Research participants are the primary focus for an IRB-SBS review and the purpose of the Participant Group section is to provide you with a tool that will help you to describe your participants accurately and clearly while identifying specific categories that may need the IRB-SBS’s additional attention.
There are no rules about what defines a “participant group,” rather it is a tool that will help you to better define the participants in the protocol so that you can explain your processes more clearly to the Board. Many studies will only need to create one participant group. If you have a more complex study with some participants participating in different aspects of the study, it may be beneficial to organize your participants in different groups.
Participant Group Example A
|Study Activity||Interview and survey||Survey and classroom materials||Survey|
|Consent Form||Consent form for “Teachers”||Student Assent Form
Parent Consent Form
|Parent Consent Form
(as study participants)
|Instrument||Teacher interview protocol
|Student Survey||Parent Survey|
Participant Group Example A represents a complex study with different groups of individuals who interact with the study in different ways. Creating different participant groups helps to distinguish which group will use what consent form, study instrument, etc. The different participant groups helps to distinguish between groups with adult participants and minor participants.
Participant Group Example B
|Participants||"Normal" Adult Group 1||"Normal" Adult Group 2|
|Study Activity||Anonymous Online Survey||Anonymous Online Survey|
|Consent Form||Online notification||Online notification|
|Instrument||Online Survey A||Online Survey B|
Participant Group Example B is also a complex study with different groups of individuals but their data collection and consent process is fairly similar. Even though they are taking different online surveys and may have different selection criteria, it may not be necessary to create different participant groups to describe the participants as they are all “normal” adults doing an online survey. However, it may be easier to divide the groups to better describe the selection criteria. Again, there is no rule as to the best way to use the tool but instead use your best judgement for describing your study. Once you create a participant group, you can use the participant group as a template for other groups by using the “copy” feature (select “create new participant group” and then select a group to copy), a functionality that comes in handy if you have similar participant groups.
Participant Group Example C
|Participants||Residents in a remote village|
|Study Activity||Observations, short interviews,
|Consent Form||Oral consent process|
Participant Group Example C is an ethnographic study where the researcher will spend time with a community, documenting their culture and experiences. Studies like this one can be fluid at times in regards to the specific number of participants, ages, etc. While there is the potential to interact with a variety of individuals, it may not make sense to create multiple “participant groups.” In this example the principal investigator could create just one participant group to describe the interaction with the community. However, he knows that while he will probably observe and conduct short interviews with most of the community, a select group will participate in the lengthier interviews. It may be to his advantage to create two participant groups to distinguish between the different data. He could use the “selection criteria” section to provide information as to why someone would participate in the lengthier interview, etc.
Once you create multiple participant groups, data sources, etc, the “associate tools” will help to create tables that connect the correct participant groups with consent forms and data tools, so having clearly defined participants groups is a good first step towards using these tools appropriately.
Even though the checklist above asks about “minors,” the requirements and considerations for a three-year-old minor are different than a fifteen-year-old, particularly with the assent process. This box helps the IRB-SBS have a more specific picture regarding the ages of participants.
Federal regulations define specific categories of participants who are more likely to have difficulty providing consent, either because of cognitive, legal, and/or social reasons. Participants such as minors, prisoners, and pregnant women (as related to their unborn babies) are specifically listed in the regulations but additional groups such as adults with diminished mental capacity are considered in this group as well. Students (both in participant pools and not), employees, and patients/clients can also be put in situations where they feel compelled to participate in a study depending on their relationship with the researcher. The IRB-SBS evaluates these groups more carefully and has specific requirements that need to be met. For more information, see Vulnerable Populations.
Estimated number of participants
Knowing how many participants are in a study can be a factor in determining risk, particularly in regards to confidentiality and anonymity. For many studies these numbers will not be exact but it’s important for the board to understand the scope of the study. If you apply for annual continuation, these numbers will be modified to reflect the current state of the protocol.
- Approximate number over the life of the study: Provide an estimate for the number of participants expected to enroll until study enrollment is complete.
- Total number ever enrolled: For new studies this number will be zero but as the study progresses, you will modify this number.
- Approximate number currently enrolled: For new studies this number will be zero but as the study progresses, you will modify this number.
- Future enrollment: These options describe the state of the protocol’s participant enrollment for the next year.
- Participants withdrawn: For new studies, this number will be zero but as the study progresses, you could potentially modify this number. Providing additional information regarding the reasons for participant withdrawal helps the Board understand if there are issues with the study that need to be evaluated.
Describe the participants/inclusion and exclusion criteria.
This question provides the Board with additional context regarding the participants in the study and why they would (or would not) be included in the study. Some groups may require special permission to access; for example you may need permission from a school administrator to access students in a public elementary school. You will address those issues in the “Permission to Access Data Source and Participant Group” section as well as upload proof of permission in the “Proof of Permission” upload.
The purpose of this question is twofold. First, the IRB-SBS must evaluate the ethical implications of paying a participant and ensure that payment is commensurate with the participant’s study activities. In addition, the Procurement Office has asked for our help to accurate report paying participants with UVA funds. For more information see Paying Participants.
- Select the “create a new group” link.
- Provide the group’s name in the text box. Select “Continue” to save data and return to the main protocol view.
- You will see a “Protocol was successfully updated” message. Click on the “return to protocol” link to continue adding content to the protocol.
- If you need to create additional participant groups, go back to the “create a new group” link. If there is one or more participant groups, you can “copy” that participant group and use the content you already created as a template for a new participant group. You can edit the text as needed once the new group is created.
