Agree = 5 * Disagree = 1 Unsure = 11	8	Agree = 1 * Disagree = 5 Unsure = 3
As part of this research study, I will have additional risks because more ‘pokes’ will be done to have blood drawn.	17	Agree = 2* Disagree =13 Unsure = 2	6	Agree = 2* Disagree = 4 Unsure = 0
There may NOT be direct medical benefit to me from this research study.	17	*Agree = 16 Disagree = 0 Unsure = 1	9	*Agree = 9 Disagree = 0 Unsure = 0
By participating in this research study, I am helping the researchers learn more information that may help future pregnant women.	17	*Agree = 17 Disagree = 0 Unsure = 0	9	*Agree = 9 Disagree = 0 Unsure = 0
Because I am participating in a research study, it is possible that various government agencies, or others who are not directly involved in my care could review my medical records.	17	*Agree = 9 Disagree = 6 Unsure = 2	9	Agree = 6 Disagree = 1 Unsure = 2
The consent form I signed describes who will pay for treatment if I am injured or become ill as a result of participation in this research study.	16	*Agree = 8 Disagree = 5 Unsure = 3	9	*Agree = 8 Disagree = 0 Unsure = 1
The consent form I signed lists the name of the person who I should contact if I have any questions or concerns about this research study.	17	*Agree = 16 Disagree = 0 Unsure = 1	9	*Agree = 8 Disagree = 0 Unsure = 1
If I had not wanted to participate in this research study, I could have declined to sign the consent form.	17	*Agree = 17 Disagree = 0 Unsure = 0	9	*Agree = 9 Disagree = 0 Unsure = 0
I will have to remain in this research study even if I decide someday that I want to withdraw.	17	*Agree = 15 Disagree = 2 Unsure = 0	9	*Agree = 7 Disagree = 2 Unsure = 0

Note:

^*Indicates correct response

The results for A-QuIC Part B (subjective understanding) are presented in Table 4 for each statement. All statements were scored from 0 (poorly understood) to 100 (well understood). The average score for each statement was at least 82, indicating affirmative levels of perceived understanding of each statement. The statement with the lowest average (82) was the statement regarding payment for a research-related injury. This statement also had the two lowest scores from individual participants (nine and 17), indicating the section regarding payment for a research-related injury was ‘poorly understood’ by multiple participants.

Table 4.

A-QuIC Part B Perceived (Subjective) Understanding

	PHASE 1 (n = 18)				PHASE 2 (n = 10)
[AU: IS THERE A HEADER FOR THIS COLUMN?]	n	Mean	Range	SD	n	Mean	Range	SD
The fact that you are enrolling in a research study.	11	84	70 - 100	10.95	7	88	72 - 100	10.12
What the researchers are trying to find out in the research study.	13	88	69 - 98	9.78	7	92	87 - 100	4.54
How long you will be in the research study.	15	85	28 - 99	17.06	7	90	67 - 100	12.05
The procedures you will undergo.	16	91	78 - 100	6.42	8	87	60 - 100	11.88
The possible risks and discomforts of participating in this research study.	15	91	79 - 100	6.16	8	87	67 - 100	10.54
The possible benefits to YOU of being in this research study.	15	91	84 - 100	6.16	8	89	77 - 100	8.31
How your participation in this research study may benefit FUTURE PATIENTS.	17	92	78 - 100	5.79	8	92	75 - 100	8.43
The effect of the research study on the confidentiality of your medical records.	17	91	68 - 100	8.45	8	89	88 - 100	7.08
Who will pay for your treatment if you are injured or become ill because of participation in this research study.	16	82	9 - 100	28.2	8	86	68 - 100	12.44
Whom you should contact if you have questions or concerns about the research study.	16	91	62 - 97	8.38	8	92	75 - 100	8.44
The fact that participation in this research study is voluntary.	16	94	88 - 100	4.32	8	92	68 - 100	10.71
Overall, how well did you understand your research study when you signed the consent form?	16	90	71 - 98	756	8	88	70 - 100	9.54

Areas of the e-ICF were identified as problematic based on the review and discussion of the Phase 1 results by the research team. Changes to the e-ICF were instituted to improve the clarity of the e-ICF in areas regarding the purpose of the study and payment for injury. For example, a sentence was added to clarify the purpose of the ROPE study was to identify a novel blood test for preeclampsia: ‘Currently there is not a way to predict which women may develop preeclampsia during pregnancy.’ Additionally, clarification was added to the wording regarding research-related injuries and who would pay if an injury did occur: ‘This is a minimal risk study so the chance of physical injury is rare. If you are injured, treatment is available. You and/or your medical or hospital insurance carrier will be responsible for the cost of treatment.’ Wording regarding access to medical records was not changed as this wording is considered standardized language by our Institutional Review Board and cannot be changed.

