Step 4: Understand methodological issues that impact the HPRB application

Certain aspects of the research methods can impact:

  • the level of review required
  • the time required for review
  • the documents needing to be submitted (e.g., consent documents, debriefing).

If the project involves a “yes” answer to any of the following questions, please read that section for more information.

Does the research involve…?

Anonymity
Qualtrics is the preferred software for use for online surveys, because it enables researchers to collect data with no identifying information attached, making the survey truly anonymous.

PLU has a site license for Qualtrics survey software that includes use for faculty, staff, and students. Information about requesting a Qualtrics account can be found here.

Qualtrics instructions for assuring anonymity can be found here.

Informed consent
For a no-risk or low-risk anonymous online survey, investigators may request a Waiver of Documentation of Informed Consent (part of the online application in Mentor). This will allow use of an Online Cover Letter along with “click consent.” Click consent refers to the participant clicking a “begin the survey” button to indicate their consent to participate after they have read the informed consent language.

Compensation
If it is necessary to collect participant contact information in order to offer compensation (e.g., research familiarization credit, extra credit, payment), to maintain anonymity, researchers must create a separate Qualtrics form into which participants may enter only their contact information. A link to the separate form should appear at the end of the main survey so that participants do not enter their contact information in the survey, and contact information cannot be connected to their data. (Also see “Payments to Subjects” below)

Certain populations are considered more vulnerable than others because of their particular conditions or situations in life. Research involving vulnerable populations requires additional protections that must be described in the protocol. The following is a list of some—but not all—potentially vulnerable populations (see below for specific precautions to be taken for these groups):

+ Children

Children (anyone under 18 years of age) can participate as research subjects only if the research meets certain standards, defined in the federal regulations [45 CFR 46(d)]. Specifically, the research may not be greater than minimal risk unless it provides a direct benefit to the child.

Written parental/guardian permission is required for studies involving children. Once parental/guardian permission has been obtained, the agreement or assent of the child is required. This requires the researcher to explain the study in child-friendly language using an Child Oral Assent Script. While the parents/guardians must provide legal consent for the child to participate in research, the child must always assent to his/her own participation; assent being an active affirmation of a desire to participate.

Research with children will be reviewed by the full HPRB at a convened meeting. See HPRB meeting schedule here.

IMPORTANT NOTE:

The HPRB requires criminal background checks for all investigators who will have unsupervised direct contact with minors.

Many research sites already have this requirement in place (e.g., public schools, hospitals) and make provisions for having background checks completed.

If needed, PLU can help investigators obtain a background check through Washington State Patrol (for those who have lived in Washington State for the last 5 years). The cost is $12 and there are a couple of forms that need to be completed and submitted. There are alternative routes for those who have lived out of state in the past 5 years.

To initiate a background check through PLU, please contact:

Susan J. Liden
Director, Risk Management and Insurance
Pacific Lutheran University

lidensj@plu.edu
(253) 535-7116

+ Incarcerated persons

An incarcerated person is defined by federal regulations as any individual involuntarily confined or detained in a penal institution. This definition includes individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, as well as individuals being held prior to arraignment, trial or sentencing. Research involving incarcerated persons must have as its goal either a direct benefit to the individual subject or seek an understanding of issues and conditions specific to incarcerated persons.

Research with incarcerated persons will be reviewed by the full HPRB at a convened meeting.  Please see HPRB meeting schedule here.

+ Pregnant women, fetuses, and neonates

Research on pregnant women, fetuses, and neonates may not include invasive procedures unless it provides a direct benefit to the mother and only exposes the fetus to minimal risk.

Survey and interview based research involving pregnant women may be expedited or exempted from continuing HPRB review as long as the research satisfies one of the expedited/exempt criteria. However, research involving physical interventions should be reviewed by the full HPRB at a convened meeting.  See HPRB meeting schedule here.

+ Decisionally-impaired individuals

Decisionally-impaired individuals are those who have a diminished capacity for decision-making and who may be unable to fully understand the risks of research. Research may involve decisionally-impaired individuals only if it offers a direct benefit to the individual participant or to the participant’s class or condition. If the participants are not capable of giving consent for themselves, written consent must be obtained from their legal guardians (see Parent/Guardian Consent template). In that case oral assent from the subject must also be obtained.

Research involving decisionally-impaired individuals may be expedited if it is minimal risk and falls into one of the regulatory defined categories. Research with decisionally-impaired individuals will not be exempted unless it is strictly observational in nature.

+ Institutionalized individuals

Institutionalized individuals, such as those at mental health institutions require special consideration. Written permission for the conduct of the research at the institution must be obtained from the appropriate officials at that institution. In addition, if the participants are not capable of giving consent for themselves, written consent must be obtained from their legal guardians (see Parent/Guardian Consent template). In that case oral assent from the subject must also be obtained.

Research with institutionalized individuals may be expedited or exempted from continuing HPRB review if it is minimal risk and falls into one the regulatory defined categories.

Student proposals with deception require full board review. Please work with your students to help them assess whether such a project is feasible given the time constraints and the HRPB meeting schedule.

The use of deception in research raises special problems that the HPRB will review closely.

One consideration is whether the deception is necessary. An investigator proposing to use deception should justify its use. Federal regulations prohibit the use of deceptive techniques that place subjects at greater than minimal risk.

The HPRB may modify the normal informed consent process for research involving deception when subjects are not placed at risk. However, potential participants should be advised in the consent form that the information they are given is not complete and they should also debriefed after the research procedures are completed.

The debriefing should include a detailed description of the ways in which deception was used. The investigator is responsible for ensuring that the subject leaves the research setting with an accurate understanding of the deception. The debriefing process, including any written materials, should be explained to the HPRB as a part of submitted proposal. It is recommended that the following statement, or some similar statement, must appear in every consent form/information sheet for studies involving deception:

Some research designs require that the full intent of the study not be explained prior to participation. Although we have described the general nature of the tasks that you will be asked to perform, the full intent of the study will not be explained to you until after the completion of the study. At that time, we will provide you with a full debriefing which will include an explanation of the hypothesis that was tested and other relevant background information pertaining to the study. You will also be given an opportunity to ask any questions you have about the hypothesis and the procedures used in the study.

Investigators are not allowed to use entry into a lottery (e.g., for a prize, gift card, Lutebucks, etc.) as an incentive to participate. A lottery is considered a “promotional game of chance” or “free entry” contest. There is no fee to enter, and some of the people who participate win something (i.e., there is chance and a prize). Nonprofits like PLU are not allowed to hold promotional games of chance under Washington law. This is because the Legislature specifically and only allows such promotions by businesses as part of promoting their business (RCW 9.46.0356). This kind of promotion is not available to nonprofits. A 2011 attorney general’s concluded that nonprofit, charitable organizations may not conduct promotional games of chance. Educational nonprofits are specifically included in the ban.