- Once a participant group is created, find the new group in the “Participant Groups” list and select “goto” or simply scroll down the page to find it.
- Select “Edit all” or select individual questions to edit the content. When you are done with edits, select “Continue” to save data and return to the main protocol view.
- Participant groups can be deleted by clicking the “delete” box on the right side of the participant group and confirming the deletion on the next page. Please note: if a participant group is associated with a data tool or consent form, the association is also deleted. You may need to revisit the association tools to make sure that they are correct.
- This participant group is described in sufficient detail.
- Pre-Reviewer will determine if the participant group qualifies for a waiver of consent or waiver of documentation of consent.
- (If participants are compensated) Subjects have been informed properly regarding the details of payment. Specifically if they are required to provide their social security numbers in order to receive payment, the participants are informed.
Checklist items specific to vulnerable populations
- (ward of the state) Study includes procedure to appoint an experienced advocate (not associated with research or guardian organization) for each child who is a ward in addition to parent/guardian (can be the same individual for more than one child).
- (ward of the state) Study is related to minor’s status as a ward of the state or it is conducted in a location where the majority of the participating children are not wards.
- (pregnant participant) Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate; (Note: if there is a risk to the fetus, the study needs to be reviewed by the HSR)
- (pregnant participant) The study is research limited to non-medical observation, interviews, surveys or analysis of archival data, informational risks of potential disclosure of research data or risks of emotional upset to the research questions. The research does not exclusively target the fetus or involve neonates of uncertain viability or nonviable neonates. (Note: if the study doesn’t fit this definition, it needs to be reviewed by the HSR)
- The number of participants seems reasonable in relation to the study design and intent.
- (If study doesn’t include vulnerable populations) The participant group is reasonable for this study.
- The number of participants seems reasonable in relation to the study design and intent.
- (If participants are compensated) The compensation is commensurate with the level of respondent effort.
- (If participants are compensated) The compensation offered is appropriate for the study.
When study requires a waiver of consent and/or waiver of documentation of consent
- The Board finds and documents that the protocol meets the requirements for waiver or alteration of consent or assent.
- The Board finds and documents that the protocol meets the requirements for the alteration of consent or assent.
- The Board finds and documents that the protocol meets the requirements for waiver or alteration of parental or surrogate consent.
- The Board finds and documents that the protocol meets the requirements for the alteration of parental or surrogate consent.
- The Board finds and documents that the protocol meets the requirements for waiver of documentation of consent or assent.
- The Board finds and documents that the protocol meets the requirements for waiver of parental or surrogate consent.
- The Board finds and documents that the study is screening, recruiting, and/or determining eligibility and does not require consent at this time.
- The IRB-SBS Reviewer will confirm that a participant group qualifies for a waiver of documentation of consent (where applicable).
Checklist items specific to vulnerable populations:
- (VP any) Appropriate measures are included to protect vulnerable participants where and when the research occurs, how their information is managed and protected, and who interacts with them.
- (VP any) The engagement of this population is necessary to answer the research question for the study.
- (VP any) The research is of importance to this vulnerable population.
- (VP any) The research question can’t be answered by using a non-vulnerable population.
- (community based research) Appropriate precautions have been taken by the researcher to protect community members from coercion.
- (community based research) The community members who participate in the conduct of the research will be appropriately trained and supervised.
- (community based research) The community was appropriately involved or consulted in defining and/or developing the proposed research.
- (community based research) The research outcomes will be disseminated appropriately to the community.
- (community based research) The research procedures, including recruitment strategies and consenting processes, are appropriate for this community and/or culture.
- (community based research) There is a clear separation between when community members act as researchers and when they are participants in the research.
- (diminished mental capacity) The process for determining capacity to consent is adequate.
- (minors, greater than minimal risk) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition.
- (minors, greater than minimal risk) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations.
- (minors, greater than minimal risk) The risk represents a minor increase over minimal risk.
- (minors, greater than minimal risk) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children. Review by OHRP required.
- (ward of the state) Study procedure to appoint an experienced advocate (not associated with research or guardian organization) for each child who is a ward in addition to parent/guardian (can be the same individual for more than one child) is adequate.
- (pregnancy) Any risk to pregnant participants is the least possible for achieving the objectives of the research.
- (pregnancy) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.
- (pregnancy) Individuals engaged in the research will have no part in determining the viability of a neonate.
- (pregnancy) No inducements, monetary or otherwise, will be offered to terminate a pregnancy.
- (pregnancy) There is no risk to the fetus and the fetus is not the target of the study.
- (pregnancy) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses.
- (minor and pregnancy) For children who are pregnant, assent and permission are obtained in accord with the provisions of the Protections for Children Involved as Subjects (Subpart D).
- (prisoners) Any need for post study care for prisoners is appropriately provided including taking into account the varying lengths of prisoners’ sentences and for informing participants of that fact.
- (prisoners) The procedures for the selection of participants within the prison is fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners.
- (prisoners) The risks to prisoners involved in the research is commensurate with the risks that would be accepted by non-prisoner volunteers.
- (prisoners) There are no possible advantages to the prisoners through their participation in the research, when compared with the general living conditions, medical care, quality of food, amenities and opportunity for earning in the prison, that are of such a magnitude that the potential participant's ability to weigh the risks of the research against the value of such advantages is impaired.
- (prisoners) There is assurance that court system/judicial system will not take into account a prisoner’s participation in research in making decisions regarding the legal case.
- (prisoners) You have no association with the involved prisoners which might be viewed as a conflict of interest.