The Eval Section - Part #2: Protecting Participants: Confidentiality, Privacy, and Informed Consent
For our second installment of the four-part blog series to help de-mystify the world of data and program evaluation in federal grant proposals, our focus is on protecting participants in program evaluation design with a focus on confidentiality, privacy, and informed consent. Topics include:
Program evaluation vs research
Considering human subjects protection in grant proposals
What is informed consent?
Special protections for vulnerable populations, including children and youth.
Privacy and confidentiality explained
While many of the issues discussed in this blog post are relevant across a number of disciplines, this post is primarily geared toward organizations who are conducting social and behavioral evaluations of programs and activities in the areas of human services, behavioral health, youth services/education, and housing.
Program Evaluation vs. Research
When designing a program evaluation for your grant proposal, a good first step is to determine whether your evaluation meets the criteria for human subjects research. This is defined in the HHS 2018 Common Rule as:
Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subjects: A living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
The key here is “generalizable knowledge”. If you are conducting research with the intention of producing results that are generalizable and contribute to scientific inquiry, then your evaluation may meet the qualifications for human subjects research.
Why does this matter? If your program evaluation intends to contribute to generalizable knowledge, you then must have your evaluation design reviewed and approved by an Institutional Review Board, or “IRB”, to ensure the protection of human subjects.
Many universities have IRBs. There are also independent IRBs that organizations can use to review their evaluation designs. If you’re not sure if your program design meets the criteria needed for an IRB, you should always consult with one to determine if your program evaluation would meet the criteria of human subjects research.
Some organizations may consult with or otherwise elect to have their program evaluation design reviewed by an IRB even if they don’t - by the letter of the definition - meet the criteria for human subjects research. Staff and reviewers from IRBs are experienced professionals who can provide guidance unique to your project to ensure that it meets standards for the protection of human subjects.
Note: You don’t have to have an IRB review completed prior to submitting the grant proposal. You may decide to write-in funds that would pay for the review of your proposal by an IRB or that would pay for a qualified professional to provide guidance on your evaluation design.
Organizations who are conducting a simple program evaluation could determine that their evaluation does not meet the criteria of human subjects research. However, best practices in program evaluation will still draw on many of the same principles and approaches outlined in official documents guiding research like the Belmont Report and Common Rule. The next sections outlines some of these key principles to incorporate into your program evaluation design in your federal grant proposals.
Human Subjects Protection in Grant Proposals
Many federal grants have specific sections that ask for you to describe procedures for data collection and also ask you to describe policies and procedures you will develop to ensure the protection of participants. The Belmont Report, which is a report that outlines ethical principals for human subjects research and is used by researchers, outlines three main principles:
Respect for Persons: Protect individual autonomy, provide procedure for informed consent.
Beneficence. Maximize benefits and minimize risks, “do no harm”
Justice - Risks and benefits for potential participants should be distributed equally.
When writing the data and evaluation section of your grant proposal, it can be helpful to use these three principles to guide your writing. One recent funding announcement asked grant applicants to examine:
How applicants will protect participants and staff from potential risks - this includes specifying risks for participants and how they will protect against them. Often, this means how they will train and prepare staff to support individuals if they have an adverse effects.
How applicants will ensure fair treatment - in particular, specifying how applicants will select participants to participate in program activities and the evaluation of these activities.
How applicants will ensure absence of coercion - this includes many factors, but may ask applicants to identify specifically how they will compensate individuals for participation using financial incentives. Incentives should help participants, but should not be so high as to provide undue pressure on individuals to participate.
It’s critical to develop strong procedures in your proposals to address these questions. The more you can show that you are thinking about the potential risks and challenges in advance and that you have developed procedures to address them, the more competitive your grant proposal will be.
Informed Consent
Informed consent is a process by which the participants of the evaluation are given the opportunity to learn about the evaluation prior to beginning and to then offer their consent - their “yes” - to participate. A key here is that participation in evaluation should be voluntary, which respects the autonomy of the individual participating.
Many federal grant proposals will ask that you submit examples of informed consent documents as attachments with the grant proposal. Strong grant proposals demonstrate that the organization has developed and is capable of implementing strong procedures for informed consent.
So what should be included in an informed consent? You can refer to the Common Rule and also discuss with an Institutional Review Board requirements for informed consent procedures. In general terms, it will include (but is not limited to) a discussion of the program evaluation, what procedures/activities are involved, the risks and benefits for participation, how data will be protected/kept confidential in the evaluation, and how participants can contact individuals with questions. For a full list of requirements, refer to Common Rule and/or discuss your consent forms with an Insitutational Review Board.
In practical terms: if you are conducting a survey, focus group, or other data collection activity with program participants, you should design a procedure to obtain informed consent from program participants. In many cases, this procedure will include a voluntary written informed consent document to share with program participants prior to conducting the data collection. However, informed consent is not just about a written document, but encompasses an entire process by which individuals can provide their consent to participate in a program evaluation. It will be important to consider how to appropriately train staff and program representatives to lead an informed consent process with program participants.
Note that informed consent in this article refers just to the informed consent for participating in the evaluation of the program. Many organizations will also have a separate informed consent form that is included for enrollment/participation in the program, which may also be included as an appendix in your grant proposal.
Special Protections
The informed consent process also requires additional considerations for protected groups with diminished autonomy or decision-making capacity. Explicitly, this includes pregnant women, children, and prisoners, but it is also broadened to include anyone with diminished capacities. For example, if a nonprofit serves adults with developmental disabilities, additional protections should be taken into consideration when designing an informed consent procedure.
Many organizations provide programs and services for families with children. One issue that arises for many organizations is the need for parents and/or legal guardians to provide consent for their child(ren) to participate in an evaluation. Organizations should consider how they can include parents and legal guardians in the consent procedure and consult with a qualified professional or Institutional Review Board on how this might impact their specific program evaluation study.
Privacy and Confidentiality
Federal grant opportunities may also ask you to explicitly address how you will protect the privacy and confidentiality of program participants.
In general, privacy refers to people - that is, how people can have control over access to information about themselves. For example, one way to protect participant privacy is to only ask for/discuss information about a person that is needed to complete the evaluation. Additionally, considerations should be made about the when, where, and how you contact people to participate in the evaluation.
Confidentiality refers to data - that is, the procedures that you take to maintain the security of data about individual people. A strong evaluation design will develop policies and procedures regarding the storage, handling/use, and sharing or transfer of program evaluation data. This information can also be included in the informed consent document/procedure that is shared with participants prior to participating, so they can adequately assess risks prior to their participation.
In practical terms, here are some key things (though not an exhaustive list) to consider when creating your grant application in order to protect participant privacy and confidentiality:
How, when, and where will your evaluation take place? And will the answers to these questions potentially place participant privacy at risk?
Is your survey or focus group protocol too long? Do you really need to ask all of the questions on the survey, or can it be reduced to minimize the amount of information gathered from the participants?
How are you storing your data? What procedures for restricting access and data security protocols should you consider to ensure data are only accessed by authorized individuals? What procedures are you developing that outline how data will be stored, accessed, used, or shared?
Each organization will need to consider how they can protect the privacy of individuals and maintain the confidentiality of the data they collect.
Up Next
This article is the second of a four-part series on writing the evaluation section of your federal grant proposals. Upcoming topics include:
Part #3: Data Analysis
Part #4: Reporting, Communication, Continuous Improvement
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Note: this blog post is for informational purposes only does not, and is not intended to, constitute legal or medical advice. Readers of this blog post should contact their attorney to obtain advice with respect to any particular legal matter.