Phase 2 and Final Analysis

Ten additional participants were recruited to analyze the revised e-ICF. The final analysis demonstrated continued high scores on the e-ICF Comprehension Survey (see Table 2). The percentage of correct answers for each question remained at almost 90% or above. Additional wording to the section regarding the purpose of the ROPE study and the research-related injuries section improved A-QuIC Part A and B scores for those respective areas. Specifically, in A-QuIC Part A, improvements were seen for the question related to compensation for a research-related injury (zero incorrect responses out of nine) and for the question on the purpose of the proposed ROPE study also (three unsure responses out of nine, and one incorrect response out of nine). For A-QuIC Part B, the average score for each statement was at least 86, indicating continued affirmative levels of perceived understanding of each statement. The average score for the statement regarding payment for a research-related injury increased to 86; however, remained the lowest average score of any statement. The statement’s lowest individual score for Phase 2 participants also increased to 68.

Lastly, acceptability was measured by asking all participants upon completion of the e-IC if they had any difficulties using the technology for the e-ICF. Participants did not voice any difficulties using the technology and described it as user-friendly. It was noted by the research team that participants who were interrupted during the process of the study were able to resume the e-ICF without help from the research team and, for the participants who completed all sections of the e-ICF, all were able to do so within the timeframe of their scheduled appointments.

Discussion

Our study demonstrates the development of an e-ICF using REDCap for clinical research is feasible. Furthermore, our analysis indicates the e-ICF can be understood and accepted by research participants. The results from our study complement the growing body of evidence that supports the use of e-ICFs in clinical research. For example, Rowbotham and colleagues (2013) demonstrated improved understanding when consenting with the use of an iPad-based interactive system compared to standard paper consent. Additionally, Rothwell and colleagues (2014) investigated an electronic informed consent model in a randomized controlled trial and found the electronic version improved understanding in some key aspects of the consent.

Our study also supports the use of REDCap as the platform for deploying an e-ICF. Frelich and colleagues (2015) used REDCap to develop a regulatory compliant tablet-based e-ICF and compared their e-ICF to a paper consent in clinical research for patient preference and perceived workload. Participants reported they preferred the use of the e-ICF for future research as well as noting there was no significant difference in the time and effort needed to complete the consent electronically (Frelich et al., 2015).

Further, our study’s findings suggest research participants may be able to comprehend the contents of the e-ICF without a member of the research team at their side. This supports the notion of Simon and colleagues’ (2014) study that describes the value of an e-ICF for staffing and time issues. The e-ICFs may increase the efficiency of the research team to reach more potential participants using less research staff time as research team members are not required to be present to deliver the electronic consent. As an added value, Simon and colleagues (2014) point out not having a team member during the informed consent process may be of benefit to potential participants as well because participants can review the e-ICF at their own pace.

Additionally, the use of REDCap e-ICF addresses many of the challenges of a paper consent. REDCap e-ICFs are electronically filed and therefore cannot be altered from their original submission or misplaced. Storage of the e-ICFs requires only the physical space of the servers. The use of REDCap’s specific strengths for the development and deployment of an e-ICF were multiple for our research team. For example, the development and revision of an e-ICF in REDCap was straightforward, time-efficient, and researcher-friendly with multiple in-person resources available for researchers. REDCap is compliant with HIPAA best practices as well. Compared to other types of cost-prohibitive e-ICFs, REDCap was an economical choice for our study. The ICTS, supported by the University’s Clinical and Translational Science Award, subsidized the use of the REDCap platform at the University of Iowa to all faculty, staff, and student researchers.

The use of an iPad as the tool for the e-ICF was also effective. Prior to developing the e-ICF, our team had a potential concern that participants may not be familiar with using an iPad. This concern was allayed by a United States Census Bureau Report stating among all U.S. households, 75% had a handheld wireless computer (Ryan & Lewis, 2017). This category would include tablet devices such as an iPad. Our study demonstrated the participants considered the iPad and REDCap user-friendly and did not have problems restarting the iPad and e-ICF if interrupted.

Opportunities for the Informatics Nurse

Our success in developing an e-ICF provides an opportunity for informatics nurses to further improve and refine e-ICFs for use in human subjects research. Informatics nurses have the skillset to take the lead in creating new modalities for e-ICFs that improve both user-friendliness and participant comprehension. Additionally, our study was based in a large midwestern healthcare center; therefore, the expansion of e-ICFs by informatics nurses into settings that would allow for the inclusion of understudied research subjects – who may not be able to access larger health centers – may create opportunities for researchers to obtain more representative samples for their studies.

Limitations

Limitations to our study include a small sample size. We concluded the study when we felt we could consider using an e-ICF with non-simulated patients who would be enrolled in the ROPE study and undergo study procedures. Hence, the need for future studies with real study participants in a larger prospective study.

Conclusion

We demonstrated an e-ICF created using REDCap is both feasible and well understood by research participants. The e-ICF also addresses the challenges of security and storage of a paper consent as well as increasing safety for both the research team members and potential participants by reducing contact. In addition, we have shown using REDCap to design and deploy an e-ICF was both researcher and participant friendly, as well as cost-effective. Study participants were able to maneuver through and comprehend the e-ICF when presented on an iPad without a member of the research team presenting the information. Our study’s findings add to the growing body of literature that supports the use of an e-ICF for research studies. These results will benefit future studies that consider the use of an e-ICF.