Special Populations Research

Research involving populations from clinical counseling, rehabilitation centers, retirement and/or convalescent homes (and similar institutions), children and other vulnerable populations pose a special responsibility for the researcher. Research projects dealing with these populations should be guided by the following general principles:

1. Access to confidential files should be obtained in a legal and ethical manner. The researcher is obligated to maintain confidentiality of information obtained. Access to confidential information as a result of one’s employment does not entitle one to use such data for one’s own research. Explain if you have access from your job, but not as a researcher. 
2. In situations in which the experimenter has professional contact with the prospective subject, as in a therapist-client relationship, the solicitation of the client for participation in that research project should be conducted through a third party
3. For research with the following special populations, follow the appropriate guidelines noted:
   Fetuses, pregnant women, human in vitro:
   https://www.hhs.gov/ohrp/regulations-and-policy/regulations/regulatory-text/index.html
   (Belmont Report, 45CFR46, B 46.201-46.211)
   Cognitively impaired:
   http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111
   Children:
   http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartd (Belmont Report, 45CFR, 46.401-46.409)
4. All projects with infants (under 3 years) or those not conducted in a school setting require the permission of at least one parent. If the project involves access to school or medical records, permission for the researcher to access these records should be explicitly solicited from the parents as well as the school aged child and be part of the respective Informed Consent.
5. All projects involving children which require a full review process and require the permission of both parents. In a setting where the child does not live with both parents, the permission of the legal guardian or the custodial parent is required, unless otherwise determined by the IRB.
6. In all research projects involving children, participation must be terminated at any time at the request of the parent or child.
7. If subjects will be minors (under 18 years of age), in addition to a parental permission form: a separate Informed Consent for minors over age 12 (Assent Form) is required in age appropriate language.
8. Parents of Children must be provided with actual and entire tests to be given that are not in the usual discourse of school.

An oral assent procedure or script is required for individuals between 12 and 18, and another for children under age 12.

Assent form (for children between 12-18 years): 

1. on Seton Hall University department or school letterhead;
2. includes all the information as required in the Informed Consent form;
3. the language used is age-appropriate;
4. has a place for child and parent/guardian to sign and date Assent Form;
5. states that a copy is provided for child and parent/guardian.

Assent Script (for children under 12 years old): 

1. on Seton Hall University or school letterhead;
2. the language used is age-appropriate;
3. oral Assent Procedure or Script includes all the information as required in the Informed Consent form;
4. has a place for child and parent/guardian to sign and date Oral Assent Procedure or script
5. states that a copy is provided for child and parent/guardian.