|
Policy and procedures for the conduct of research involving
human subjects
How to apply
If a project requires Board approval, obtain a copy of the Board proposal
form by downloading it from this site. Fill out the Board review form and send
it to the Board by campus mail (Office of Sponsored Research, 101 Mary Lyon
Hall) U.S. mail (50 College Street, South Hadley, MA 01075), or preferably
as an e-mail attachment to the IRB.
If a proposal is sent by e-mail attachment, an original copy with required
signature(s) must follow in the mail. Note
that all student proposals must also be signed by a Faculty Supervisor who
attests
that s/he has read and approves of the proposal. Researchers are strongly encouraged
to submit proposals as an e-mail attachment to expedite the review
process. The Board will acknowledge receipt of all proposals.
Links to Required forms (NOTE: The IRB proposal form and sample consent forms
have changed. Please use the current forms for all submissions.)
Download a copy of the IRB review form (pdf
format)
IRB review form to send as an attachment.
Download an example of an informed consent statement: (Note that these are
samples only which do not cover every potential proposal)
(written consent form)
(oral consent form )
Informed consent
While most proposals will require a process for obtaining informed consent,
in some cases, especially for projects that involve deception, fully informed
consent may not be practical. The Board may approve a consent procedure that
does not include, or alters any or all of the elements of informed consent,
if and only if:
The research involves no more than minimal risk to the subjects;
The waiver or alteration of informed consent will not adversely affect the
rights and welfare of the subjects;
The research could not be carried out practicably without the waiver or alteration
of informed consent.
When appropriate, the subjects will be provided additional pertinent information
about the research after they have participated.
Further information about the requirements for documenting informed consent
is available through
this link. Please consult with the Board if you need advice
about specific requirements for obtaining informed consent orally or in writing.
Special note on non-English speaking subjects
When subjects do not speak or understand English well, the researcher must
prepare documents in the language that subjects can understand. The researcher
must provide to the Institutional Review Board a copy of the document(s) in
English, a copy in the language to be used, and a letter from an unbiased individual
with expertise in the language (e.g., a Mount Holyoke College faculty member)
indicating that the translated version is complete and contains the same information
as the English version.
Special note on research in foreign countries
When faculty, staff, or students conduct research with human subjects in a
foreign country, there may be cultural differences that should be considered.
Some of the differences are listed below.
Language: When documents must be translated into a language other than English,
the researcher should provide a copy of the document in English, a copy in
the language to be used, and a letter from an unbiased individual with expertise
in the language (e.g., a Mount Holyoke College faculty member) indicating that
the translated version is complete and contains the same information as the
English version.
Minors: When subjects are younger than 18 years of age, researchers are required
to get written parental permission. However, if local regulations are such
that parental permission for research in a school setting would be inappropriate,
the researcher must give the Board proof that this is inappropriate. For example,
proof could be a letter saying that parental permission would be inappropriate
from an authorized official in the country, or from a Mount Holyoke College
faculty member who is familiar with the culture.
Audio/video taping: When researchers audio/video tape subjects, the Board
requires a signed consent form. But in some cultures, subjects would be reluctant
to sign an official form. This should be explained in the application, and
the Board will consider alternative means of documenting consent such as obtaining
verbal consent on the tape. Subjects must be informed of their rights, confidentiality,
and all other aspects of consent.
Click here to return to Main Page of Policy or Click here to go to next section
(How and When Proposals are Reviewed)
|
